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1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
2. Revision of failed femoral head replacements.
3. When alternative reconstructive techniques are not viable.
4. When arthrodesis is contraindicated.
5. Avascular necrosis or fracture of the femoral head.
6. Congenital defects that will allow adequate function of the system.

The 26 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.

This document is a 510(k) summary for a medical device (26 mm Cast CoCr Head and Polyethylene Acetabular Shell Liner) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically seen for a diagnostic or AI-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to existing devices, which is a different regulatory pathway. The "studies" mentioned are performance tests, but they are not presented as typical clinical trials with acceptance criteria and statistical analyses of performance metrics like sensitivity or specificity.

Here's an analysis based on the provided text, highlighting why the requested information for acceptance criteria and a detailed study is not present:

The 510(k) summary focuses on the materials and size modification of an existing hip replacement component. The primary "proof" of its safety and effectiveness, in this regulatory context, comes from:

• Established Biocompatibility: The materials (Co-Cr-Mo alloy and UHMWPE) are stated to be "biocompatible" and "in current use in numerous hip systems," with "many years of successful clinical application." This is a qualitative reference to past performance rather than a specific study within this submission.
• Prior 510(k) Submissions: "Fatigue testing of the stem and 26 mm head was satisfied under previously released 510(k) submissions." Similarly, "the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed." This indicates that the critical performance tests (like fatigue) were conducted and passed for the predicate device, and the current device (with a size change) is considered to meet those same criteria by virtue of its similarity and established performance of the components.

Therefore, the requested information cannot be fully provided from this document. However, I can extract what is implicitly or explicitly stated about the type of assessment conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This document does not provide specific sample sizes for tests. It refers to tests being "satisfied under previously released 510(k) submissions." The data provenance for any mentioned tests (e.g., fatigue testing) is not specified, but usually, such tests are conducted in a laboratory setting. There is no indication of retrospective or prospective clinical human data for this specific submission; instead, it relies on the clinical history of the materials and predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For mechanical testing (like fatigue), ground truth is established by test standards and physical measurements, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set
This information is not applicable and not provided. Mechanical tests do not typically involve adjudication.

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
This information is not applicable and not provided. This is a medical implant, not an AI-driven diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is a medical implant, not an algorithm.

7. The type of ground truth used
For the mechanical performance (e.g., fatigue testing), the "ground truth" would be established by physical measurements against ISO or ASTM standards for orthopedic implants. For the material biocompatibility, the "ground truth" relies on historical clinical evidence and generally accepted scientific principles for the specified materials. There is no pathology or outcomes data specifically generated for this submission detailed here.

8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.

9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.

In summary: The provided text is a regulatory submission demonstrating substantial equivalence for a medical implant, rather than a clinical study report for a diagnostic device (especially an AI-driven one). The "proof" of performance relies on established materials, prior testing of predicate devices, and meeting design objectives.

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