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The indications for use for total hip arthroplasty include:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity;
• 4. Revision procedures where other treatments or devices have failed; and,
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

6. Dislocation risks
   MDM Liners are intended for cementless use only.

The subject device is an MDM X3 Insert with an inner diameter of 28mm and outer diameter of 38mm. It is a sterile, single-use device that will articulate within the inner surface of the highly polished cobalt chrome MDM Liner and will be compatible with 28mm Howmedica Osteonics femoral heads. The subject device is compatible with the same liners, cups, and femoral stems as the previously cleared Stryker dual mobility hip systems. The polyethylene MDM X3 Insert and femoral head combine to create the dual mobility bearing. The subject MDM X3 Insert is manufactured from sequentially crosslinked and annealed polyethylene, known as X3. The resin used is Type 1 (GUR 1020) which meets the requirements of ASTM F648.

The provided text is a 510(k) summary for a medical device: "28mm/38D MDM X3 Insert for MDM Liner," which is a component of a total hip arthroplasty system. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a device meets specific acceptance criteria through a standalone study of a new type of device, especially concerning AI/Software performance.

Therefore, the information requested in your prompt regarding acceptance criteria, a study proving device performance (especially relating to AI or a "test set" and "ground truth"), sample sizes for test and training sets, expert involvement, and MRMC studies, is not present in this document.

This 510(k) summary explains that non-clinical testing (material testing, biocompatibility, sterilization validation, mechanical testing like wear, fatigue, range of motion, dislocation resistance, and MRI safety testing) was performed to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required as a basis to demonstrate substantial equivalence.

To answer your prompt directly based on the provided text:

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

• Not Applicable. The document describes non-clinical engineering and material performance tests for substantial equivalence, not acceptance criteria for a novel AI/software-based device. The specific quantitative results of these tests and their corresponding acceptance limits are not detailed in this summary. It only lists the types of tests performed.

2. Sample sizes used for the test set and the data provenance:

• Not Applicable. This is not an AI/software device. The document does not describe a "test set" in the context of data for algorithms. For the non-clinical tests listed (e.g., wear testing, fatigue), the sample sizes are not explicitly mentioned in this summary but would typically be prescribed by relevant standards (e.g., ASTM, ISO).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is not an AI/software device that requires expert-established ground truth from a test set (e.g., radiological reads).

4. Adjudication method for the test set:

• Not Applicable.

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 is a physical orthopedic implant component, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable.

7. The type of ground truth used:

• Not Applicable. For a physical implant, "ground truth" typically refers to engineering specifications, material properties, and mechanical performance under defined test conditions, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable. This is not an AI/software device that involves a training set.

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

• Not Applicable.

In summary, the provided FDA 510(k) summary is for a physical medical device (an orthopedic implant component) and discusses demonstration of substantial equivalence through non-clinical testing, not the performance evaluation of an AI/software device against specific acceptance criteria as you've outlined in your prompt.

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