brAIn Shoulder Positioning
K243292Avatar Medical · cleared 2025-03-20 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The brAIn™ Shoulder Positioning software is a cloud-based application intended for shoulder surgeons.”
source quote (p.6)
“The software automatically segments (using machine learning)”
source quote (p.9)
“Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”
Validation studies (4)
Bench
n=508 images
endpoints: Dice Similarity Coefficient (DSC) >= 0.95
standards: ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submission for Management of Cybersecurity in Medical Devices.
Bench
sample size not stated
endpoints: compliance with the required performance standards for shoulder side detection
Bench
sample size not stated
endpoints: compliance with the required performance standards for measurement accuracy
Bench
sample size not stated
endpoints: accuracy similar to manual positioning with a 3 mm mean distance as the acceptance criterion
Reported performance (1 observation)
source quote (p.9)
“meeting a mean Dice Similarity Coefficient (DSC) on the testing set greater than or equal to 0.95.”
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
- 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). 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).