(28 days)
The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets requirements of ASTM F 1831-97 for Mechanical Integrity of Cranial Traction Tongs | Meets requirements of ASTM F 1831-97 for Mechanical Integrity of Cranial Traction Tongs. Laboratory tests confirm the new nonconductive design meets this standard. |
| Substantial equivalence to predicate device (JTongs Traction Tongs) for indications of use and function. | The ReSolve Tongs are similar to the predicate device JTongs in function and indications for use and are substantially equivalent. |
| Electrical safety (nonconductive) | Nonconductive design. |
| Sterility | EtO Sterilized. |
| Imaging Compatibility | Compatible with X-ray, CT, MR imaging. (Predicate was compatible with X-ray, CT). |
2. Sample size and data provenance:
No human or patient data was used in this evaluation. The "sample size" refers to the tested tongs. The description indicates "Laboratory tests" without specifying the number of tongs tested. The provenance is likely from the manufacturer's internal testing facilities.
3. Number of experts and their qualifications:
Not applicable. This device is a mechanical tool, and its performance was evaluated through a non-clinical, objective standard (ASTM F 1831-97), not by expert interpretation.
4. Adjudication method:
Not applicable. The evaluation was based on meeting a pre-defined objective standard (ASTM F 1831-97), not on subjective assessment requiring adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is a mechanical device, not an AI or imaging diagnostic tool that would involve human readers.
6. Standalone (algorithm only without human-in-the-loop) performance:
The device's performance was evaluated in a standalone manner against the ASTM F 1831-97 standard. This is akin to a "standalone" evaluation for a mechanical device.
7. Type of ground truth used:
The ground truth was established by the ASTM F 1831-97 standard for Mechanical Integrity of Cranial Traction Tongs. This is an objective, standardized test method defining acceptable mechanical performance.
8. Sample size for the training set:
Not applicable. This is a mechanical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There was no training set for this mechanical device.
§ 882.5960 Skull tongs for traction.
(a)
Identification. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.(b)
Classification. Class II (performance standards).