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The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

The proposed device is an all-inside meniscal repair system. The implant consists of two rigid backstops (absorbable PLGA1 or non-absorbable PEEK2), size #2-0 Orthocord suture and UHMWPE braid. The implant system and applier are pre-assembled, and the whole device is sterile, for single patient use only. Compression of the fixation point is accomplished by pulling on the suture post to allow the two suture strands creating the bridge between the implants to lay tight on the surface of the fixation point. *1 PLGA: Poly(lactide-co-glycolide) *2 PEEK: polyaryletherketone

The provided text is a 510(k) summary for the TRUESPAN™ Meniscal Repair System. It describes a medical device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about an AI-powered device or a study proving an AI device meets acceptance criteria.

Specifically, the document discusses:

• Device Name: TRUESPAN™ Meniscal Repair System
• Intended Use: Meniscal repair and meniscal allograft transplant procedures, anchoring the allograft to the meniscal rim.
• Device Description: An all-inside meniscal repair system consisting of rigid backstops (absorbable PLGA or non-absorbable PEEK), #2-0 Orthocord suture, and UHMWPE braid. The system is pre-assembled, sterile, and for single patient use.
• Safety and Performance: States that "Implant system strength was evaluated in vitro and after cyclic (bench top). The testing demonstrated substantial equivalence of performance to the predicate device. Biocompatibility is also confirmed based on biocompatibility data and justification. The proposed device has raised no new issue of safety and efficacy."
• Substantial Equivalence: Concludes that the proposed device is substantially equivalent to the predicate device based on similar technological characteristics and comparable implant system strength.

Since the request asks for details about an AI-powered device and a study proving its acceptance criteria, and the provided text describes a meniscal repair system (a physical medical implant) and its mechanical/biocompatibility testing, I cannot fulfill the request using only the provided text. The information requested (acceptance criteria table, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) is typical for AI/software as a medical device (SaMD) clearances, not for a physical implant like the TRUESPAN system.

Therefore, I cannot provide the requested table or answer the specific questions about AI device performance and studies based on the given document.

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The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.

The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.

The provided text describes a medical device, the A.I.M. Knotless Meniscal Repair Device, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with diagnostic AI/imaging devices.

The document states: "Bench testing was conducted to confirm that the A.I.M. Knotless Meniscal Repair Device performs as well or better than the predicate on pull-out performance and cyclic loading." This indicates performance testing was done, but the specific acceptance criteria (e.g., minimum pull-out strength in Newtons, number of cycles survived at a certain load) and the detailed results are not provided in the given text.

Therefore, I cannot fill out the requested table or answer most of the questions as the necessary data is absent from the provided text.

Here's what I can infer from the text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

All other requested information regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, training set details, and ground truth establishment methods is not available in the provided document, as it focuses on a a physical medical device (suture retention device) and its substantial equivalence and not an AI or imaging diagnostic device. The 'study' mentioned is a bench test to compare mechanical properties with a predicate, not a clinical or AI performance study.

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The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.

The proposed OMNISPAN Meniscal Repair System consists of two sterile PEEK (polyetheretherketone) implants connected by a sliding loop and fixed leg of absorbable size #2-0 Orthocord suture, a sterile, disposable Deployment Gun with malleable Graft Retractor. The implants together with the suture provide compression across the tear in the meniscus.

This submission describes the OMNISPAN Meniscal Repair System, a medical device for arthroscopic fixation of meniscal tears. The submission asserts substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K092836) is a 510(k) summary for a medical device seeking substantial equivalence, rather than a clinical study reporting specific performance metrics against pre-defined acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, as would be found in a clinical trial report, is not present in this document.

Instead, the document states: "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." This general statement indicates that internal testing was conducted to support the device's suitability, but the specific acceptance criteria and detailed performance results are not disclosed in this summary. The FDA's decision to clear the device implies that the agency found these undisclosed tests satisfactory.

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

This document does not describe a clinical test set with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, supported by internal performance and safety testing, the details of which are not provided in this summary.

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

Given that no clinical test set is described in detail, there is no information provided regarding experts used to establish ground truth.

4. Adjudication Method for the Test Set

As no clinical test set is described, there is no information on any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on device characteristics and predicate devices, not on direct comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical medical implant (OMNISPAN Meniscal Repair System), not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not reported.

7. Type of Ground Truth Used

The document does not describe a specific "ground truth" as would be used in an AI or diagnostic device study. The "ground truth" here pertains to the device's functionality and safety, which would have been established through internal engineering tests, biocompatibility assessments, and mechanical testing, rather than expert consensus on diagnostic images or pathology.

8. Sample Size for the Training Set

This device is a physical medical system; it does not involve an AI algorithm with a training set. Therefore, this question is not applicable.

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

As this device does not involve an AI algorithm, the concept of a "training set" and its associated ground truth is not applicable.

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