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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 (NIDJD) 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, arthritis 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 hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Abbreviated Premarket Notification are R3 XLPE Acetabular Liner line additions in an anteverted liner option. Anteverted liners modify the face opening of the acetabular liner component. The subject devices are intended to be used in conjunction with existing R3 Acetabular Shells, and they are intended to articulate against appropriately sized, existing Smith & Nephew femoral heads. They are manufactured from XLPE material and will initially be offered in inner diameters of 32 and 36mm and outer diameters of 48-72/74mm.

R3 XLPE Acetabular Liners have previously been cleared for market under premarket notifications K070756 and K092386 in liner options of 0°,0° lateralized +4mm, 20°, and 20° lateralized +4mm. The subject R3 XLPE Anteverted Liners are very similar to the R3 XLPE 20° lateralized +4mm Acetabular Liners cleared under K070756. The differences are described below.

• The face of the acetabular liner has been changed by 20° to re-orient the opening face of . the liner relative to a given shell orientation when necessary
• Four vents have been added to the locking detail of the subject R3 XLPE Anteverted . Liners.

This document describes the R3 XLPE Anteverted Liners, a medical device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The device's performance was evaluated through a series of tests conducted in accordance with the guidance titled "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. A review of these tests demonstrated that there were no new issues related to the safety or effectiveness of the R3 XLPE Anteverted Liners. This evaluation compared the new device's performance against established criteria and the performance of previously cleared predicate devices.

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

The document does not specify the exact sample sizes used for the performance tests (e.g., number of liners tested for fatigue, wear, etc.). The data provenance is laboratory testing in accordance with an FDA guidance document, rather than clinical data from human subjects. Therefore, details like country of origin or retrospective/prospective are not applicable in the context of this device's testing.

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

Not applicable. The ground truth for this device's performance was established through engineering and materials testing standards outlined in the "Guidance Document for Testing Acetabular Cup Prostheses," not through expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the evaluation was based on standardized physical and mechanical tests, there was no need for an adjudication method among human reviewers. The results would be objectively measured against predefined criteria in the guidance document.

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 device is an orthopedic implant, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study involving human readers and AI is irrelevant to its evaluation.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's performance was engineering and materials testing standards and criteria as detailed in the "Guidance Document for Testing Acetabular Cup Prostheses." This includes objective measurements of properties like range of motion, attachment loads, fatigue life, wear rates, degradation, and corrosion resistance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and evaluation as described here.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device evaluation.

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