brAIn™ Shoulder Positioning

K243292

Avatar Medical · cleared 2025-03-20 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The brAIn™ Shoulder Positioning software is a cloud-based application intended for shoulder surgeons. It is used to plan primary anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's shoulder CT-scan (DICOM series) accompanied with their information in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series.”
Algorithmmachine learning
source quote (p.6)
“The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“Additionally, the software validation activities were performed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."”

Validation studies (4)

Bench

n=508 images

endpoints: Dice Similarity Coefficient (DSC) coefficient of 0.95 or higher

standards: ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes

Bench

sample size not stated

endpoints: compliance with the required performance standards

Bench

sample size not stated

endpoints: compliance with the required performance standards

Bench

sample size not stated

endpoints: accuracy similar to manual positioning with a 3 mm mean distance as the acceptance criterion; compliance with the required performance standards

Reported performance (2 observations)

diceas written: “Dice Similarity Coefficient (DSC)”0.95
source quote (p.9)
“The brAIn™ system's automatic segmentation was validated against manual segmentation, meeting a mean Dice Similarity Coefficient (DSC) on the testing set greater than or equal to 0.95.”
accuracyas written: “Landmark accuracy (mean distance)”3
source quote (p.10)
“Validation compared pre-positioning with final positions adjusted by experts, achieving accuracy similar to manual positioning with a 3 mm mean distance as the acceptance criterion.”

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
27
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252665 (decision 2025-10-20) from Avatar Medical for a matching device line ("brAIn™ Shoulder Positioning") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252665

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98428

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98137

  • …and 21 more.

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/K243292