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The Rejuvenate™ Modular Hip is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available Howmedica Osteonics acctabular components, V40 femoral heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.

The indications for use of total hip replacement prostheses include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This hip is intended for cementless use only.

This Special 510(k) submission is a line extension to address modifications to the Rejuvenate™ Modular Hip System. This line extension extends the combined head/neck length options.

This is a 510(k) premarket notification for a hip prosthesis, Rejuvenate™ Modular Hip System. The provided text is a summary of safety and effectiveness. It describes a medical device, not an AI/ML powered device, therefore, a study that proves the device meets the acceptance criteria is not applicable in the typical sense of AI/ML performance metrics.

The submission establishes substantial equivalence to existing predicate devices based on intended use, design, materials, and operational principles, rather than performance against specific acceptance criteria derived from a clinical or diagnostic study with a test set, ground truth, and human reader comparisons.

Therefore, many of your requested points are not relevant to this type of regulatory submission. I will address the relevant points and indicate where information is not available or applicable.

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

For this medical device (a hip prosthesis), "acceptance criteria" are not defined as performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML diagnostic. Instead, the acceptance criteria are met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context refers to the device's characteristics (design, materials, intended use, indications) that are compared to the predicate.

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 is not an AI/ML study involving a test set of data. The submission relies on comparative analysis with predicate devices and possibly bench testing (though not detailed in this summary) to demonstrate substantial equivalence for a physical medical implant.

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 "ground truth" establishment in the context of a diagnostic test for this type of medical device submission.

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

Not applicable.

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-assisted device.

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

Not applicable.

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

Not applicable. The "truth" in this context is established by the safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML product developed with a training set.

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

Not applicable.

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