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Indications for use of the UNISYN™ HIP SYSTEM

A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.

B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

C) Proximal femoral fractures.

D) Avascular necrosis of the femoral head.

E) Non-union of proximal femoral neck fractures.

F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.

This document is a 510(k) summary for a medical device (Hayes Medical, Inc. UniSyn Modular Hip System) seeking clearance from the FDA. It does not describe a traditional clinical study with acceptance criteria and device performance as one would find for a software or diagnostic device.

Instead, this 510(k) pertains to a physical orthopedic implant and is a "Special 510(k)" because the only change made to a previously cleared device (UniSyn Hip System, K003649) is the addition of a hydroxylapatite coating to the existing TPS coating on the surface of the bodies.

Therefore, the typical metrics, sample sizes, expert ground truth, and study types requested in your prompt (e.g., MRMC, standalone algorithm performance) are not applicable to this type of regulatory submission for a physical implant. The "acceptance criteria" here are met by demonstrating "substantial equivalence" to predicate devices, primarily through material and design information, rather than a performance study as you've outlined.

However, I can extract information related to the substantial equivalence argument, which is the closest analogy to "acceptance criteria" in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for the "Reported Device Performance": In a 510(k) for an implant device, particularly a Special 510(k) that involves a minor modification to a previously cleared device, the "performance" is demonstrated by showing that the modified device remains as safe and effective as the predicate device(s). This is achieved by comparing various attributes (intended use, materials, design, technological characteristics) to predicates and arguing that any differences do not raise new questions of safety or effectiveness. The text explicitly states: "The safety and effectiveness of the Body, HA Plasma, Modular Hip are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission."

The remaining points of your request are not applicable to this 510(k) submission type, as it relates to a physical orthopedic implant device, not an AI/software device or a diagnostic requiring performance metrics like sensitivity/specificity derived from expert reviews.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. This pertains to a physical implant, not a software or diagnostic device. Substantial equivalence for this type of device is typically demonstrated through engineering assessments, material characterization, and comparison to predicate devices, not through a "test set" of patient data in the context of performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. This submission does not involve a "ground truth" derived from expert consensus on patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. There is no "test set" in the context of expert adjudication for this physical implant.

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 a physical implant, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. "Ground truth" in the context of expert review or pathology is not relevant for this implant's regulatory clearance. The "truth" here is established via engineering principles, material science, and the regulatory history of predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. As above, there is no "training set" or need for "ground truth" establishment in this context.

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