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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hin; and correction of deformity.

The R3 Acetabular System is for single use only and is intended for cementless use.

The subject of this Special 510(k) is the R3® Anteverted Liners. The subject R3 Anteverted Liners are a line extension to the R3 XLPE Liners that were cleared under premarket notifications K113848 and K093363. The R3 Anteverted Liners have same overall design, indication for use and material as the predicate R3 XLPE liners.

The subject R3 Anteverted Liners feature a 20° anteverted, or "face changing", entry angle to the articulating surface (Inner diameter). Also, a variable angle chamfer/bevel was added on the rim of the liner. The R3 Anteverted Liners have +4mm lateralized inside Diameter, 20° andle, and identical locking mechanism as the predicate R3 XLPE Liners, cleared under K113848 and K093363.

The R3 Anteverted Liners are available with Inner diameter (ID) sizes 28, 32, 36, 40 and 44mm and the Outer Diameter (OD) sizes ranging from 44 to 76-80mm.The R3 Anteverted Liner is manufactured from 10MRAD Cross-linked Polyethylene (XLPE) confirming to ASTM F648, as the predicate R3 XLPE Liners cleared under a premarket notification K113848 and K093363. The R3 Anteverted Liners are provided sterile and is intended for single use only.

The provided text describes a 510(k) submission for a medical device, the R3 Anteverted Liners, demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details about acceptance criteria, study design for AI, and expert involvement are not applicable to this document. The document focuses on demonstrating that the new device, a modification of an existing hip implant component, is just as safe and effective as previously cleared predicate devices through mechanical testing and comparison of characteristics.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a physical medical device (hip implant liner) demonstrating substantial equivalence to predicate devices, the "acceptance criteria" are primarily related to safety and performance characteristics being equivalent or comparable, supported by mechanical bench testing. There isn't a table of discrete acceptance criteria with numerical targets and reported performance in the way one would see for an AI/software performance study.

The primary "acceptance criteria" is that the new R3 Anteverted Liners are substantially equivalent to the predicate R3 XLPE Liners and other referenced devices in terms of:

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated for each mechanical test. The tests were performed on the R3 Anteverted Liners.
• Data provenance: Not explicitly stated in terms of country of origin. The testing was "non-clinical bench (mechanical) testing" for a physical device manufactured by Smith & Nephew, Inc. It can be inferred to be prospective as it was performed to support the 510(k) submission for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this document. Ground truth as typically defined for AI/software (e.g., expert annotations on images) is not relevant to the mechanical testing of a physical hip implant liner. The "ground truth" for mechanical testing is established by engineering standards and validated testing procedures.

4. Adjudication method for the test set

This is not applicable to this document. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in image analysis or clinical assessments, which is not what this submission describes. The validity of the mechanical tests is based on adherence to recognized standards and engineering principles.

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

This is not applicable to this document. An MRMC study is for evaluating the performance of AI-assisted diagnostic tools. This document is for a physical orthopedic implant.

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

This is not applicable to this document. There is no AI algorithm involved in the R3 Anteverted Liners.

7. The type of ground truth used

The "ground truth" for the mechanical testing of the physical device is based on engineering standards and established testing methodologies to evaluate material properties and mechanical performance (e.g., strength, stability, wear characteristics) against predefined requirements derived from predicate device performance and regulatory standards.

8. The sample size for the training set

This is not applicable to this document. There is no AI algorithm with a training set.

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

This is not applicable to this document. There is no AI algorithm with a training set or ground truth establishment in this context.

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