(48 days)
The Merete TwistCut™ Snap-Off Bone Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of Small Bone Fragments, Weil-Osteotomy, Mono-Cortical Fixation, Osteotomies and fractures fixation in the foot and hand.
The Merete TwistCut™ Snap-Off Bone Screw is made of Titanium alloy ASTM F136(Ti-6Al-4V ELI), is self drilling and self tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical power equipment. The shaft separates from the screw when the head meets cortical bone. The screw is 2.0 mm in diameter and 11 to 14 mm in length.
The Merete TwistCut™ Snap-Off Bone Screw is a device intended for fixation of bone fractures or for bone reconstruction.
Here’s a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria with corresponding performance results directly. Instead, the "acceptance" hinges on the device being "substantially equivalent" to predicate devices and adherence to relevant standards.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Material Composition: | Merete TwistCut™ screws are produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3. This indicates compliance with recognized material standards for biocompatibility and mechanical properties. |
| Substantial Equivalence: | The FDA reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices (Landos TWIST-OFF™ Screw (K971069) and New Deal SPIN® SNAP-OFF Screw (K011946)) for the stated indications for use. This implies that its anufacturing from similar materials and incorporation of similar technological characteristics meet the performance and safety profiles of the already approved predicate devices. |
| Intended Use: | The device's intended use (fixation of bone fractures or for bone reconstruction, including fixation of small bone fragments, Weil-Osteotomy, Mono-Cortical Fixation, Osteotomies, and fracture fixation in the foot and hand) is considered substantially equivalent to the predicate devices. |
| Technological Characteristics: | The device is described as having similar technological characteristics to the predicate devices, being made of Titanium alloy ASTM F136 (Ti-6Al-4V ELI), self-drilling, self-tapping, with a flat thin head integrated with a short round shaft that separates when the head meets cortical bone. Its dimensions (2.0 mm diameter, 11-14 mm length) are also inherently compared to the predicate. |
| Risk Profile: | The potential risks associated are stated to be "the same as with any metallic internal fixation device," including delayed or nonunion, implant breakage/bending/fracture, metal sensitivity/allergic reaction, and pain/discomfort. The implied acceptance is that these risks are manageable and known, similar to predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not mention a specific "test set" in the context of a clinical study with a defined sample size. The review for substantial equivalence is primarily based on a comparison to predicate devices and adherence to material standards rather than a clinical performance study with human subjects. Therefore, there's no information about sample size or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving "experts" establishing a ground truth for a test set in the context of a clinical performance evaluation. The "ground truth" for the regulatory approval is primarily based on the established safety and effectiveness of the identified predicate devices and compliance with material standards.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set with an adjudication method in the provided documentation.
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 device is a bone screw, not an AI or imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone screw and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this regulatory approval is primarily the established safety and effectiveness profile of the legally marketed predicate devices (Landos TWIST-OFF™ Screw (K971069) and New Deal SPIN® SNAP-OFF Screw (K011946)) and compliance with recognized material standards (ASTM F-136 and ISO 5832/3 for titanium alloy). The FDA's substantial equivalence determination relies on the new device being as safe and effective as the predicate based on technological characteristics and intended use.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the provided information.
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth for it.
§ 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.