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The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

The RIGIDLOOP Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached non-absorbable fiber loop. This implantable fiber loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The device is offered in size ranges of 15-60mm in 5mm increments. Reamers and depth gauges are provided separately as reusable accessories to assist in the placement of the RIGIDLOOP Cortical Fixation System.

The provided text describes the RIGIDLOOP Cortical Fixation System, a medical device for soft tissue to bone fixation, particularly for ACL repair. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through detailed clinical studies with acceptance criteria, sample sizes, and ground truth establishment in the way an AI/ML device would be evaluated.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in the provided document. However, I can extract information related to the device's performance assessment and substantial equivalence claims.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance
   • The document does not provide explicit, quantitative acceptance criteria in the format typically seen for AI/ML device performance (e.g., minimum sensitivity, specificity, or AUC).
   • Instead, the assessment is based on demonstrating "substantial equivalence" to predicate devices through comparisons of materials, design, and principal operation, supported by non-clinical testing.
   • Reported Device Performance: The document states, "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." This is a qualitative statement of suitability rather than specific performance metrics against acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This information is not provided in the document. The document describes "verification activities" and "testing assessments" but does not detail the sample sizes for these tests, nor their provenance, as these are non-clinical (mechanical, sterilization, biocompatibility) rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This information is not applicable/not provided for this type of device submission. The device is a mechanical implant, not an AI/ML diagnostic tool requiring expert-established ground truth from medical images or clinical data. "Ground truth" in this context would likely refer to engineering specifications and test results, not expert medical consensus on diagnostic interpretations.

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

   • This information is not applicable/not provided. Adjudication methods are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in ground truth, which is not relevant for this device.

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/not provided. The RIGIDLOOP Cortical Fixation System is a physical implant; it is not an AI algorithm that assists human readers/clinicians, so no MRMC study or AI assistance effect size is relevant to this submission.

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

   • This information is not applicable/not provided. This device is a mechanical implant, not an algorithm.

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

   • For this device, "ground truth" would relate to the performance of the implant itself, evaluated through non-clinical testing. The document states "Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility."
   • Therefore, the "ground truth" would be established by engineering tests and standards (e.g., measuring pull-out strength against a specification, verifying sterility, confirming biocompatibility per standards).

8. The sample size for the training set

   • This information is not applicable/not provided. There is no "training set" in the context of this device because it is not an AI/ML algorithm.

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

   • This information is not applicable/not provided. As above, there is no training set for this device.

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