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The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid . arthritis, post-traumatic arthritis, or late stage avascular necrosis.
• Revision of previous failed 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 is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.

The existing Trident® Polyethylene Acetabular System features acetabular liners in neutral, hooded, eccentric and elevated rim versions. The subject Trident® Crossfire® Polyethylene Liners are an addition to the existing liners (standard and eccentric versions). The subject liners will be offered in fourteen new sizes which include the addition of a 36mm size eccentric liner in both 0° and 10° versions and 26mm, 28mm, 32mm and 36mm size standard liners in both 0° and 10° versions in the same polyethylene thicknesses as the Trident® Elevated Rim Liners. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.

The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria in terms of analytical or clinical performance.

Instead, the document is a Special 510(k) Premarket Notification for a line extension to an existing acetabular system. The purpose of this type of submission is to demonstrate that a modified device is substantially equivalent to a legally marketed predicate device, not to establish performance against specific acceptance criteria for a new device.

The "Testing Summary" section mentions:

• Engineering analysis was used to ensure the risk of cam-out for the subject device is less than the risk associated with predicate devices.
• Hip wear simulator testing of a similar cup liner was used to demonstrate comparable safety and effectiveness of the new liner sizes to the predicate devices.

However, it does not provide:

• Specific acceptance criteria (e.g., maximum allowable wear rate, specific cam-out force thresholds).
• Detailed results from these tests or how they "prove" meeting acceptance criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone studies, or details about training sets/ground truth for machine learning algorithms. This is because the device (acetabular liners for hip replacement) is a physical medical implant, not an AI/ML-driven diagnostic or analytical device.

Therefore, I cannot provide the requested table and information, as the input document describes a mechanical device submission, not an AI/ML device submission that would typically involve such performance metrics and study designs.

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