(33 days)
The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull immobilized following surgery or injury.
This document describes a 510(k) premarket notification for the "ReSOLVE Open Back Halo Ring." The submission aims to demonstrate substantial equivalence to a predicate device, the "ReSOLVE Closed Back Halo Ring (K023959)," and also references the "V1 Halo Ring (K930153)".
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Meets or exceeds requirements of ASTM F 1831-97 for Mechanical Integrity of Halo Rings | ReSOLVE Open Back Ring: Meets or exceeds requirements of ASTM F 1831-97 for Mechanical Integrity of Halo Rings |
| ReSOLVE Closed Back Ring: Meets or exceeds requirements of ASTM F 1831-97 for Mechanical Integrity of Halo Rings |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Non-clinical Tests" and "Laboratory tests confirm," but does not explicitly state the sample size used for the testing of the ReSOLVE Open Back Halo Ring or the ReSOLVE Closed Back Halo Ring. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
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)
This information is not provided. The study is a non-clinical, mechanical integrity test, so expert ground truth establishment in a medical diagnostic context is not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the study involves non-clinical mechanical testing, not a human reader assessment.
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 comparative effectiveness study was not done. This device is a medical hardware device (Halo Ring for cervical immobilization), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, a standalone performance test was done, but it's a mechanical performance test, not an algorithm's performance. The "laboratory tests" confirmed that the "new open back design meets the standard for mechanical integrity as the previously approved ReSOLVE Closed Back Ring." This refers to the device's physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this non-clinical test is the standard of ASTM F 1831-97, Section 11. This is a recognized industry standard for the mechanical integrity of Halo Rings. The testing determines if the device meets or exceeds the specified requirements of this standard.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI model.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device and study. The "ground truth" for the performance evaluation is the ASTM standard.
§ 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).