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510(k) Data Aggregation
(217 days)
COMET ANTERIOR CERVICAL PLATE SYSTEM
The Comet Anterior Cervical Plate System is intended for anterior fixation. immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of disogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Multi-level anterior cervical plates and fixation screws are being added to the previously cleared single-level Comet Anterior Cervical Plate System. The multi-level device additions consist of duallevel plate lengths ranging from 24mm through 48mm and triple-level plate lengths ranging from 36mm through 72mm. Similarly to the single-level devices, the multi-level devices contain barbed plate fixation pins that are permanently affixed to the plate. Plate fixation screws are used to secure the plate to each vertebrae. An additional plate fixation screw diameter is being added in a 3.3mm diameter in 14mm, 16mm and 18mm lengths.
The provided text describes a medical device, the "Comet Anterior Cervical Plate System," and its performance testing in support of a 510(k) premarket notification. However, it does not contain information about a study involving AI, human readers, or image analysis.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate single-level devices. | "multi-level device additions ... are substantially equivalent to the predicate single-level devices of the Comet Anterior Cervical Plate System" |
| Meeting pre-determined acceptance criteria for safety and effectiveness. | "met pre-determined acceptance criteria." and "meet all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness" |
| Acceptable risks evaluated by FMEA. | "The risks associated with use of the new devices were found acceptable when evaluated by FMEA." |
| Performance in static and dynamic axial compression bending. | Bench tests performed in accordance with FDA Guidance and ASTM F1717-04 included "assessments of static and dynamic axial compression bending." |
| Performance in static torsion. | Bench tests performed in accordance with FDA Guidance and ASTM F1717-04 included "static torsion." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench tests for the device, not clinical studies with patient data. Therefore, there is no "test set" in the context of human or imaging data, nor data provenance (country of origin, retrospective/prospective). The tests were performed in a standardized vertebral body model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This was a mechanical engineering bench test, not an evaluation of diagnostic accuracy requiring expert consensus on images.
4. Adjudication Method for the Test Set
Not applicable. (See #3)
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. The provided text describes the mechanical testing of a medical implant, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI algorithm.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be the established engineering standards and specifications against which the device's mechanical performance was measured (e.g., specific load endurance, displacement limits).
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
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