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The Rayhack Low Profile Locking Plate is a metallic surgical implant intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.

The Rayhacks Low Profile Locking Plate and Instruments is an implant intended for fixation of long bones to assist healing. The implant is fabricated from stainless steel. It is fixated with two 2.7mm locking screws, four 3.5mm standard cortical screws and one 2.7 standard interfragmentary cortical screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.

The acceptance criteria and study details for the Rayhack Low Profile Locking Plate are as follows:

1. Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document states "Bone Model Testing," which implies a laboratory setting, likely using a limited number of bone models.
• Data Provenance: The testing was conducted as part of the 510(k) submission process, suggesting an internal study by the manufacturer. The data provenance is not further detailed (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the performance data is based on physical bone model testing, not interpretation by human experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the performance data is based on physical bone model testing, not interpretation by human experts.

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:

This information is not applicable. The device is a bone fixation plate, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

This information is not applicable. The device is a physical bone fixation plate, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the bone model testing would be the measured physical properties (holding strength and stiffness) of the bone models with and without the device, and the direct comparison of these measurements to establish substantial equivalence with the predicate device.

8. The sample size for the training set:

This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above.

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