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The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.

The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.

I am sorry but this document does not contain the information requested. This document is a 510(k) summary for a medical device which describes the device, its indications for use, and its substantial equivalence to predicate devices based on non-clinical testing. It does not include information about acceptance criteria or specific studies that demonstrate the device meets those criteria in the way you have asked for (e.g., with detailed statistics on performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance).

Specifically, the document states:

• "No clinical testing was submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence for the Anika Tissue Tack Fixation System."
• The performance testing summarized includes "Mechanical retention strength, tensile & shear", "Degradation testing", "Insertion and removal evaluation", "Biocompatibility Testing", and "Bacterial endotoxin limit test". However, no specific acceptance criteria or detailed results are provided.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies for this device.

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The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.

The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a barbed suture manufactured from #1 USP nylon monofilament. The polyester sheath is coated with beeswax.

The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex SoftStitch device. It pertains to a surgical suture and implantable retention device, not an AI-powered diagnostic tool. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance metrics, ground truth, expert adjudication, or MRMC studies is not applicable and cannot be extracted from this document.

The document details the substantial equivalence of the modified Arthrex SoftStitch to a previously cleared predicate device (K190707) and a reference device (K203117). The performance data cited focuses on mechanical strength (tensile testing) and biocompatibility (bacterial endotoxin testing), which are standard for medical devices like sutures, but not relevant to AI/ML device performance.

Therefore, I cannot fulfill the request as the provided text does not contain information about the development and validation of an AI-powered medical device.

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The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.

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The provided text is a 510(k) Summary for a medical device called "FiberStitch™ Implant". This document details the device's classification, indications for use, and a comparison to predicate devices, including nonclinical testing performed to support its safety and effectiveness.

However, the 510(k) Summary does not contain information about a study proving the device meets specific acceptance criteria based on AI performance, human reader improvement with AI assistance, or standalone algorithm performance. The testing discussed is biomechanical tensile strength testing and cadaveric evaluation to assess the device's usability and functionality for its intended surgical uses.

Therefore, I cannot provide a response filling in the requested table and study details as they pertain to AI/algorithm performance. The document focuses on the physical and functional characteristics of a surgical implant, not a diagnostic or AI-driven medical device.

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