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The Press-fit Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used in a press fit mode.

The femoral stem is straight. The proximal body is trapezoidal in cross-sectional geomety. A Morse type taper is used to receive modular heads. The Press-Fit is fabricated from wrought Ti-6A1-4V. The entire stem is grit blasted. The stem is available in eight sizes.

This document is a 510(k) premarket notification for a medical device called the "Press-Fit Stem," a component of a hip replacement system. It is submitted to the FDA for review and approval to market the device. The document states that the device is substantially equivalent to existing predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and associated studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there is no specific table of acceptance criteria or detailed performance metrics that would typically be associated with a clinical study for a new medical device. The document primarily focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk devices.

The "Test Results" section is very brief and general:

Important Note: For a 510(k) submission like this, the "acceptance criteria" are largely centered on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often relies on similarity in design, materials, manufacturing processes, and sometimes some bench testing, rather than extensive clinical efficacy trials typically seen for novel, high-risk devices. The details of the "FEA fatigue analysis" and "testing on the Morse type taper" are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

The provided text does not describe a clinical "test set" or human subject data. The "Test Results" specifically mention:

• FEA fatigue analysis: This is a computational simulation (Finite Element Analysis), not a test on human subjects or even physical devices in a clinical setting. There is no "sample size" in the traditional sense, as it involves computer modeling.
• Testing on the Morse type taper: This refers to bench testing (laboratory testing) of the mechanical interface between the stem and the modular head. The sample size for this bench test is not mentioned in the document.

Therefore, there is no data provenance (country of origin, retrospective/prospective) for a test set involving human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since there is no human subject "test set" described, there is no mention of experts establishing a ground truth in this context. The evaluation described is mechanical/computational.

4. Adjudication Method for the Test Set:

Not applicable, as no human subject "test set" is described for which adjudication would be necessary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers (e.g., radiologists) interpreting medical images or data, with and without AI assistance, to assess the impact of AI on their performance. The described "tests" are mechanical and computational.

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

This question is not directly applicable to the device described. The "Press-Fit Stem" is a physical orthopedic implant, not a software algorithm or an AI-powered diagnostic tool. The "FEA fatigue analysis" could be considered a standalone computational assessment, but it's not an "algorithm" in the typical sense of AI.

7. The Type of Ground Truth Used:

For the mechanical testing (FEA fatigue, taper testing), the "ground truth" would be established by:

• Engineering principles and material science standards for fatigue life.
• Industry-recognized mechanical testing standards (e.g., ISO standards for orthopedic implants) for taper integrity.

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in the reported "Test Results."

8. The Sample Size for the Training Set:

This question is not applicable. The Press-Fit Stem is a physical device, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI model.

In summary: This 510(k) submission relies on demonstrating substantial equivalence to predicate devices primarily through similarity in design, materials, and intended use, supported by basic mechanical and computational testing. It does not involve human subject trials, AI algorithms, or extensive clinical performance data typically associated with your questions.

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