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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. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

The provided document details a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - E1® Humeral Bearings." The focus of the submission is to demonstrate substantial equivalence to a predicate device, K080642, rather than to establish new safety and effectiveness through a comprehensive study meeting specific acceptance criteria as would be typical for an AI/ML device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader studies for a novel AI/ML device is not applicable to this document. This document pertains to a medical device (humeral bearings for shoulder replacement) that is evaluated based on material characteristics and mechanical performance, not an AI/ML algorithm.

However, I can extract information about the non-clinical tests conducted, which serve a similar purpose of demonstrating performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device, not an AI/ML algorithm, the "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device through non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests. Specific numerical acceptance criteria are not explicitly stated as they would be for an AI/ML diagnostic's sensitivity/specificity. Instead, the performance demonstrated that the new device "performed within the intended use" and did not raise new safety or efficacy issues when compared to the predicate.

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated for specific tests, but generally refers to a sufficient number of test articles/specimens to perform the mechanical tests listed (e.g., multiple specimens for tensile strength, impact strength, pull-out, lever-out, and torque-out tests).
• Data provenance: Not explicitly stated, but these are material and mechanical property tests typically conducted in a laboratory setting by the manufacturer (Biomet Manufacturing Corp.) or a qualified testing facility. The data would be prospective to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of mechanical device, "ground truth" is established by adherence to recognized ASTM standards for material and mechanical properties, not by expert consensus on clinical findings. The evaluation is based on scientific and engineering principles.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are for clinical evaluations or subjective assessments, not for objective mechanical property testing against standards.

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 medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

• Non-clinical/Mechanical Performance and Material Standards: The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM D-638 for tensile testing, ASTM F-648 for IZOD impact strength) and the comparative performance against the predicate device.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set."

9. How the ground truth for the training set was established

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" or ground truth for one.

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