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AEQUALIS Shoulder Range (except AEQUALIS for Fracture): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. i Primary and secondary necrosis of the humeral head - Displaced 4-part upper humera! fracture । - Humeral head fracture । - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other treatments or devices have failed. - AEQUALIS for Fracture: Traumatic or pathologic conditions of the shoulder resulting in fracture of the Fraumatio of painting of joing humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

Total-Shoulder System and Hemi-Shoulder System. Shoulder joint metal/polymer semi-constrained cemented prosthesis.

This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System, AEQUALIS Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/software as a medical device.

The provided text is a regulatory filing for a physical medical device (shoulder prosthesis), focusing on establishing substantial equivalence to previously marketed predicate devices. It lists indications for use, device classification, and administrative details for FDA approval.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3-or 4-part proximal humeral fractures.

The usual goal of total shoulder replacement is to relieve or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid is replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthroplasty to a total shoulder replacement. The present Device Modification submission consists in the addition of a long stem to each diameter of the previous range.

This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System), not a study report. Therefore, it does not contain the information required to describe acceptance criteria and a study proving the device meets those criteria.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the regulatory requirements for marketing, but it does not involve a specific clinical study with acceptance criteria and a detailed performance evaluation as would be found in a clinical trial report.

Here's why the requested information cannot be extracted from the provided text:

1. Acceptance criteria and reported device performance: This document does not detail specific acceptance criteria for performance metrics (e.g., success rates, complication rates, range of motion improvements) or report any performance data from a study.
2. Sample size, data provenance: No study is described, so no sample size or data origin is mentioned.
3. Number of experts, qualifications, adjudication method: These pertain to establishing ground truth in a clinical or imaging study, which is not present here.
4. MRMC comparative effectiveness study: No such study is mentioned or implied.
5. Standalone (algorithm only) performance: This is a physical implant, not an algorithm.
6. Type of ground truth: Ground truth is not relevant in this context, as no performance data based on ground truth is being presented.
7. Training set sample size/ground truth: This pertains to machine learning models, which is not what this document is about.

In summary, the provided text is a regulatory filing for marketing clearance, not a scientific or clinical study report.

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