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The TranSet™ System are fixation devices indicated in bone, tissue, ligament, and tendon repair. The system allows for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, and tendon repair. The compression and holding together of bone, tissue, ligament, and tendon fragments of the system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site:

• Up to USP Size No. 2 Suture,
• Up to USP Size No. 2 High Tensile Suture,
• Metallic Cable, and
• Metallic Wire.

The TranSet™ System intended use is in the dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system consists of a cannulated drill, a lead button or anchor, a flexible material that runs across a repair site, a metallic crimp, and a manual hand held crimping instrument. The flexible material is tensioned and secured with a metallic crimp by the manual hand held instrument allowing a compressive load to be applied across the repair site. This compression and holding together of the bone, tissue, ligament, and tendon fragments further promotes healing at the repair site. Lead buttons or anchors with a corresponding flexible material are provided sterile for single patient use. Cannulated drills for delivery of the implant materials are single patient use. The reusable crimping instrument and a sterilization tray for autoclaving complete the system.

The provided document describes a Special 510(k) submission for a modification to the TranSet™ System, a fixation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through design verification testing.

Therefore, the study described is a predicate comparison study focusing on mechanical strength and failure modes, rather than an AI or clinical performance study. Many of the requested details about acceptance criteria for AI devices, and the characteristics of a clinical study, are not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Implied" Criteria: The document directly states that "Design verification testing identified and conducted as part of the predicate comparison compared the mechanical strengths and failure modes of the modified TranSet™ System to predicate devices." The positive outcome ("Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices") implies these were the critical acceptance criteria for this specific 510(k) submission.

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

• Sample Size: The document does not specify the sample size for the design verification testing. It only states that "Design verification testing identified and conducted as part of the predicate comparison compared the mechanical strengths and failure modes..."
• Data Provenance: This was retrospective data in the sense that the testing was performed on the modified device and compared against existing predicate devices. The country of origin for the data is not explicitly stated, but given the company (Bonutti Research, Inc.) is based in Illinois, USA, it's reasonable to assume the testing and data generation occurred in the USA.

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

• Not Applicable. This was a mechanical engineering design verification study, not a clinical study requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" would be objective measurements of mechanical properties.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this was a mechanical engineering study. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical data, which is not relevant here.

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

• No. The document does not mention any MRMC study. This is a 510(k) for a mechanical fixation device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is not an AI algorithm. The device itself (TranSet™ System) is the "standalone" component being evaluated for its mechanical properties.

7. Type of Ground Truth Used

• The ground truth in this context was objective mechanical measurements (e.g., tensile strength, displacement at failure, etc.) obtained through design verification testing. These are empirical measurements, not expert consensus, pathology, or outcomes data in the medical sense.

8. Sample Size for the Training Set

• Not Applicable. This product is a mechanical medical device, not an AI model that requires a "training set."

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

• Not Applicable. As this is not an AI model, there is no training set or ground truth in that context.

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