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Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System): 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. Primary and secondary necrosis of the humeral head Displaced 4-part upper humeral 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 Shoulder Fracture System 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. Revision surgery when other treatments or devices have failed.

The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems. The Affiniti pegged glenoid components are available in sizes 40 - 56.

The provided text is a 510(k) summary for a medical device (Aequalis Shoulder System and Fracture System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or even a standalone technical performance study.

Therefore, the document does not contain the information requested about acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance.

The reason for this is that the submission states:

"The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously."

This indicates that the submission is for a minor modification (compatibility with new glenoid components) to an already cleared device, relying on the substantial equivalence principle rather than new performance testing.

However, I can extract the following information based on the provided text:

• Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System
• Device Type: Total shoulder prosthesis (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
• Classification: Class II
• Product Codes: 87 KWS
• Predicate Devices: K994392, K003728, K012212, K032679, K060209 (for Fracture System) and K952928, K980244, K012212, K041339, K043077, K060209, K060988 (for Shoulder System).

In summary, there is no information in the provided document to answer the questions about acceptance criteria and device performance studies because the submission is based on substantial equivalence to predicate devices, not new performance data.

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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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