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The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acefabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liner and Shell Construct is a multi-piece acetabular component made up of an R3 Shell and the Constrained Liner Constrained Liner Construct includes a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer poly support ring.

The R3 Constrained Liner may be used with previously implanted femoral stems, femoral heads and acetabular shells as in a revision case, or it may be used in primary cases and implanted along with a shell, head and stem. The R3 Constrained liner was designed to be used with existing Smith & Nephew hip components. The R3 Constrained Liner should not be used with ceramic femoral heads or skirted femoral heads of any material.

The provided document is a 510(k) summary for the Smith & Nephew R3 Constrained Liners. This document details the regulatory clearance process for a medical device and relies on showing "substantial equivalence" to a predicate device, rather than explicit acceptance criteria and performance studies for the new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document states:

• D. Summary of Technological comparison: "The intended use, design, and materials of the R3 Constrained Liners are substantially equivalent to the previously cleared Osteonics Constrained Liners (P960047). Design Control Activities have been completed and the results indicated that the subject device is safe and effective."

This indicates that the safety and effectiveness of the R3 Constrained Liners were established through design control activities and a comparison to a predicate device, rather than through a performance study against predefined acceptance criteria for the new device as would be typical for software or AI medical devices.

To answer your request, if this were a software/AI device, I would need a different type of submission document that would detail performance studies.

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Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners are components of the Exactech AcuMatch A-Series® or MCS® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.

Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell.

The provided document is a 510(k) summary for the Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own meeting specific acceptance criteria and reporting on device performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The submission relies on performance testing according to an FDA guidance document and consensus standards, and a comparison to known predicate devices regarding materials, dimensions, and performance characteristics.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "Performance Testing" and "evaluation included a Risk Analysis and Comparison to Standards." This typically involves bench testing of a representative sample of devices, but the exact number of units tested is not provided.
• Data Provenance: Not specified, but generally, such performance testing is conducted in a laboratory setting by the manufacturer or a contracted testing facility. It is not clinical data (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is a device performance test, not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for material and mechanical properties would be established by validated testing methods and adherence to specified ASTM standards.

4. Adjudication Method for the Test Set:

• Not applicable. This is not a study involving expert adjudication. Performance testing against standards does not typically involve an adjudication method in the human-in-the-loop sense.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a mechanical medical device like an acetabular liner.

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

• Yes, in a sense, a "standalone" performance evaluation was done. The device itself was evaluated against established engineering standards and guidance documents. This is a standalone evaluation of the physical device's mechanical properties and material compliance, without human interpretation in a clinical context.

7. The Type of Ground Truth Used:

• Bench Test Results / Engineering Standards: The "ground truth" for this device's performance evaluation is adherence to the specifications outlined in ASTM F648 (for UHMWPE) and ASTM F136 (for Ti-6A1-4V), as well as compliance with the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." This involves objective measurements of material properties, mechanical strength, and other design characteristics.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

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