TechCare Trauma

K242171

Milvue · cleared 2025-01-17 · product code QBS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.8)
“The TechCare Trauma device is a software as Medical Device (SaMD).”
Algorithmartificial intelligence algorithm, Supervised Deep Learning
source quote (p.8)
“TechCare Trauma uses an artificial intelligence algorithm to analyze acquired medical images (2D X-ray radiographs) for features suggestive of fractures and elbow joint effusions. Supervised Deep Learning”
Adaptive (vs locked)No
source quote (p.11)
“TechCare Trauma operates based on two fixed operating points, which determine the result status of each finding:”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=7,744 images · 4 site(s)

endpoints: image-level Area Under The Curve (AUC) of the Receiver Operating Characteristic (ROC)

Reader study (MRMC)

n=769 cases

endpoints: case-level AUC of the ROC curves

Reported performance (32 observations)

sensitivity0.906CI [0.891; 0.919]
source quote (p.19)
“Se (High Sp) 0.906 [0.891; 0.919]”
specificity0.9CI [0.887; 0.912]
source quote (p.19)
“Sp (High Sp) 0.900 [0.887; 0.912]”
aurocas written: “auc”0.962CI [0.957 - 0.967]
source quote (p.17)
“Fracture - Adult (4109) 0.962 [0.957 - 0.967]”
aurocas written: “AUC Fracture - Pediatric”0.962CI [0.955 - 0.969]
source quote (p.17)
“Fracture - Pediatric (2872) 0.962 [0.955 - 0.969]”
aurocas written: “AUC EJE - Adult”0.965CI [0.936 - 0.986]
source quote (p.17)
“EJE - Adult (280) 0.965 [0.936 - 0.986]”
aurocas written: “AUC EJE - Pediatric”0.976CI [0.963 - 0.986]
source quote (p.17)
“EJE - Pediatric (483) 0.976 [0.963 - 0.986]”
sensitivityas written: “Sensitivity (High Se) Fracture - Adult”0.94CI [0.928; 0.951]
source quote (p.19)
“Se (High Se) 0.940 [0.928; 0.951]”
specificityas written: “Specificity (High Se) Fracture - Adult”0.845CI [0.830; 0.859]
source quote (p.19)
“Sp (High Se) 0.845 [0.830; 0.859]”
sensitivityas written: “Sensitivity (High Sp) EJE - Adult”0.821CI [0.719; 0.893]
source quote (p.19)
“Se (High Sp) 0.821 [0.719; 0.893]”
specificityas written: “Specificity (High Sp) EJE - Adult”0.98CI [0.949; 0.993]
source quote (p.19)
“Sp (High Sp) 0.980 [0.949; 0.993]”
sensitivityas written: “Sensitivity (High Se) EJE - Adult”0.859CI [0.764; 0.923]
source quote (p.19)
“Se (High Se) 0.859 [0.764; 0.923]”
specificityas written: “Specificity (High Se) EJE - Adult”0.955CI [0.917; 0.978]
source quote (p.19)
“Sp (High Se) 0.955 [0.917; 0.978]”
sensitivityas written: “Sensitivity (High Sp) Fracture - Pediatric”0.9CI [0.882; 0.916]
source quote (p.19)
“Se (High Sp) 0.900 [0.882; 0.916]”
specificityas written: “Specificity (High Sp) Fracture - Pediatric”0.927CI [0.913; 0.938]
source quote (p.19)
“Sp (High Sp) 0.927 [0.913; 0.938]”
sensitivityas written: “Sensitivity (High Se) Fracture - Pediatric”0.93CI [0.914; 0.943]
source quote (p.19)
“Se (High Se) 0.930 [0.914; 0.943]”
specificityas written: “Specificity (High Se) Fracture - Pediatric”0.875CI [0.859; 0.891]
source quote (p.19)
“Sp (High Se) 0.875 [0.859; 0.891]”
sensitivityas written: “Sensitivity (High Sp) EJE - Pediatric”0.669CI [0.587; 0.744]
