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Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Osteonics® Crossfire™ Polyethylene Acetabular Components consist of the following devices: Osteonics® Omnifit® 10° Cup Insert - Series II (2041C); Osteonics® Omnifit® 20° Cup Insert - Series II (2042C); Osteonics® Omnifit® 0° Cup Insert - Series II (2043C); Osteonics® Omnifit® Eccentric 10° Cup Insert (S2301C); Osteonics® Omnifit® Eccentric 20° Cup Insert (S2302C).

This document describes the acceptance criteria and the study conducted for the Osteonics® Polyethylene Acetabular Components.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is described in terms of "wear claims," which effectively serve as the acceptance criteria for the new Crossfire™ polyethylene material compared to the standard polyethylene.

2. Sample Size and Data Provenance

• Test Set (Wear Claims): The studies were in vitro hip wear simulator tests. The sample size for each test condition (unaged, aged, abrasive) is not explicitly stated as a number of devices, but rather as "The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850" implying a specific model was tested. It doesn't specify how many individual units of this model were tested in each condition.
• Data Provenance: The data is from in vitro laboratory testing using a hip wear simulator. The studies were conducted by Osteonics Corporation as part of their premarket notification. The country of origin is not explicitly stated beyond "Osteonics Corporation" which is located in Allendale, NJ, USA. The data is prospective in the sense that the tests were performed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• This device is a medical implant, and the ground truth for its performance (wear claims) is established through objective, laboratory-based in vitro testing, not through expert review of clinical cases. Therefore, the concept of "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable here. The "ground truth" is the measured wear rate under controlled experimental conditions.

4. Adjudication Method for the Test Set

• Not applicable. As described above, the ground truth is established through physical measurements in a laboratory setting, not through human interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The device in question is a physical implant, and its performance is evaluated through in vitro wear testing.

6. Standalone Performance (Algorithm Only)

• Not applicable. This device is not an algorithm or software. It is a physical medical implant. The performance described is inherent to the material properties and design of the implant itself, tested in a standalone in vitro setting.

7. Type of Ground Truth Used

• The ground truth for the device performance (wear claims) is based on objective in vitro experimental data and quantitative measurements (gravimetric wear rate) obtained from multiaxial hip joint simulation tests.

8. Sample Size for the Training Set

• Not applicable. This submission concerns a physical medical device (polyethylene acetabular components), not a machine learning model. Therefore, there is no "training set." The material itself is a product of manufacturing processes, and its properties are inherently defined by those processes, not by training on data.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device.

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