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The Arthrex 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 Arthrex 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 Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Titanium Glenospheres are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A titanium glenosphere is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The proposed Titanium Glenosphere is manufactured from Ti-6Al-4V ELI per ASTM F136 and will be offered in sizes ranging from 33-42mm. The Titanium Glenospheres are intended to be used with the same components as originally cleared under K173900. The proposed Titanium Glenosphere share the same dimensional specifications to the cleared CoCr Glenospheres (K173900).

This document describes the Arthrex Modular Glenoid System - Titanium Glenosphere, a medical device, and the testing conducted to support its substantial equivalence. As such, the study focuses on engineering performance criteria rather than human reader/AI performance.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance data and general conclusions about the device's equivalence, but it does not specify explicit numerical acceptance criteria for each test. Instead, it indicates that tests were conducted to evaluate properties and that the device meets specifications or is substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "Fatigue testing and push-out testing were conducted," and "an engineering analysis was performed." For these types of mechanical tests, sample sizes are typically determined by relevant ISO standards or internal validation protocols. The exact number of parts tested is not provided.
• Data Provenance: The studies are described as "Performance Data" and "non-clinical data," which typically refers to laboratory or bench testing. The origin of the data is implicitly from Arthrex Inc.'s internal testing or a contract testing laboratory, rather than patient data from a specific country. This is retrospective in the sense that the tests were completed before submission, but not derived from an existing patient dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device submission. The tests are mechanical and material property tests, not diagnostic imaging or clinical assessment studies that would require human expert ground truth. The "ground truth" here is established by the physical and chemical properties of the materials and the mechanical performance of the device under defined conditions, measured by instrumentation and validated test methods.

4. Adjudication Method for the Test Set

This is not applicable. As stated above, this is not a study requiring human adjudication of clinical outcomes or images. The "adjudication" in this context would be the review and approval of the test methods, raw data, and final reports by qualified engineers and quality personnel within Arthrex and by the FDA.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

This is not applicable. The device is an orthopedic implant (shoulder glenosphere), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering and material specifications from recognized standards (e.g., ASTM F136 for the material, EP 2.6.14/USP for bacterial endotoxin) and the established performance of the predicate device (K173900). The goal is to demonstrate that the new device's properties and performance meet predefined mechanical and biological safety criteria and are substantially equivalent to the cleared predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an orthopedic implant's mechanical testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

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The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

The Arthrex Eclipse Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The proposed Eclipse Titanium humeral head is manufactured from Ti-6Al-4V ELI per ASTM F136 and is offered in sizes ranging from 37-55mm with varying offsets of 16-23mm. The humeral head is placed on a trunnion, which is fixated to the proximal humerus by a hollow screw. The Titanium humeral heads are used with the existing trunnions and hollow screws cleared under the predicate.

This FDA 510(k) summary describes a medical device, the Arthrex Eclipse Titanium Humeral Head, which is a shoulder prosthesis. However, it does not contain information about the acceptance criteria and study proving a software or AI-based device's performance.

The document pertains to a physical orthopedic implant. The "Performance Data" section discusses:

• Fatigue testing and Pull Off testing: Evaluates the mechanical properties of the humeral head.
• Engineering analysis: Compares hardness, adhesion, surface roughness, scratch resistance, and Young's modulus to the predicate device.
• Bacterial endotoxin testing: Ensures pyrogen limits are met.
• MRI compatibility engineering analysis: Addresses MRI force, torque, and image artifact.

These are all standard tests for physical medical implants and not for software or AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device (as in, a software or AI device) meets critical performance measures from the provided text.

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