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The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.

The Longevity Integrated Taper (IT) Constrained Liner is a modular acetabular shell liner intended to capture the femoral head of a total hip prosthesis to reduce the incidence of joint dislocation. The liners feature integral polyethylene "fingers" reinforced with a modular Tivanium® ring to capture the mating femoral head. The Longevity IT Constrained Liners are intended to mate with Continuum and Trilogy IT acetabular shells.

The provided text is a 510(k) summary for a medical device, the Longevity® IT Highly Crosslinked Polyethylene Constrained Liner. It details the device's description, intended use, and substantial equivalence to predicate devices, supported by non-clinical performance data.

Here's an analysis of the document for the requested information:

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

The document states that "Non-Clinical testing was conducted on the proposed device per FDA's Guidance Document, "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis". This testing demonstrated that the Longevity IT Constrained Liners performed as intended and met all acceptance criteria."

However, the specific quantitative acceptance criteria (e.g., minimum load for pull-out, maximum displacement, etc.) and the precise reported device performance values for each test are not explicitly listed in this summary. The summary only names the types of tests performed.

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

The document describes non-clinical performance testing. This refers to laboratory-based mechanical and materials testing of the device, not clinical data involving human subjects. Therefore, the concepts of "test set sample size," "country of origin," "retrospective or prospective" for human patient data are not applicable here. The testing was conducted on samples of the device itself. The specific number of devices tested for each non-clinical test is not specified in this summary.

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 question is not applicable to this submission. The "ground truth" in this context is established by engineering standards and FDA guidance for device performance, not by expert interpretation of patient data.

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

This question is not applicable as it pertains to clinical studies involving human subject data requiring adjudication, which was not performed for this 510(k) submission.

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 question is not applicable as no clinical efficacy or comparative effectiveness study involving human readers or AI was conducted or reported in this 510(k) summary. The submission is based on non-clinical performance data for a mechanical implant.

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

This question is not applicable as this device is a mechanical implant and does not involve an algorithm or AI.

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

For the non-clinical performance testing, the "ground truth" is defined by established engineering and biomechanical principles, industry standards, and the specific test methodologies outlined in the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." The compliance with these defined performance requirements constitutes the "ground truth" for the device's safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the reasons stated above.

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