(84 days)
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:
- . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- . Spondylolisthesis
- Spinal Stenosis .
- Tumors .
- Trauma (i.e. fracture) .
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
The provided document is a 510(k) Summary for the SpineSmith Cequence Anterior Cervical Plate System. This document describes a medical device, specifically a spinal implant, and its mechanical testing for substantial equivalence to a predicate device.
Here's an analysis of the document regarding acceptance criteria and a study proving the device meets them, based on the provided questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device based on mechanical testing. | "Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device." (Page 2) |
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 "Mechanical test results" but does not specify the sample size used for these mechanical tests. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) for a spinal implant, the "data" would likely refer to physical testing of components and assemblies.
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 question is not applicable to this type of device and study. The "ground truth" for mechanical testing of a spinal implant is typically established by engineering standards and validated test methods, not by expert consensus in the medical field.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human assessment or a diagnostic device.
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 is a spinal implant, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a spinal implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on established mechanical engineering standards and validated test methodologies for spinal implants. The goal was to show "substantial equivalence" to a predicate device, meaning its mechanical properties and safety profile are comparable.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of device and study.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.