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The H-Max S stems are indicated for use in total hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• · non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• · rheumatoid arthritis;
• · treatment of femoral head and neck fractures;
• · revisions in cases of good remaining femoral bone stock.

The H-MAX S femoral system consists of the H-MAX S femoral stem, a femoral head and an acetabular cup. The H-Max S Stems are intended for use with CoCrMo femoral heads and Limacorporate Cemented cups.

The H-MAX S femoral stem is a monolithic cementless stem made from Ti6Al4V (ISO 5832-3, ASTM F1472). The external surface has a macro-roughened surface. A layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations (standard and lateralizing) that vary in the CCD angle.

The provided document (K112091) is a 510(k) premarket notification for a medical device, the H-MAX S femoral hip system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance measures.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points can be made based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document describes mechanical testing performed, but it does not specify quantitative acceptance criteria or report specific performance values against such criteria. For example, it mentions "fatigue testing to demonstrate the strength" and "pull-off testing to demonstrate the strength of the taper connection," but not what specific load or cycle count was deemed acceptable.

2. Sample size used for the test set and the data provenance: This information is not present. The document states "All mechanical testing was done on worst case components or constructs," but it does not provide details on the number of samples tested or the origin of any materials other than that the device is manufactured by Limacorporate S.p.A. in Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there was no clinical study described that would require expert-established ground truth. The testing was mechanical.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.

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 implant, not an AI-assisted diagnostic tool, and no clinical studies involving human readers or AI were performed or described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the engineering specifications and recognized test standards (e.g., ISO, ASTM), which the device aimed to meet. The document states, "Where possible, standard test methods were used to allow comparison to testing of the predicate devices."

8. The sample size for the training set: Not applicable. No clinical or AI-related training set was involved in this submission.

9. How the ground truth for the training set was established: Not applicable. No training set was involved.

Summary from the document:

The manufacturer performed non-clinical mechanical testing to demonstrate the substantial equivalence of the H-MAX S femoral hip system to predicate devices (specifically the Depuy Corail AMT Femoral stem). This testing included:

• Fatigue testing on the femoral stem and neck.
• Pull-off testing for the taper connection.
• Simulation of the Range of Motion.
• Characterization of the Hydroxyapatite coating according to FDA guidance.

The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the H-MAX S femoral hip system to the predicate devices." This is a key point for 510(k) submissions where the device is deemed substantially equivalent based on similarities in intended use, indications, design, materials, and non-clinical performance to an already legally marketed device.

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