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The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions;

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
   4, revision procedures where other treatments or devices have failed
   The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

The purpose of this submission is to provide additional sizing options for the predicate PROFEMUR® Preserve Hip Stems (K112080) by adding a line extension. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are modular stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are available in three configurations and are coated with titanium plasma spray conforming to ASTM F1580.

The provided document is a 510(k) Pre-market Notification for the PROFEMUR® Preserve Sizes 1-3 Hip Stems. It details the device's substantial equivalence to a predicate device and includes information on nonclinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify the exact sample sizes (number of devices tested) for the nonclinical tests (proximal fatigue, distal fatigue, range of motion). The studies were nonclinical (laboratory-based mechanical testing), not human clinical studies, so provenance in terms of country of origin or retrospective/prospective is not applicable.

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" for the nonclinical testing of a hip stem involves established engineering and materials science standards (ISO, ASTM). The "experts" in this context would be the engineers and technicians performing the tests and comparing results against the specified standards. Their qualifications are inherent in their ability to conduct these specific standardized tests. No medical experts (like radiologists) were involved in establishing "ground truth" for this type of device.

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

This question is not applicable to the nonclinical engineering tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretation or classification by multiple experts is required for establishing ground truth, especially in image analysis or disease diagnosis. For mechanical testing, the results are objective measurements against defined pass/fail criteria in the standards.

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:

No MRMC comparative effectiveness study was done. This type of study is relevant for devices involving human interpretation of data, often with AI assistance (e.g., AI for radiology). The PROFEMUR® Preserve Sizes 1-3 Hip Stems are a mechanical implant, and the testing described is nonclinical mechanical testing, not a study of human reader performance.

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

No standalone (algorithm only) performance study was done. This type of study is relevant for AI/software devices. The device is a physical hip stem, and its performance is evaluated through mechanical bench testing, not algorithmic performance.

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

The "ground truth" for the nonclinical testing of the PROFEMUR® Preserve Sizes 1-3 Hip Stems was established by recognized international and national standards for orthopedic implants. Specifically:

• ISO 7206-4 for proximal fatigue.
• ASTM F2068 for distal fatigue.
• ISO 21535 for range of motion.

These standards define the test methodologies and acceptance criteria (e.g., number of cycles survived at a certain load without failure) against which the device's performance is measured.

8. The sample size for the training set:

This question is not applicable. There was no "training set" as this device is a mechanical implant subjected to nonclinical testing, not a machine learning or AI algorithm that requires training data.

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

This question is not applicable as there was no training set.

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