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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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The ProCinch, QuadCinch Adjustable Loop Device is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

The Riverpoint Medical ProCinch, QuadCinch adjustable button loop is comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE, or polyester are looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white) or with trace filaments of blue or green color suture.

For configurations that do not have a titanium plate preattached, a titanium plate component is affixed to the loop during the procedure. For models that come with a preattached titanium plate, the procedure is the same except the titanium plate is passed through the channel. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the femoral channel and secure into place. The UHMWPE is available undyed (white), dyed blue, or with trace filaments of blue or green color suture. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

This FDA 510(k) K240194 submission for the Riverpoint Medical ProCinch, QuadCinch device does not describe an AI/ML powered device or a study involving human readers with or without AI assistance. Therefore, many of the requested criteria related to AI/ML performance and human reader studies are not applicable or cannot be extracted from the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a comparison of technical characteristics for a medical device (adjustable button loop for tissue fixation), not an AI/ML algorithm.

Here's the information that can be extracted based on the provided text, with clarifications where the criteria are not applicable:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

As this submission is for a medical device (ProCinch, QuadCinch Adjustable Button Loop) and not an AI/ML powered diagnostic or assistive device, the "acceptance criteria" and "study" described are primarily focused on demonstrating the device's safety and effectiveness through comparison with a predicate device and adherence to relevant standards for medical devices. The performance data focuses on mechanical testing, sterilization, biocompatibility, and packaging validation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to established standards and comparable performance to the predicate device. The performance reported is that the device met all requirements and performed comparably.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "cadaveric models" for usability testing and "non-clinical mechanical testing" and "LAL and rabbit pyrogenicity testing." However, specific sample sizes for these tests are not provided in the given text. The provenance includes:

• Cadaveric models: (location not specified, likely lab-based)
• Animal testing: Rabbit pyrogenicity testing (location not specified, likely lab-based)
• Mechanical testing: In-vitro lab testing (location not specified, likely lab-based)

The data is non-clinical and largely prospective in the context of the device's development and testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This criterion is not applicable as this is not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this device's performance is established through physical and chemical testing against recognized standards (e.g., ISO, USP) and comparison to a predicate device.

4. Adjudication Method for the Test Set

This criterion is not applicable as this is not an AI/ML device requiring human expert adjudication of results. Testing is based on objective measurements against established standards.

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 criterion is not applicable. No AI assistance is mentioned or involved with this device.

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

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

7. The Type of Ground Truth Used

The ground truth for this medical device's performance is established through:

• Adherence to recognized standards: e.g., USP for sutures, ISO 10993 for biocompatibility, ISO 11607 for packaging, EN62366 for usability.
• Empirical mechanical testing: Comparing fixation strength against a predicate device.
• Biological testing: LAL and rabbit pyrogenicity testing.

8. The Sample Size for the Training Set

This criterion is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This criterion is not applicable as this is a physical medical device, not an AI/ML algorithm.

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