(82 days)
The UNIFY™ Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
The UNIFY™ Dynamic Anterior Cervical Plate System consists of plates and variable or fixed angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate allows translation to accommodate bone graft resorption. UNIFY™ Dynamic Anterior Cervical Plate System implants are manufactured from titanium alloy, as specified in ASTM standards F136 and F1295.
This document describes the UNIFY™ Dynamic Anterior Cervical Plate System, a modified anterior cervical plate system intended for spinal fixation. The provided text outlines the device's indications for use, technological characteristics, and basis for substantial equivalence to predicate devices. However, the document does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML performance.
Therefore, many of the requested fields cannot be populated from the provided text, as they pertain to aspects of AI/ML model evaluation that are not relevant to this type of device submission.
Here's the breakdown based on the provided text, and an explanation of why certain fields cannot be filled:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for UNIFY™ Dynamic Anterior Cervical Plate System
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meet ASTM F1717 standards and "Guidance for Spinal System 510(k)s" requirements for static and dynamic compression, static torsion, and static tension. | Performance data demonstrate substantial equivalence to the predicate device. |
| Material Composition | Conform to ASTM standards F136 and F1295 for titanium alloy. | Implants manufactured from titanium alloy, as specified in ASTM F136 and F1295. |
| Design/Dimensions/Intended Use | Similar to predicate devices. | Technological characteristics are similar to predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. |
Explanation: The "acceptance criteria" for this traditional medical device (a spinal plate system) are implicitly met by demonstrating "substantial equivalence" to legally marketed predicate devices through adherence to mechanical testing standards and material specifications. There are no explicit numerical performance metrics like accuracy, sensitivity, or specificity, as those are typical for diagnostic or AI-driven devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a physical medical device (spinal plate), not an AI/ML system that uses a test set of data. The performance testing refers to mechanical laboratory tests, not data analysis.
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)
- Not applicable. This submission is for a physical medical device. "Ground truth" in the context of expert review is not relevant here. The "ground truth" for mechanical testing would be the physical properties and performance of the device under controlled laboratory conditions, as defined by ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this is for a physical medical device and not an AI/ML system requiring expert adjudication of a test set.
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 for a physical medical device. MRMC studies are used to evaluate diagnostic imaging systems or AI tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a physical medical device. "Standalone algorithm performance" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical performance data, the "ground truth" is defined by the ASTM F1717 standards and the "Guidance for Spinal System 510(k)s", which specify the test methodologies and acceptable limits for mechanical properties (e.g., strength, stiffness, fatigue life). The performance of the predicate device also serves as a benchmark for "substantial equivalence."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
§ 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.