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The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:

• Replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
• Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
• Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and
• Failed ulnar head resection.
  It is intended for patient matched use with bone cement and or press-fit fixation.

The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Kapp Patient Matched Ulnar Head Wrist Implant) and details its identification, description, and indications for use, but does not include performance data, study designs, or acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria or quantifiable performance metrics for the Avanta Orthopaedics Wrist implant. Instead, the "study" demonstrating the device meets "acceptance criteria" is a comparison to a predicate device and a general statement about fatigue and wear testing.

Therefore, the table would look like this:

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

The document does not specify a sample size for a "test set" or provide details about data provenance (e.g., country of origin, retrospective/prospective). The "study" mentioned is not a clinical trial with human subjects or a defined test set in the traditional sense of evaluating a diagnostic algorithm. It refers to non-clinical fatigue and wear testing.

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

This information is not applicable as the document describes a medical device (wrist implant) for surgical replacement, not a diagnostic device or algorithm that requires a "ground truth" established by experts in a test set. The validation is based on engineering principles (fatigue, wear) and comparison to an existing predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. There is no mention of a test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not performed, or at least not mentioned. This type of study is typically used for diagnostic imaging devices or algorithms where human readers' performance is evaluated with and without AI assistance. The Avanta Orthopaedics Wrist implant is a physical implant.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed, or not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's functionality is established by engineering tests (fatigue and wear) and comparison to the established performance and safety of the predicate device. There is no mention of pathology, outcomes data, or expert consensus in relation to a "ground truth" for a diagnostic evaluation.

8. Sample Size for the Training Set

There is no mention of a training set. This concept applies to machine learning algorithms. The development of the wrist implant would involve engineering design and material science, not machine learning model training.

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

This information is not applicable as there is no mention of a training set.

Summary of the Study:

The "study" referenced in the document is a regulatory submission process to demonstrate substantial equivalence to an already legally marketed predicate device (Universal Total Wrist System, KMI, K961051). The core of this demonstration relies on:

• Design Characteristics Comparison: Highlighting similarities in product name, use (single use), fixation method (stem in intramedullary canal, screw fixation distally), constraint (semi-constrained), material (Co-Cr/UHMWPE/CPTi), and sizes.
• Indications for Use Comparison: Showing that the Avanta implant has the same indications as the predicate: replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.
• Non-Clinical Testing: A general statement about "Fatigue and wear testing have been performed on this devices to demonstrate substantial equivalence."

Essentially, the "acceptance criteria" appear to be met by demonstrating that the new device is functionally, materially, and geometrically similar to a device already deemed safe and effective, and that it has undergone basic engineering tests (fatigue and wear) to support its durability. The document does not describe a typical clinical trial or a study evaluating diagnostic performance.

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