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510(k) Data Aggregation
(111 days)
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
This document describes the Zavation Cervical Plate System, a medical device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study for an AI/ML diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, nor does it discuss ground truth establishment, expert adjudication, or reader studies.
Therefore, many of the requested categories related to AI/ML device studies are not applicable to this submission.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from submission) | Reported Device Performance (from submission) |
|---|---|
| Perform as well as or better than predicate devices under ASTM F1717 for: | The mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate devices. |
| - Static compression bending | Demonstrated as well as or better than predicate devices. |
| - Static torsion | Demonstrated as well as or better than predicate devices. |
| - Dynamic compression bending | Demonstrated as well as or better than predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The submission refers to "a worst-case, cervical plate construct" being tested, implying a limited number of constructs rather than a large clinical test set.
- Data provenance: Mechanical testing was performed according to ASTM F1717. This is laboratory-based testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical performance is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert medical review.
4. Adjudication method for the test set
Not applicable. See point 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
Not applicable. This is a spinal implant device, not an AI/ML diagnostic device requiring a reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a spinal implant device, not an AI/ML diagnostic device.
7. The type of ground truth used
"Ground truth" was established through standardized mechanical testing (ASTM F1717) on physical device constructs, measuring parameters like bending strength, torsion stability, and fatigue resistance.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML system that requires a training set. Development and validation rely on engineering design principles and physical testing.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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