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The TOEGRIP® is intended for toes for general use in skeletally mature individuals undergoing surgery limited to interdigital fusion.

The TOEGRIP® device is intended to be permanently implanted without any other additional device as an intramedullary bone fastener device for toes or fingers.

The TOEGRIP® device is indicated for small bone reconstruction limited to interdigital fusion of toes in the following cases, listed in random order:

• . Rigid PIP joints deformities
• . Rigid hammertoes deformities
• . Claw toes deformities (PIP and DIP joints)
• Revision hammertoes surgeries .
• . Shortening osteotomies of the proximal phalanx

The TOEGRIP® device consists of a monobloc implant with three flexible prongs inserted intramedullary into each part of phalanx The prongs are linked by a T-shaped beam. The fixation concept is based on a press-fit contact due to its tapered shape and the sharp macrostructures once impacted.
The TOEGRIP® device is intended for single use only, and is available in a range of 5 sizes with 3 possible degrees: 0°, 10° or 20°.
The TOEGRIP® device is manufactured with material according to the ISO-10993, ZENIVA® PEEK.
The feature design of the TOEGRIP® is substantially equivalent to the design features of other devices previously cleared for market.

The Synchro-Medical Toe Grip Device underwent nonclinical testing to demonstrate its substantial equivalence to predicate devices.

1. Acceptance Criteria and Device Performance:

The document states that the Synchro-Medical Toe Grip Device met the acceptance criteria for the tests performed. However, the specific quantitative acceptance criteria or the reported device performance metrics are not detailed in the provided text.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document does not explicitly state the sample size used for the nonclinical tests (Static Four-point Bending Test and Dynamic Four-point Bending Test).
• Data Provenance: The tests were nonclinical (bench testing) and therefore do not have data provenance related to country of origin or retrospective/prospective human data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The study involved nonclinical mechanical testing, not human expert assessment for ground truth.

4. Adjudication Method for Test Set:

Not applicable. The study involved nonclinical mechanical testing, not human expert assessment requiring adjudication.

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

No. The document explicitly states, "No clinical tests were performed." Therefore, an MRMC comparative effectiveness study was not conducted.

6. Standalone Performance Study:

Yes, a standalone study (nonclinical mechanical tests) was performed for the algorithm/device. The device's performance was evaluated through:

• Static Four-point Bending Test
• Dynamic Four-point Bending Test

7. Type of Ground Truth Used:

The "ground truth" for these nonclinical tests would be the established engineering standards and specifications for bone fixation devices, against which the device's mechanical properties (e.g., bending strength, fatigue resistance) were measured.

8. Sample Size for Training Set:

Not applicable. This device is a physical implant, not a software algorithm that requires a training set in the context of machine learning.

9. How Ground Truth for Training Set was Established:

Not applicable. This device is a physical implant, not a software algorithm that requires ground truth for a training set.

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