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The indications for the Regenerex™ Tibial Components include:

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  These devices are single-use implants intended for cemented or uncemented applications.

The Regenerex™ Tibial Components are intended for primary knee arthroplasty and utilize the existing Biomet tibial tray profile and sizing system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Regenerex™ Tibial Components:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission is a 510(k) for substantial equivalence, not a de novo submission presenting novel acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed against the established safety and effectiveness of the predicates.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The submission relies on non-clinical (laboratory) testing for "substantial equivalence" rather than a clinical "test set" from patients.
• Data Provenance: Not applicable, as no human clinical data (prospective or retrospective) from specific countries are mentioned for evaluation of the device's performance.

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

Not applicable. No clinical test set with ground truth established by experts is described. The evaluation was primarily non-clinical.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted, and no effect size for human readers with/without AI assistance can be determined.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The device described (Regenerex™ Tibial Components) is a medical implant, not an AI algorithm. There's no mention of an algorithm or standalone performance testing for AI. The "non-clinical testing" mentioned refers to laboratory tests on the physical implant.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic or AI systems is not directly relevant here. For a physical implant, "ground truth" would be inherent in the physical and mechanical properties demonstrated through laboratory testing (e.g., material strength, wear resistance, dimensional accuracy) against established industry standards or predicate device specifications. The document implies performance was compared against the "intended use" and "predicate devices."

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no "training set."

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