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AcuMatch® A-Series Enhanced Polyethylene Acetabular Liners are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

This Special 510(k) premarket notification describes a material change from the predicate AcuMatch® A-Series UHMWPE polyethylene acetabular liners to acetabular liners manufactured from Enhanced Polyethylene. Additionally 5 new sizes are being introduced to the A-Series system.

The provided document, K051556, pertains to a medical device submission for the Exactech® AcuMatch® A-Series Enhanced Polyethylene Acetabular Liner. This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance studies for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/algorithm-driven medical device.

Specifically, the document describes:

• A material change for an existing acetabular liner and the introduction of new sizes.
• The device description, intended use, and contraindications.
• Legally marketed predicate devices to which the new device is compared for substantial equivalence.
• The FDA's decision regarding substantial equivalence.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details about retrospective/prospective studies.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

These types of details are typically found in submissions for novel AI/ML-driven medical devices or those requiring de novo classification or PMA applications, which involve rigorous clinical performance evaluations against predefined statistical endpoints. This document, being a 510(k) for a material and size change, relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, primarily through non-clinical (e.g., mechanical testing) comparisons, rather than human-reader performance studies.

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