brAIn™ Shoulder Positioning

K243292

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

FDA 510(k) summary for brAIn™ Shoulder Positioning (K243292)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
4
Cited predicates
1
Performance observations
2
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
32
drift signals on this device
  • predicate_cohort_contagion

    K243292 shares predicate K213922 with K252665 (brAIn™ Shoulder Positioning), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K213922 sibling:K252665

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • …and 26 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 2026-09-02.

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.

Related FDA clearances

More AI/ML devices under product code LLZ

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

K251532

Mighty Oak Medical

cleared 2025-11-03

SurgiTwin

K250290

Twinsight

cleared 2025-08-29

Neuro Insight V1.0

K243681

Olea Medical S.A.S.

cleared 2025-07-23

GyriCalc (Version 1.0.0)

K250686

NeuroSpectrum Insights Corp.

cleared 2025-07-22

VersaViewer

K243651

GE Medical Systems SCS

cleared 2025-04-21

aiCockpit AI Viewer

K241546

Fovia, Inc.

cleared 2025-02-26

QuickRad

K242838

Aikenist Technologies Pvt Ltd

cleared 2025-02-21

CaRi-Plaque

K242240

Caristo Diagnostics Ltd.

cleared 2025-02-20

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243292