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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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size (e.g., number of inserts or material samples). Instead, it refers to "ArComXL™ polyethylene acetabular inserts" and "predicate polyethylene liners/material."

• Sample Size: Not explicitly stated as a numerical count beyond referring to "ArComXL™ polyethylene acetabular inserts" or "material" for each test. For the Hip Simulator Wear, it states "All inserts in this study mate with either a 50 or 52mm acetabular shell...", implying multiple samples were tested for each group (ArComXL™ and predicate).
• Data Provenance: The studies are in vitro laboratory tests. There is no mention of data country of origin or whether it's retrospective/prospective, as this is not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for these material science tests is established through objective physical measurements using standardized testing methods (e.g., ASTM standards, hip simulator protocols), not subjective expert assessment. The free radical testing was performed by "an independent laboratory."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance assessments, not for material property testing. The results are quantitative measurements.

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 material science study evaluating the physical properties of a polyethylene liner for hip implants, not a diagnostic device involving human readers or AI assistance.

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

Yes, all presented studies are standalone physical performance tests of the device material itself, without human intervention in the device's functional performance or a human-in-the-loop element during testing.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Physical Measurements and Mechanical Testing: Volumetric wear rate (mm³/10⁶ cycles), number of free radicals (spins/g), oxidation index (FTIR), ultimate tensile strength (MPa), and ultimate load (N) are objective, quantitative physical properties measured according to established protocols or ASTM standards.
• Established Standards: ASTM F-648 for UHMWPE, ASTM F2003-00 for accelerated aging, ASTM F2183-02 for small punch testing, and ASTM D638-02a for tensile testing.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device. These are material tests of manufactured components.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set mentioned or relevant for this type of device and study.

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