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The Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The proposed device is comprised of augmented modular glenoid baseplates and modular posts made of the same materials as the predicate (titanium/ BioSync). The baseplates are full wedge augmented versions of the cleared size 24 and size 28 modular baseplates. The posts are offered in lengths ranging from 20 mm to 40 mm. The proposed device is a line extension to the Univers Revers Modular Glenoid System was cleared under K173900.

The provided text describes a 510(k) premarket notification for a medical device, the "Univers Revers Modular Glenoid System (Augmented baseplates)". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific clinical acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.

However, I can extract the relevant information from a mechanical testing perspective, as this is the "performance data" provided for this specific device clearance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Mechanical testing (i.e., Rocking horse testing per ASTM F2028, disengagement testing per ASTM F2009) was performed to demonstrate that the proposed device meets the standards requirements." It also states for endotoxin testing that it "demonstrate[s] that the proposed device meets pyrogen limit specifications," and for MRI that "MRI testing were conducted in accordance with FDA guidance ... and ASTM F2182." The implied acceptance criterion for each is meeting the respective standard/guidance's requirements or specifications, and the device is reported to have met them. The specific quantitative results of these tests and the exact "acceptance values" are not detailed in this summary document.

The subsequent points (2 through 9) primarily apply to studies involving AI algorithms or clinical trials with human readers and ground truth established by experts/pathology. This device, a modular glenoid system, is a physical implant, and its performance evaluation for 510(k) clearance is based on bench testing (mechanical, biocompatibility, MRI safety) and demonstration of substantial equivalence to a predicate device, not clinical performance studies with "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in the way an AI medical device would be evaluated.

Therefore, for aspects related to AI/diagnostic performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples used in bench testing (e.g., glenoid components, constructs for mechanical testing). The provenance of these physical samples is the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biocompatibility testing is established by the specifications of the ASTM, ANSI/AAMI, USP, and EP standards themselves.
4. Adjudication method for the test set: Not applicable. Testing against engineering standards does not typically involve human adjudication in the sense of consensus on diagnostic findings.
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 is a physical implant, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation consists of the established engineering and biological safety standards (e.g., force limits, pyrogen limits, MRI artifact levels) against which the physical device samples were tested.
8. The sample size for the training set: Not applicable. This is a physical implant.
9. How the ground truth for the training set was established: Not applicable. This is a physical implant.

In summary: The provided document is for a medical implant and details bench testing results demonstrating adherence to established engineering and safety standards, rather than clinical performance data against diagnostic accuracy metrics. The entire submission aims to demonstrate substantial equivalence to a previously cleared device.

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