(77 days)
The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions. The SPIN® SNAP-OFF Screw is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include: -Weil osteotomy - Unicortical small bone fixation. The SPIN® SNAP-OFF SCREW® is indicated for fixing the elective osteotomies in the metatarsal and phalanges of the foot only. Examples include: Weil osteotomy Lesser metatarsal osteotomies
The SPIN® SNAP-OFF Screw is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14 mm.
The provided text is a 510(k) premarket notification for a medical device called the "SPIN® SNAP-OFF SCREW®". It describes the device, its intended use, and a comparison to predicate devices, along with some information about a summary study. However, the document does not contain detailed information about acceptance criteria, comprehensive device performance data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established, as typically required for AI/ML device descriptions.
The study described is a basic assessment of the screw's physical properties against a standard, not a clinical performance study using patient data. Therefore, many of the requested points cannot be answered from the provided text.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary of Studies) |
|---|---|
| Resistance to torsion "in compliance with the selected standard" (French Standard NF-F 90414) | Rupture torque of the SPIN® SNAP-OFF SCREW was found to have a resistance to torsion in compliance with the French Standard NF-F 90414. |
Note: This is an engineering/mechanical acceptance criterion for the device's physical properties, not a clinical performance metric and corresponding acceptance criteria as would be expected for an AI/ML device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Rupture torque of the. SPIN® SNAP-OFF SCREW was compared with requirement of the French Standard NF-F 90414". It doesn't detail how many screws were tested.
- Data Provenance: Not applicable in the context of patient data. The study relates to the physical characteristics of the screw itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical test against a standard, not a clinical evaluation requiring expert ground truth on patient data.
4. Adjudication method for the test set:
- Not applicable. No adjudication process for clinical ground truth is described.
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:
- No. This is a medical device, not an AI/ML imaging or diagnostic product. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the "Summary of Studies": The "ground truth" was the French Standard NF-F 90414 for resistance to torsion. This is a regulatory/engineering standard, not clinical ground truth like pathology or outcomes data.
8. The sample size for the training set:
- Not applicable. This is a physical medical device. The concept of a "training set" for an algorithm does not apply.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) submission for a bone fixation screw, focusing on its substantial equivalence to predicate devices and adherence to an engineering standard. It does not provide the type of performance and study details commonly associated with the evaluation of AI/ML-driven medical devices, which the questions in the prompt are tailored for.
§ 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.