(90 days)
Suture wires and wire loops are indicated for use for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.
Suture wires and wire loops are used for bone fracture fixation during the healing process. These wires are available in multiple diameters and lengths.
The document provided is a 510(k) premarket notification for "Suture Wires and Wire Loops". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of diagnostics or AI-driven systems.
Therefore, many of the requested categories are not applicable to this type of submission.
Here's an breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 and 21 CFR § 58 standards. | "All testing passed." |
| Performance Evaluation (Bending Strength): Substantially equivalent to predicate devices. | "The engineering analysis shows the bending strength of the subject devices is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The performance evaluation was based on an "engineering analysis" and biocompatibility testing, not a clinical test set in the traditional sense. Therefore, there's no data provenance or sample size for a test set in relation to patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No human experts were involved in establishing a ground truth for a test set, as this was not a diagnostic or AI-driven device evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method was used as there was no test set requiring human review.
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. An MRMC study was not conducted. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (suture wires and loops), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the biocompatibility testing, the "ground truth" would be regulatory standards (ISO 10993-1 and 21 CFR § 58). For the performance evaluation, the "ground truth" or reference was the performance of the predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.