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Non-cemented total joint replacement in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty

The X-Series Integral® RPP Femoral Components are identical to the predicate X-Series Integral® Femoral components in overall design. The X-Series Integral® RPP Femoral Components have a reduced proximal geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136.

The provided document is a 510(k) summary for a medical device (X-Series Integral® RPP Hip Femoral Components). It describes a submission made to the FDA for market clearance, focusing on substantial equivalence to a predicate device.

Crucially, this document specifies "Clinical Testing: None provided" and "Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device."

Therefore, the following information regarding acceptance criteria and studies demonstrating that the device meets those criteria is largely not applicable (N/A) in the context of the provided text, as this type of 510(k) submission primarily relies on substantial equivalence and non-clinical data for a modified device, rather than new clinical trials with specified acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown based on your request, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are inferred from the 510(k) approach, which aims for substantial equivalence to a predicate device. The primary "performance" demonstrated is that the design changes (reduced proximal geometry) do not negatively impact safety or core functionality compared to the legally marketed predicate. No specific quantitative, clinical performance metrics (like survival rates, range of motion, pain reduction scores) are listed as acceptance criteria or reported for this device in this summary, as these would typically be established for a new device or in a PMA application.

Details of the Study/Evidence Provided:

Since no clinical study demonstrating specific performance metrics for this device was performed or provided, many of your requested points are Not Applicable or Not Provided by the document.

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

• Sample size: Not applicable. No clinical test set used.
• Data Provenance: Not applicable.
• The non-clinical testing involved "Finite Element Analysis and engineering analysis." The "test set" for these would be the computer models and engineering calculations, not biological samples. Specifics of these analyses (e.g., number of FEA models, range of loads tested) are not provided.

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. No human experts were involved in establishing a ground truth for a clinical test set for this 510(k) submission. Engineering experts would have been involved in performing and reviewing the Finite Element Analysis and engineering analysis, but their number and qualifications are not specified in this summary.

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

• Not applicable. No adjudication method for a test set was used, as no clinical test set was required or presented for this 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

• Not applicable. This device is a hip femoral component, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a hip femoral component. The "performance" assessment was primarily through non-clinical engineering analysis, not an algorithm.

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

• For the non-clinical testing (Finite Element Analysis and engineering analysis), the "ground truth" would be based on principles of mechanical engineering, material science, and possibly established biomechanical safety thresholds. No clinical ground truth (like pathology or outcomes data) was used for this specific device's testing. The substantial equivalence relies on the predicate device's established clinical ground truth.

8. The sample size for the training set

• Not applicable. No training set was used, as there was no algorithm or machine learning component.

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

• Not applicable. No training set was used.

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