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The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.

The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.

Unfortunately, the provided text does not contain information about an AI/ML-based medical device study. The document is an FDA 510(k) clearance letter for the "Freedom Wrist Arthroplasty System," which is a physical medical device (a wrist implant).

The text primarily focuses on:

• Device Description: The components and materials of the wrist implant.
• Intended Use/Indications for Use: What the implant is designed to treat.
• Predicate Device Comparison: How it compares to previously cleared devices.
• Non-Clinical Testing: Specifically, tests related to MRI safety and compatibility (Magnetically Induced Displacement Force, Torque, RF-Induced Heating, Image Artifacts).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or specific performance metrics for an AI/ML device, as this information is not present in the provided document.

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The INTEGRA® Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The INTEGRA® Freedom Wrist Arthroplasty System is intended for cemented use.

The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-constrained implant system designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint. IFW is intended for patients with intractable pain and loss function due to traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis. The system consists of three major components:

• Radial implant made from Cobalt Chromium Molybdenum Alloy (CrCoMo) .
• . Carpal plate - (includes two variable angle screws with locking caps) - made from Titanium Alloy
• . Carpal Poly bearing - made from Ultra-High-Molecular-Weight Polyethylene (UHMWPe)
  Portions of the radial implant and carpal plate have a titanium plasma sprayed coating. The implant system is provided with instrumentation necessary to complete the procedures for which the system is indicated. The components are intended to be implanted together as a system, not individually as hemi-arthroplasty components and are intended for cemented fixation.

The Integra® Freedom Wrist Arthroplasty System is a medical device, and the provided document is a 510(k) summary for its clearance. This summary details non-clinical tests performed to demonstrate substantial equivalence to previously cleared devices. It does not describe a study involving human subjects, AI systems, or the specific criteria typically associated with clinical performance evaluation of an AI/ML device.

Therefore, the requested information components related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this document. This document focuses on the mechanical and material performance of the implant itself.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test, only that the device met them.

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

Not applicable. The tests mentioned are non-clinical (mechanical/material performance) rather than studies on a "test set" of patient data.

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 the context of AI/ML, refers to clinically validated diagnoses or outcomes. These are non-clinical engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in clinical trials or expert review processes for diagnostic accuracy, not physical device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a non-clinical device clearance for a physical implant, not an AI/ML diagnostic or assistive tool.

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

No, a standalone algorithm performance study was not done. This refers to the performance of an AI/ML algorithm without human intervention, which is not relevant to this physical implant.

7. The Type of Ground Truth Used

Not applicable in the AI/ML context. For these non-clinical tests, "ground truth" would be the objectively measured physical properties/performance of the device under specific test conditions (e.g., maximum load bearing before failure, precise wear rates). The standards referenced (ASTM F543, F1160, F1044, F1147, F1978) define the methods for establishing these objective measurements.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML "training set" for this physical device.

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

Not applicable. There is no AI/ML "training set" for this physical device.

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