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The "new" TAC'pin® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
The "new" TAC'pin® is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
Fixation of small bone fragments, in long bones or small bones fractures.
Arthrodesis in hand or foot surgery .
Mono or Bi-cortical osteotomies in the foot or hand .
Distal or proximal metatarsal or metacarpal osteotomies .
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc.)

The TAC'pin® is a self tapping threaded wire. The TAC'pin® is designed to be introduced with standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the threaded who 'is 'into one surface. The lengths of threads available are the following prouding partue the boss pin is designed with a variable pitch, for a true and adapted compression.

This document is a 510(k) premarket notification for a medical device called the "TAC'pin®". It focuses on establishing substantial equivalence to previously approved devices, rather than presenting a performance study with specific acceptance criteria and detailed outcomes of a standalone or comparative effectiveness study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not available in these documents.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. Instead, it relies on proving substantial equivalence to existing legally marketed devices. The "performance" reported is that the "new" TAC'pin® is "technically equivalent" to the previously approved TAC'pin® (K993910) and "substantially equivalent" to other threaded fixation pins (K982931, K983121).

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission, not a clinical trial or performance study involving a test set of data. The "test" is the comparison to predicate devices based on design and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of a performance study, is not established here. The assessment is based on regulatory and technical comparison.

4. Adjudication method for the test set

Not applicable. There's no test set in the sense of a data study requiring adjudication.

5. 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. This is a medical device (bone fixation wire), not an AI diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable. Ground truth for a performance study is not used. The basis for approval is substantial equivalence to legally marketed predicate devices, which relies on regulatory precedent and technical comparison of device characteristics.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI-based study.

9. How the ground truth for the training set was established

Not applicable.

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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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