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

The ArComXLTM polyethylene liners are manufactured from highly cross-linked polyethylene conforming to ASTM F648 that was previously cleared in K042051. ArComXLTM is available in three designs: MaxRom, Hi-Wall, and 10o. Biolox® delta Ceramic Heads (K042091) are composed of Transition-Toughened-Platelet-Alumina (TTPA). The highly polished spherical surface articulates with the ArComXLTM polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper.

This document describes the 510(k) premarket notification for the ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this document is a regulatory submission for a traditional medical device (hip joint prostheses) that relies on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned, "Volumetric wear testing," is a non-clinical test performed to support this substantial equivalence.

Therefore, many of the requested fields related to AI/ML device studies, ground truth, and expert evaluation cannot be filled from the provided text.

Here is an attempt to answer the questions based only on the provided text, with many fields noted as "Not applicable" or "Not provided" due to the nature of the document:

1. Table of acceptance criteria and the reported device performance

Explanation: For traditional medical devices like this, acceptance criteria typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through non-clinical testing and comparison of design and materials rather than explicit quantitative clinical performance metrics against pre-defined acceptance thresholds in the way an AI/ML study would. The key acceptance is the FDA's finding of "substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of an AI/ML study. For the volumetric wear testing, the sample size of liners/heads tested is not specified.
• Data Provenance: Not applicable for an AI/ML study. The wear testing is a laboratory-based non-clinical study. Country of origin of the data is not specified (though Biomet is based in the US). Retrospective or prospective does not apply to a pre-clinical bench test.

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 a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from patient data. The "ground truth" for wear testing is the measured volumetric wear.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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. An MRMC study was not done as this is not an AI/ML device impacting human reader performance.
• Effect size: Not applicable.

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

• Not applicable, as this is not an AI/ML algorithm.

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

• For the non-clinical volumetric wear testing, the "ground truth" is derived from physical measurements of material loss post-wear simulation. This is a physical measurement-based ground truth.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not an AI/ML algorithm.

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

• Not applicable. This device does not involve a training set.

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1. Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck 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 modifying the manufacturing process of UHMWPE used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene, that Biomet will herein refer to as ArComXL™.

The provided document describes the ArComXL™ Polyethylene Liners and studies conducted to demonstrate their performance compared to a predicate device. The information is extracted from a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining explicit "acceptance criteria" in the same way one might for a new, novel product with performance goals.

However, we can infer the acceptance criteria from the reported performance improvements over the predicate device. The studies are standalone (algorithm only, no human-in-the-loop performance is relevant here as it's a material science evaluation). The ground truth is based on physical material testing and established ASTM standards, not expert consensus or clinical outcomes.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Note: "Acceptance Criteria" are inferred as improved performance over the predicate device, as this is a 510(k) submission for a modification to an existing device. The goal is to show the new device is "substantially equivalent" or better.

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