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The TAC'pin® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
The TAC'pin® is indicated for synthesis of small bones fragments, in the foot only. Examples include: -Akin type osteotomy -first MP Arthrodesis -phalangeal arthrodesis -small bones osteosynthesis requiring compression.

The TAC'pin® is a self tapping wire. One part K is fixed on a standard surgical power tool equipment and when the threaded wire is introduced and positioned as required, the surgeon has to cut the wire at the bone surface. The lengths of threads available are the following : 15 - 20 - 25 mm.

This document is a 510(k) premarket notification for a medical device called TAC'pin®, a bone fixation wire. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance table, or details regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on:

• Sponsor Identification: NewDeal SA, France.
• Device Identification: TAC'pin®, a self-tapping threaded wire for bone fixation.
• Intended Use: Fixation of bone fractures or bone reconstructions, specifically for synthesis of small bone fragments in the foot only (e.g., Akin type osteotomy, first MP Arthrodesis, phalangeal arthrodesis, small bones osteosynthesis requiring compression).
• Predicate Devices: Sgarlato laboratories Threaded fixation pin (K982931) and Syntec-Taichung Medical Instruments Kirschner wires and Steinmann pins (K983121).
• Substantial Equivalence: The document asserts substantial equivalence based on similar intended use, comparable ranges of sizes and diameters, and the use of titanium alloy (or stainless steel for one predicate, deemed not to have significant consequences on safety or effectiveness).
• FDA Clearance: The letter from the FDA (dated February 1, 2000) confirms that the device is substantially equivalent to legally marketed devices and can be marketed, subject to general controls provisions of the Act.

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