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The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• e Rheumatoid arthritis:
• . Correction of functional deformity;
• . Congenital dislocation:
• . Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur. .

The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

The provided text describes a 510(k) premarket notification for the "Interface™ Acetabular Cup Liners." This submission focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study of the device's clinical performance against specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets (relevant to AI/ML device studies) is not applicable to this 510(k) submission for a physical orthopedic implant.

Here's why and what information is available:

• Nature of the Device: The Interface™ Acetabular Cup Liners are physical medical devices (orthopedic implants) used in total hip replacement procedures. They are not an AI/ML algorithm or software that performs diagnostic or prognostic functions.
• Regulatory Pathway (510(k)): A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (often mechanical testing for implants) to established, safe, and effective devices. It does not generally require new clinical trials or performance studies against predefined clinical acceptance criteria in the same way an AI/ML device would.

What is provided in the document and how it relates to "acceptance criteria" for a physical device:

The "acceptance criteria" in this context are primarily the demonstration of substantial equivalence to predicate devices. The study proving this involves detailed comparisons rather than a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly meeting the design, material, and functional equivalence to the predicates. The "reported device performance" is the comparison showing these equivalences.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a clinical study involving a test set of patient data. The "test" is the comparison of device characteristics to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. The "ground truth" is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. For this 510(k) submission, the "ground truth" (or basis of comparison) is the known safety and effectiveness profiles of the predicate devices (Interface™ (K031110), ApeX-LNK Poly™ (K062489 and K073150), and Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners) as determined by their prior FDA clearances and long-standing use in the market.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (acetabular cup liners). The "study" proving it meets "acceptance criteria" involves a detailed comparison of its design, materials, and intended use against already cleared predicate devices. The concepts of test sets, training sets, expert ground truth, and AI-assisted performance are not relevant to this type of regulatory submission.

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