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The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:

• Avascular necrosis (Kienboch's disease) .
• Localized osteoarthritic changes
• Long-Standing dislocations .

The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentially the same shape as the native lunate bone. The Lunate implant acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision and to maintain mobility of the wrist. The articular concavity that captures the capitate is more exaggerated to enhance stability. The Lunate implant has two suture holes that allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability while a capsuloligamentous system forms around the implant. The Ascension Pyrocarbon Lunate is constructed of a high strength On-X® PyroCarbon layer deposited on a graphite substrate. The graphite is impregnated with tungsten making the Lunate implant radiopaque. The Ascension Pyrocarbon Lunate is available in 5 sizes for use in left or right applications. Device components are provided sterile in individual packaging.

The provided text describes the 510(k) summary for the Ascension® PyroCarbon Lunate, focusing on its substantial equivalence to predicate devices rather than a detailed study evaluating specific acceptance criteria for performance.

Therefore, many of the requested details about acceptance criteria, device performance metrics, study design, and ground truth establishment are not available in the provided document. The 510(k) process primarily relies on demonstrating substantial equivalence, often through comparison of design, materials, and intended use, along with basic performance testing to ensure safety.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The acceptance criteria for "strength and endurance" are not explicitly quantified in terms of specific thresholds (e.g., specific load, cycles, or failure rates). The document only states that the testing demonstrated they were "adequate to ensure device safety."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The document refers to "performance testing" but does not detail the nature of these tests (e.g., in vitro, animal, human clinical), the number of samples tested, or any patient data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. Given that the performance testing mentioned likely refers to mechanical/material testing for safety and endurance, there wouldn't typically be a "ground truth" established by clinical experts in the same way there would be for a diagnostic AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. Adjudication methods are typically relevant for clinical studies, especially those involving expert interpretation or subjective outcomes. The provided text does not describe clinical studies that would necessitate such methods.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied. This type of study is specific to evaluating diagnostic or assistive AI devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Ascension® PyroCarbon Lunate is a medical implant, not a diagnostic AI device.

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

This question is not applicable as the device is a medical implant, not an algorithm or AI-powered system designed for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing mentioned in the document would likely be engineering standards and specifications for mechanical properties (e.g., strength, endurance limits, material integrity) rather than clinical ground truth (like pathology or outcomes data). The document explicitly states, "These test results demonstrate that the Ascension Lunate's strength and endurance are adequate to ensure device safety." This suggests a comparison against predefined safety thresholds or benchmarks for the material and design.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this device. A training set is used for machine learning models, which is not relevant for this medical implant.

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

This information is not applicable for the same reason as above; there is no training set for this device.

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