(157 days)
The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
The VAN GOGH Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the VAN GOGH Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable self-tapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.
The provided text describes a medical device, the VAN GOGH Anterior Cervical Plate System, and its clearance through the FDA's 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not involve a study that evaluates device performance against specific acceptance criteria for AI/ML based devices, nor does it typically include details like human reader studies, training set data, or expert ground truth adjudication as would be relevant for such systems.
Therefore, many of the requested sections below cannot be populated from the provided text because the submission is for a physical medical device (an implantable plate system), not an AI/ML-based diagnostic or prognostic tool.
Here's an attempt to answer the questions based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on "substantial equivalence" to predicate devices, rather than meeting specific performance criteria. The acceptance criteria for the mechanical tests were implicitly met by performing "as well as the predicate device."
| Acceptance Criteria (Not explicit as numerical values) | Reported Device Performance |
|---|---|
| Performance "as well as" predicate devices | "The mechanical test results demonstrated that the VAN GOGH Anterior Cervical Plate System performs as well as the predicate device (U&I Corporation: Maxima™ Anterior Cervical Plate System, Synthes: Synthes Anterior Cervical Locking Plate (ACLP) System, Medtronic: ZEPHIR™ Anterior Cervical Plate System, L&K BIOMED: LEXUS Anterior Cervical Plate System, DepuySpine: SKYLINE Anterior Cervical Plate System)." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" in this context refers to mechanical testing of physical implants, not data for an AI/ML model. The study was non-clinical mechanical testing, not involving human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This was a non-clinical mechanical test, not dependent on expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical mechanical test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic or interpretive AI systems, not a physical implantable device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
For the mechanical tests, the "ground truth" would be the direct physical measurements and compliance with ASTM F1717 standards, compared against the predicate device's performance. It is based on engineering standards and comparative mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML 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.