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This device is intended for use in total and hemi hip arthroplasty. The device is intended for single, cemented use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

Alpine® Cemented Hip System is comprised of a single piece, conical tapered, collared, femoral hip stem and centralizer designed for single, cemented use. Alpine® Cemented Hip Stem is manufactured from cobalt-chrome alloy (per ASTM F799-11) and Alpine® Centralizer is manufactured from poly(methyl methacrylate), PMMA. See MAF-300, PolyOne Corporation. Device fixation is achieved by cement mantle in the medullary canal.

Alpine® Cemented Hip Stem has a neck with a 12/14 trunnion for modular attachment to femoral heads and is offered in a variety of sizes to accommodate various patient anatomies. Sizes include the following ranges: lengths (114-132mm), horizontal offsets (35-48mm), and vertical offsets (26-30mm), with a resection angle of 40° and a neck angle of 130°.

Alpine® Centralizer is offered in sizes 8mm to 18mm in diameter to accommodate various combinations of stem/centralizer diameters depending on surgeon preference.

This document does not describe an AI/ML powered medical device. It details the Alpine® Cemented Hip System, a medical device for hip replacement surgery. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, and MRMC studies is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and similarities in intended use, design, materials, manufacturing, packaging, and sterilization.

Here's an analysis of the provided information, noting what's present and what's explicitly absent (due to the nature of the device):

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)

• Not applicable. This document pertains to a physical medical device (hip implant) and its mechanical performance testing, not an AI/ML algorithm requiring a test set of data. The "test set" refers to mechanical samples of the device undergoing fatigue and range of motion tests.
• The provenance of data for a mechanical test typically refers to the lab where the testing was performed. This information is not explicitly provided beyond stating the ISO standards.

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 information is for AI/ML performance evaluation. The "ground truth" for a mechanical device is its physical behavior under stress, measured objectively by engineering tests, not by expert consensus on data.

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

• Not applicable. This is for AI/ML evaluation. Mechanical performance tests are objective measurements, not subject to 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. The document explicitly states: "No clinical studies were performed." MRMC studies are used for evaluating diagnostic or interpretive AI/ML systems.

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

• Not applicable. This is not an algorithm.

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

• For the non-clinical tests, the "ground truth" would be the objective measurements of force, cycles, and displacement as defined and specified by the referenced ISO standards (e.g., whether the device fractured or deformed beyond acceptable limits under specified loads). This is determined by the testing methodology itself, not expert consensus on data.

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm. There is no "training set."

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

• Not applicable. There is no "training set" or ground truth for an AI/ML model for this device.

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