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The PROFEMUR® Z Classic Stems are indicated 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® Z Classic 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 add a monolithic femoral neck option to the PROFEMUR® Z Hip System. The PROFEMUR® Z Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Z Classic Stems are available in 9 sizes (1-9) and are available in two surface finish options: gritblast or titanium plasma spray conforming to ASTM F1580. Each size is available with either a long or short fixed femoral neck and all sizes are available in two neck offset options, Standard (neutral) and Extended (varus). The surface finish options, neck lengths, and neck offset are designed to create options identical to those available with the predicate modular devices.

The provided text describes the PROFEMUR® Z Classic Stems and a special 510(k) submission. It focuses on the comparison of the new device to predicate devices for substantial equivalence, primarily through nonclinical testing.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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 explicitly states: "Clinical data was not provided for the subject devices."
Therefore, there is no test set of clinical data for human performance, and thus no information on sample size or data provenance in that regard. The "test set" here refers to the physical devices undergoing nonclinical testing. The sample sizes for these physical tests are not specified in the document.

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. This device is an orthopedic implant, and the ground truth for its performance is established through engineering and biomechanical testing (nonclinical), not expert interpretation of clinical data in the way medical imaging devices might require.

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

Not applicable. As noted above, the "test set" refers to physical devices undergoing nonclinical testing, not clinical cases requiring expert adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This document pertains to a hip stem implant, which does not involve human readers interpreting AI output.

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

Not applicable. This is not an AI algorithm or a diagnostic device. The "standalone" performance here refers to the physical device's mechanical integrity and range of motion, which was evaluated through nonclinical testing as described in section (b)(1).

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

The ground truth for the device's performance is based on:

• Engineering specifications and standards: Adherence to ISO 7206-4, 6, and 8 for fatigue tests, and ISO 21535 for range of motion.
• Manufacturer specifications: Conformity to Wright Medical Technology (WMT) specifications for the titanium plasma spray coating, and comparison to predicate device material and design characteristics (ASTM F620 for titanium alloy).
• Vendor Master File: Verification of the titanium plasma spray coating through testing summarized in a vendor Master File.

8. The sample size for the training set

Not applicable. The document explicitly states "Clinical data was not provided for the subject devices." There is no mention of an AI model or a training set for an algorithm.

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

Not applicable, as there is no training set for an AI algorithm mentioned in the document.

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