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The OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• 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 OMNI Interface Acetabular System is intended for cementless and single use implantation only.

The OMNI Interface Acetabular System consists of acetabular cups/shells that are made of titanium alloy, standard and crosslinked ultra high molecular weight polyethylene shell inserts and femoral heads that are used with compatible femoral hip stems for primary and revision total hip replacement. The shells are available in “no hole” and “3-hole” configuration and a size range from 46-76 mm and X size (48x-58xmm).

The provided document is a 510(k) summary for the OMNI Interface™ Acetabular System, which is a medical device (hip implant). It is not an AI/ML device, and therefore the concepts of acceptance criteria for an algorithm, study design for AI models, ground truth, expert adjudication, or MRMC studies are not applicable.

The document discusses the substantial equivalence of the OMNI Interface™ Acetabular System to predicate devices. Substantial equivalence in this context means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's an interpretation of the relevant information provided, framed as closely as possible to your request, but adapted for a non-AI medical device:

The "acceptance criteria" for a medical device like the OMNI Interface™ Acetabular System are typically related to its physical and mechanical performance, biocompatibility, and intended use as compared to existing, cleared devices. The "study that proves the device meets the acceptance criteria" refers to the testing and comparison performed to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI device, there are no "performance metrics" in the sense of sensitivity, specificity, etc. The acceptance criteria relate to the device's characteristics and its ability to function as intended without raising new safety or effectiveness concerns compared to a predicate device.

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

This information isn't directly applicable as it's not an AI model. For mechanical medical devices, testing typically involves simulating physiological conditions using specific numbers of samples (e.g., a certain number of implants tested for fatigue or range of motion).

• Test Set (for mechanical testing): The document mentions "The results of testing for the proposed use of OMNI Interface Acetabular System with the Paragon Stem met the performance requirements for range of motion per ISO 21535." It also states "compatibility and mechanical testing." The specific sample sizes for these mechanical tests are not provided in this summary but would have been part of the full 510(k) submission.
• Data Provenance: Not applicable in the AI sense. The "data" here would be the results of laboratory mechanical and material tests conducted on the physical devices.

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

This concept is not applicable to this type of medical device submission. "Ground truth" in the context of AI refers to expert-labeled data for training and evaluating an algorithm. For a hip implant, the "truth" is established by manufacturing standards, preclinical mechanical testing, material specifications, and comparison to the performance of existing legally marketed predicate devices. No human experts are "labeling" data for an outcome here in the AI sense.

4. Adjudication Method:

Not applicable. Adjudication methods (like 2+1, 3+1) are used in AI studies to resolve disagreements among human labelers establishing ground truth. For a hip implant, material properties and mechanical performance tests have objective outcomes measured by equipment.

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

Not applicable. MRMC studies are used to evaluate how an AI algorithm affects the performance of human readers (e.g., radiologists interpreting images). This device is a physical implant, not an interpretive algorithm.

6. Standalone Performance:

Not applicable. "Standalone performance" refers to the algorithm's performance without human intervention. This device is a component of a total hip replacement, which is entirely reliant on human surgeons for implantation and human patients for its function. The closest equivalent would be the mechanical performance of the device components themselves, which is implicitly what the "testing" section refers to.

7. Type of Ground Truth Used:

Not applicable in the AI sense. For this device, "truth" is established by:

• Engineering design specifications.
• Conformity to international standards (e.g., ISO 21535 mentioned for range of motion).
• Material science properties.
• Biocompatibility assessments.
• Demonstration of substantial equivalence to predicate devices which have a known history of safe and effective use.

8. Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set exists for this device.

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