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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.

Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

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 Macro Bond® 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 device is a single-use implant.

The Titanium Alloy Glenosphere Prosthesis consists of a series of various sized modular glenospheres with variable offset between 0.5mm and 4.5 mm. Titanium alloy material has been selected to provide the surgeon with an alternate material to treat patients with nickel allergies. Each modular glenosphere consists of a "head" and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Reverse Shoulder System or Biomet's BioModular® Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device, specifically the Comprehensive® Reverse Shoulder - Titanium Glenosphere. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving that the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics (like sample size for test sets, expert ground truth, effect size, etc.) are not applicable or not provided in this type of regulatory submission. The document explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."

However, I can extract the relevant information that is present:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The performance reported here is primarily related to non-clinical bench testing.

Detailed Study Information (Not applicable/Not provided in this document type):

As noted, this document is a 510(k) summary demonstrating substantial equivalence, not a clinical study report with detailed performance data against specific acceptance criteria. Therefore, the following information is not present:

2. Sample sizes used for the test set and the data provenance: Not provided for this type of submission which relies on non-clinical testing for substantial equivalence. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set requiring expert ground truth for this submission.
4. Adjudication method for the test set: Not applicable, as there was no clinical test set.
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. This device is an orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "No clinical data submitted." For non-clinical tests (like torsional separation), the "ground truth" would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device is an orthopedic implant, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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