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The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis 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 intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trabecular Metal Acctabular Revision Shell (K050937, cleared May 11, 2005), forms the acetabular component of a total bip prosthesis. The device consists of a Longewire highly crosslinked polyethylene liner and a Tivanium " Titanium alloy constraming ring. The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs. Subject acetabular liners are available in mner diameters of 28. 32 and 36mm.

The provided text describes a medical device submission (K072121) for the Trabecular Metal™ Acetabular Revision System Cemented Constrained Liner.

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than setting new, specific performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" are implied by the demonstration of substantial equivalence.

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

• The document explicitly states: "Clinical data and conclusions were not needed for this device."
• Therefore, there was no test set of clinical data (images, patient outcomes, etc.) used. The evaluation was based on non-clinical (mechanical) testing.
• Data Provenance: Not applicable, as no clinical data was used.

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

• Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication was used.

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

• No MRMC study was done, as this is a physical medical device (an acetabular liner) and not an AI-based diagnostic or assistive technology.

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

• Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical mechanical testing, the "ground truth" would be established by engineering standards and specifications for mechanical properties (e.g., strength, wear resistance, range of motion). The mechanical testing would assess if the device meets these pre-defined engineering performance targets and compares favorably to the established performance of the predicate device under similar testing conditions.

8. The Sample Size for the Training Set

• Not applicable, as no AI/machine learning model was being trained. The "training set" concept does not apply to the mechanical testing of this physical device.

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

• Not applicable, as there was no training set for an AI/machine learning model. For mechanical testing, the equivalent would be the established engineering specifications and the performance characteristics of the predicate devices.

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