MuscleView

K241331

Springbok, Inc. · cleared 2024-10-01 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“MuscleView is a software only product that uses a machine learning-based approach for the automatic segmentation of musculoskeletal structures from MRI.”
Algorithmmachine learning-based approach, specifically convolutional neural networks (CNNs)
source quote (p.6)
“MuscleView is a software only product that uses a machine learning-based approach for the automatic segmentation of musculoskeletal structures from MRI. A library of already contoured expert cases is utilized to train the machine learning algorithms, specifically convolutional neural networks (CNNs) perform automated segmentation.”
Adaptive (vs locked)Yes
source quote (p.6)
“The segmentation & 3D model viewer module handles training data and algorithms to obtain the pre-trained models and algorithms to update models.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=148 scans · 19 site(s)

endpoints: dice similarity coefficient (DSC); volume difference (VDt); one-sample T-test between the results of the validation set and the acceptance criteria threshold (the 95% confidence interval from the interobserver repeatability of manually vetted labels)

Reported performance (1 observation)

diceas written: “Dice Similarity Coefficient (DSC)”stated without valueCI For the 95% confidence interval for all structures and subgroups, see Table 4 (DSC) and Table 5 (VDt).
source quote (p.13)
“For the 95% confidence interval for all structures and subgroups, see Table 4 (DSC) and Table 5 (VDt).”

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

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98779

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98111

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/K241331