Search Results

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.

Ask a specific question about this device