(83 days)
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).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in intended use, material, and design of the active part. | The "new" TAC'pin® is technically equivalent to the currently approved TAC'pin® (K993910) and substantially equivalent to predicate devices K982931 and K983121. |
| The design change (decreased proximal diameter) does not affect the "active" part or patient safety. | The diameter of the proximal (non-threaded) part was decreased from 1.7mm to 1.6mm for better adaptation to power drills. This part is cut by the surgeon and does not remain in the patient, thus not impacting the active part or patient safety. |
| Fulfillment of stated Indications for Use. | The "new" TAC'pin® is indicated for fixation of bone fractures or bone reconstructions, with examples including small bone fragments, arthrodesis, osteotomies in hand/foot, and Hallux Valgus treatment. |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.