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RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.

RCI Fixation Screws are rounded head interference screws, which include diameters from 6 to 12 mm and a range of lengths from 25 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI Fixation Screw.

The provided text describes a 510(k) summary for RCI Fixation Screws, which is an orthopedic device. This type of device approval typically relies on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical studies involving human subject performance. Therefore, many of the requested details, such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set information, are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable for this type of submission. The performance was established through "bench testing," which refers to laboratory experimentation on the device itself, not human subjects or a dataset derived from them.
• Data Provenance: The data provenance is laboratory bench testing, not clinical data from countries of origin.

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

• Not applicable. The "ground truth" for mechanical properties like fixation strength is determined by engineering specifications and testing protocols, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are used in clinical trials or studies where there is subjective assessment of outcomes or images, which is not the case for bench testing of mechanical properties.

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

• Not applicable. This is a medical device (fixation screw), not an AI-powered diagnostic or decision support system. Therefore, MRMC studies comparing human reader performance with or without AI assistance are irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance evaluation was based on engineering standards and measurements of fixation strength obtained through bench testing.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

• Not applicable. See point 8.

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