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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications

Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.

The provided document is a 510(k) Summary for a medical device (ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads). It describes the device, its intended use, and claims substantial equivalence to predicate devices. Crucially, it states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, a study proving the device meets acceptance criteria as typically understood for AI/diagnostic devices (e.g., performance metrics, ground truth, expert adjudication, MRMC studies) was not conducted for this submission, as it is a medical device, not a diagnostic or AI product.

However, given the request's structure which assumes such a study, I can only extract information related to "Non-Clinical Testing" which serves a similar purpose of validating the device.

Here's a breakdown based on the provided text, primarily addressing the "Non-Clinical Testing" section since clinical trials were not performed.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document does not specify the exact "standards or guidelines" or quantitative performance metrics, only that they were met or exceeded.)

2. Sample size used for the test set and the data provenance

The document does not detail specific sample sizes for non-clinical testing. It simply states "Verification activities were performed on ArComXL™ liners." There is no mention of a "test set" in the context of clinical or diagnostic data, as this is a physical medical implant. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic study.

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

This section is not applicable. Since no clinical or diagnostic study was performed, there was no "ground truth" to establish in the context of expert review of data/images. The "ground truth" for non-clinical testing of a physical implant would typically involve engineering specifications, material properties, and mechanical test results against established benchmarks or regulatory standards, which are not detailed here.

4. Adjudication method for the test set

This section is not applicable. No test set requiring adjudication by experts was utilized as no clinical or diagnostic study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This section is not applicable. The device is a physical medical implant (hip replacement components), not an algorithm or AI product.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be related to engineering specifications, material science properties, and established regulatory/industry standards for medical implants (e.g., ASTM F-648 for UHMWPE). The document confirms that the device characteristics were "identical to the predicate (K042051)" and met "current standards or guidelines."

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/algorithm for this device.

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

This section is not applicable. There is no "training set" or corresponding ground truth establishment in the context of an AI/algorithm for this device. The "ground truth" for the manufacturing materials and processes would be based on validated scientific and engineering principles and quality control measures.

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