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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 OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair

The Riverpoint Medical Interfacing Anchor is comprised of a pre-deployed all-suture anchor with attached repair sutures and 302 stainless steel needles. The Interfacing Anchor is inserted into either the humerus or into passing slots available in devices intended for total shoulder arthroplasty. The Riverpoint Medical Bone Tunnel Construct is comprised of a double armed Ultra-High Molecular Weight Polyethylene (UHMWPE) suture with a preassembled polypropylene passing loop and 302 stainless steel needles. Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA authorized. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Interfacing Anchor and Bone Tunnel Construct are available in common sizes and lengths with preattached 302 stainless steel needles and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text is a 510(k) summary for the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct. This document details the regulatory review process for a medical device and its substantial equivalence to a predicate device.

It does NOT describe an AI/ML-driven medical device, nor does it contain information about diagnostic performance metrics (e.g., sensitivity, specificity, AUC), test set characteristics, expert adjudication processes, or MRMC studies.

The "Performance Data" section of the document refers to non-clinical performance testing for a surgical device (an anchor and tunnel construct), not a diagnostic AI. The tests mentioned are:

• Usability engineering validation with simulated use in cadaveric models (EN62366:2015)
• Endotoxin/pyrogenicity testing (ANSI/AAMI ST72:2019, USP <161>, USP <151>, USP <85>)
• Mechanical testing to verify fixation strength (cyclic and pullout testing)

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided text pertains to a physical surgical device.

To directly answer your prompt based on the provided text, the following cannot be extracted:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy (as it's not a diagnostic device). The acceptance criteria mentioned are for mechanical and usability performance of a surgical implant.
• Sample sizes used for a "test set" in the context of image analysis or diagnostic performance. The "test set" here refers to cadaveric models and mechanical testing samples.
• Data provenance (country of origin, retrospective/prospective) for a diagnostic dataset.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for the training set was established.

However, based on the provided text, here's what can be inferred or directly stated about the "acceptance criteria" and "study" for this specific device (a surgical implant):

Acceptance Criteria and Device Performance (for a surgical implant):

Study Details (for this surgical implant):

1. Sample sizes used for the test set and data provenance:

   • The "test set" refers to samples for mechanical testing and cadaveric models for usability. Specific numerical sample sizes are not provided in this summary.
   • Data provenance is not described (e.g., where the cadavers came from, or if the mechanical tests were done by a specific lab).
   • The studies were non-clinical ("bench testing" and "simulated use").

2. 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):

   • Not applicable in the context of diagnostic "ground truth." The "ground truth" for a surgical implant's mechanical performance is defined by engineering standards and comparative testing to predicates. Usability testing would involve typical users (surgeons, OR staff), but the number or qualifications are not specified.

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

   • Not applicable as this is not a diagnostic study requiring human expert consensus/adjudication of results. Performance is measured against physical test standards and engineering specifications.

4. 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:

   • No, a MRMC comparative effectiveness study was not done. This is a physical surgical device, not an AI/ML diagnostic tool.

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

   • Not applicable as this is a physical surgical device, not an algorithm.

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

   • For mechanical testing: Engineering specifications and comparative performance to a legally marketed predicate device.
   • For usability testing: Performance in simulated use conditions in cadaveric models against predefined usability objectives (derived from EN62366:2015).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device with a "training set."

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

   • Not applicable.

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JuggerKnot® Soft Anchors are intended for soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment

The JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three nonabsorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type). Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. JuggerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text is a 510(k) summary for a medical device (JuggerKnot® Soft Anchor) that has received FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic test.

Therefore, the information required to populate the fields related to AI/ML device performance (like "acceptance criteria table," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set") is not present in the provided document.

The document describes non-clinical mechanical testing and usability engineering validation, but these are not the types of studies that would generate the performance metrics typically requested for an AI/ML or diagnostic device's acceptance criteria table.

Here's a breakdown of what is available and what is not:

Information Present in the Document (relevant to general device clearance, but not AI/ML specific):

• Device Name: JuggerKnot® Soft Anchor
• Intended Use/Indications for Use: Detailed list of soft tissue to bone fixation indications (e.g., Knee MPFL, Shoulder Rotator Cuff).
• Predicate Device: K203740 – Riverpoint JuggerKnot® Soft Anchor.
• Performance Data (General):
  • Sutures meet USP requirements (except diameter).
  • UMHWPE sutures tested for needle attachment and tensile strength per USP.
  • Followed FDA Guidance documents for "Bone Anchors" and "Surgical Sutures."
  • Biocompatibility, sterilization method, packaging, material stability are the same as the predicate.
  • Non-clinical performance testing:
    • Usability engineering validation with simulated use in cadaveric models per EN62366:2015.
    • Endotoxin/pyrogenicity testing per ANSI/AAMI ST72:2019, USP <161>, USP <151>, USP <85>.
    • Mechanical testing (insertion, cyclic, and pullout testing) comparing to predicate and other marketed soft anchor devices.
• Conclusion: Device performed comparably to the predicate and met all requirements for its intended use, demonstrating substantial equivalence.

Information NOT Present in the Document (required for the requested AI/ML acceptance criteria study description):

1. A table of acceptance criteria and the reported device performance: This document does not present performance in terms of sensitivity, specificity, accuracy, or similar metrics typically seen for AI/ML or diagnostic devices. Instead, it discusses mechanical performance relative to a predicate.
2. Sample sized used for the test set and the data provenance: No "test set" in the context of an AI/ML algorithm is mentioned. The mechanical testing implicitly used a "test set" of anchors, but the size and provenance are not detailed, nor is it the type of test set requested (e.g., patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic ground truth being established.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone performance: While the device has "standalone performance" as a mechanical anchor, this isn't relevant to "algorithm only without human-in-the-loop performance."
7. The type of ground truth used: Not applicable in the AI/ML context. Ground truth for a mechanical device is its physical performance characteristics.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the clearance of a mechanical medical device (a surgical anchor) based on its substantial equivalence to an existing predicate. It does not pertain to an AI/ML algorithm or a diagnostic device, and therefore, the requested information regarding AI/ML acceptance criteria and study details cannot be extracted from this text.

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