source quote (p.19)
“Se (High Sp) 0.669 [0.587; 0.744]”
specificityas written: “Specificity (High Sp) EJE - Pediatric”0.977CI [0.954; 0.989]
source quote (p.19)
“Sp (High Sp) 0.977 [0.954; 0.989]”
sensitivityas written: “Sensitivity (High Se) EJE - Pediatric”0.901CI [0.839; 0.941]
source quote (p.19)
“Se (High Se) 0.901 [0.839; 0.941]”
specificityas written: “Specificity (High Se) EJE - Pediatric”0.933CI [0.901; 0.955]
source quote (p.19)
“Sp (High Se) 0.933 [0.901; 0.955]”
aurocas written: “Reader ROC AUC (Adult fracture)”0.955
source quote (p.22)
“Average ROC curve with Al (area = 0.955)”
aurocas written: “Reader ROC AUC (Adult EJE)”0.914
source quote (p.22)
“Average ROC curve with Al (area = 0.914)”
aurocas written: “Reader ROC AUC (Pediatric fracture)”0.931
source quote (p.23)
“Average ROC curve with Al (area = 0.931)”
aurocas written: “Reader ROC AUC (Pediatric EJE)”0.94
source quote (p.23)
“Average ROC curve with Al (area = 0.940)”
sensitivityas written: “Reader Sensitivity (Adult fracture)”stated without valueCI 0.966-0.996
source quote (p.20)
“Reader Sensitivity significantly improved from 0.807 (95% CI: 0.737-0.865) to 0.983 (95% CI: 0.966-0.996): +21.8% increase of the Sensitivity”
specificityas written: “Reader Specificity (Adult fracture)”stated without valueCI 0.734-0.901
source quote (p.20)
“Reader Specificity improved from 0.815 (95% CI: 0.724-0.886) to 0.827 (95% CI: 0.734-0.901): +1.47% increase of the Specificity”
sensitivityas written: “Reader Sensitivity (Adult EJE)”stated without valueCI 0.862; 0.959
source quote (p.20)
“Reader Sensitivity significantly improved from 0.851 (95% CI: 0.783; 0.913) to 0.914 (95% CI: 0.862; 0.959), a delta of 0.064 [0.026; 0.101] (p < 0.001).”
specificityas written: “Reader Specificity (Adult EJE)”stated without valueCI 0.645-0.845
source quote (p.21)
“Reader Specificity improved from 0.738 (95% CI: 0.635-0.835) to 0.746 (95% CI: 0.645-0.845): +1.08% increase of the Specificity”
sensitivityas written: “Reader Sensitivity (Pediatric fracture)”stated without valueCI 0.940-0.984
source quote (p.21)
“Reader Sensitivity significantly improved from 0.804 (95% CI: 0.747-0.864) to 0.964 (95% CI: 0.940-0.984): +19.9% increase of the Sensitivity”
specificityas written: “Reader Specificity (Pediatric fracture)”stated without valueCI 0.700-0.882
source quote (p.21)
“Reader Specificity remained the same at 0.797 (95% CI: 0.700-0.873) to 0.797 (95% CI: 0.700-0.882): 0% increase of the Specificity”
sensitivityas written: “Reader Sensitivity (Pediatric EJE)”stated without valueCI 0.939-1.000
source quote (p.21)
“Reader Sensitivity significantly improved from 0.825 (95% CI: 0.742-0.895) to 0.975 (95% CI: 0.939-1.000): +18.2% increase of the Sensitivity”
specificityas written: “Reader Specificity (Pediatric EJE)”stated without valueCI 0.769-0.926
source quote (p.21)
“Reader Specificity improved from 0.839 (95% CI: 0.764-0.914) to 0.851 (95% CI: 0.769-0.926): +1.43% increase of the Specificity”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242171