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The RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.

The RootMend Meniscal Root Repair (MRR) devices are composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material. RootMend MRR devices are available with a fixation button composed of a titanium (Ti-6Al-4V) button, or with an attached UHMWPE fixation button. RootMend MRR devices will be provided sterile using ethylene oxide, for single use only, and are not to be resterilized. The UHMWPE is available undyed (white), black, or blue, with trace filaments of black or blue. RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.

The provided text from the FDA 510(k) summary for the RootMend MRR device states that "Non-clinical mechanical testing was performed to verify the fixation strength of the RootMend MRR devices and is compared to the predicate device. Testing conducted includes cyclic and ultimate tensile strength (UTS) testing, and assessment of displacement for the subject button and predicate anchor constructs. Usability engineering testing with simulated use in cadaver lab was performed on the subject device per EN62366-1. In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended."

However, the provided document does not contain the specific acceptance criteria or the detailed results (e.g., reported device performance values) from the mechanical testing and usability testing. It also lacks information regarding sample size, ground truth establishment, expert qualifications, or MRMC studies that would be relevant for an AI/software device evaluation.

Therefore, I cannot fulfill the request the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: Not provided.
• Sample sized used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device and testing described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is a hardware device, not an AI/software device assisting human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is the specified performance thresholds (acceptance criteria) and the measured physical properties. For usability testing, the 'ground truth' is successful completion of tasks by users in a cadaver lab. Specifics are not detailed beyond "performed as intended."
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Based on the available information, here is what can be inferred or directly stated:

1. Acceptance Criteria and Device Performance:

The document states: "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended."

• Acceptance Criteria: Not explicitly stated in quantitative terms. They likely relate to minimum cyclic and ultimate tensile strength, and maximum displacement relative to the predicate device.
• Reported Device Performance: Not explicitly stated in quantitative terms. The performance met the unstated acceptance criteria.

2. Sample Size and Data Provenance:

• Sample Size: Not specified for any of the tests (cyclic, UTS, displacement, usability).
• Data Provenance: The tests were "non-clinical mechanical testing" and "usability engineering testing with simulated use in cadaver lab." This implies laboratory/bench testing rather than human clinical data. The location of the testing or data origin (country) is not specified.

3. Experts for Ground Truth / Adjudication / MRMC studies / Standalone Performance:

• These concepts (experts, adjudication, MRMC, standalone performance) are typically relevant for AI/software-based medical devices that interpret medical images or data. The RootMend MRR is a physical orthopedic implant (metallic bone fixation fastener). Therefore, these criteria are not applicable to the device and studies described.

4. Type of Ground Truth:

• For mechanical testing: The ground truth is established by engineering specifications and comparative performance to a predicate device. This would involve objective measurements of strength, fatigue, and displacement against predefined thresholds.
• For usability testing: The ground truth is successful completion of surgical tasks and safe operation in a simulated environment (cadaver lab) as assessed by the test protocol and observations.

5. Training Set Information:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a "training set."
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided FDA 510(k) summary provides a high-level statement that the device met acceptance criteria through specified non-clinical mechanical and usability testing, but it does not disclose the quantitative details of those criteria, the measured performance, or the sample sizes used. The remaining questions are not relevant given the nature of the device as a physical implant rather than an AI/software product.

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