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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 Baseblate 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 is a 510(k) premarket notification for a medical device called the "Comprehensive® Reverse Shoulder Humeral Tray." It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. This type of document focuses on mechanical and material testing to show that the new device performs similarly to an already approved device, rather than conducting a study to prove a device meets specific clinical acceptance criteria in terms of diagnostic accuracy or therapeutic outcome.

Therefore, the information requested in the prompt, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets (in a clinical context), ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not applicable to this document. This document describes the physical and material characteristics of an orthopedic implant and its non-clinical performance (e.g., fatigue strength, material properties).

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria for diagnostic or therapeutic performance as would be relevant for an AI/algorithm-based device. Instead, it details mechanical performance comparisons to a predicate device.

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

• Test Set Sample Size: Not applicable. The "tests" here refer to mechanical and material testing, not clinical data or diagnostic test sets.
• Data Provenance: Not applicable in the context of clinical data. The tests performed are laboratory-based mechanical and material characterization.

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

• Not applicable. "Ground truth" in this context would refer to material and mechanical standards defined by organizations like ASTM, not expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. No clinical adjudication was performed.

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 not an AI/algorithm-based device. 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 (shoulder implant), not an algorithm or AI.

7. The type of ground truth used

• For mechanical and material properties: Industry standards (e.g., ASTM F-648) are used to define acceptable material performance. The comparison to a legally marketed predicate device also serves as a "ground truth" for substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device and does not involve training data.

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

• Not applicable.

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