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The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is obesigned to be cemented into the acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

The subject Trident® All Poly Cups are polyethylene acetabular components that are intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. The subject device is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

The subject Trident® All Poly Cup is available in Crossfire™ UHMWPE with a tantalum bead radiographic marker. The predicate device is also manufactured from Crossfire™ UHMWPE; however, the radiographic marker is a cobalt chromium alloy bead. The Crossfire™ UHMWPE material conforms to ASTM F-648. The radiographic marker of the subject device complies with ASTM standard F-560 while the radiographic marker for the predicate device conforms to ASTM F-1377.

This document is a 510(k) summary for a medical device modification, specifically for the Trident® All Poly Cup. It does not contain information about a study that assesses device performance against acceptance criteria in the way described in the request.

The 510(k) submission is for a material modification to the radiographic marker of the Trident® All Poly Cup. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance against acceptance criteria through a clinical trial or extensive standalone/comparative effectiveness studies as would be done for novel devices or those requiring a PMA.

Therefore, most of the information requested cannot be extracted from the provided text. The document focuses on regulatory approval based on material equivalence, not on a detailed performance study with human subjects, AI systems, or extensive statistical analysis.

However, I can extract the following limited information:

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

This document does not specify formal "acceptance criteria" and "reported device performance" in the context of a clinical or in-vitro study. Instead, the focus is on material conformance for regulatory purposes.

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

Not applicable. This document describes a regulatory submission based on material equivalence, not a test set for performance evaluation. No human subject data (prospective or retrospective) is mentioned.

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):

Not applicable. There is no mention of a test set with ground truth established by experts.

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

Not applicable. There is no mention of a test set or 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:

Not applicable. This is not an AI-enabled device and no MRMC study is mentioned.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "ground truth" in this context is adherence to material standards (ASTM F-560, ASTM F-648) and demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, manufacturing, intended use, packaging, and sterilization.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI system.

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

Not applicable.

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