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The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. The glenoid baseplate features a medial boss through which a Central Screw is placed to hold the component in place. Additionally, there are four peripheral screw holes through the baseplate for screw fixation. The screws are available in both locking and non-locking styles. Both sterile and non-sterile versions of the screws will be marketed.

This 510(k) is for a design modification to the peripheral screws as well as the inclusion of non-sterile central and peripheral screw options to allow sterilization of the screws at the user facility in a screw caddy.

This document is a 510(k) premarket notification for the Comprehensive® Reverse Shoulder - Screws. It's a regulatory filing for a medical device, not a study evaluating an AI algorithm or diagnostic tool. Therefore, the information requested about acceptance criteria, study details, and AI performance is not applicable to this document.

Here's why each of your requested points cannot be answered from this document:

• 1. A table of acceptance criteria and the reported device performance: This document reports on a physical medical device (shoulder screws) and evaluates its substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Torque to Failure). It does not present performance data in the context of diagnostic accuracy, sensitivity, or specificity, which are typical for AI-based medical devices or diagnostic studies.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The "test set" here refers to the physical screws subjected to mechanical testing. There is no mention of data provenance in the context of patient data, as this is not a clinical study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): "Ground truth" in this context would implicitly be the engineering specifications and performance limits for the screws, not established by medical experts for diagnostic purposes.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing of screws.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device or a diagnostic reading study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As mentioned, the "ground truth" relates to mechanical engineering specifications and performance, not clinical outcomes or pathology from patient data.
• 8. The sample size for the training set: Not applicable, as there is no AI algorithm being trained.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI algorithm being trained.

In summary, this document is a regulatory submission for a physical orthopedic implant (screws for a shoulder replacement), not a study evaluating an AI device or diagnostic algorithm. Therefore, the requested information pertaining to AI performance and clinical study design for AI is not present. The document focuses on demonstrating that the modified screws are substantially equivalent to previously marketed screws based on design and non-clinical performance data (specifically torque to failure).

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