(36 days)
The Envision™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implant after the attainment of a solid fusion mass. The Envision Anterior Cervical Plate System is intended for use under the following indications:
- Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e., fracture)
- Tumor
- Deformity (i.e., kyphosis, lordosis, and scoliosis)
- Spinal stenosis
- Pseudarthrosis
- Failed previous fusion
The Ortho Development Envision Anterior Cervical Plate System system is a cervical spinal fixation device, which consists of a variety of bone plates and bone screws. Fixation is provided by the insertion of bone screws thought the openings at each end of the plate into the anterior portion of vertebral bodies of the cervical spine. The devices are manufactured from Ti-6Al-4V alloy per ASTM F-136. The Envision Anterior Cervical Plate System functions to provide a means to fuse the cervical spine.
The provided text describes a submission for the Ortho Development Envision Anterior Cervical Plate System. This is a medical device designed for cervical spinal fixation.
Here's an analysis of the acceptance criteria and study information, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biomechanical Performance | Static and fatigue compression testing per ASTM F1717-96 | Similar to the performance of previously cleared spinal systems with similar indications. |
| Static torsion testing per ASTM F1717-96 | Similar to the performance of previously cleared spinal systems with similar indications. | |
| Material Composition | Manufactured from Ti-6Al-4V alloy | Meets ASTM F-136 standard for Ti-6Al-4V alloy. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation describes non-clinical performance testing (mechanical testing), not a test set based on patient data. Therefore, the concept of a "test set" in the context of clinical data provenance or sample size doesn't apply directly here. The testing was conducted on manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The assessment was based on mechanical testing results against an ASTM standard, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
This question is not applicable. The assessment was based on mechanical testing results, not a clinical adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data and conclusion were not needed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for the device's performance was compliance with a recognized industry standard (ASTM F1717-96 for mechanical testing). This standard defines accepted biomechanical performance characteristics for spinal fixation devices.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical implant, not an AI/ML algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above. There is no training set for this type of device.
Overall Context of the Submission:
It's important to note that this document is a 510(k) premarket notification for a medical device. The primary method for demonstrating "substantial equivalence" in a 510(k) is often through comparison to legally marketed predicate devices and non-clinical testing (like biomechanical), rather than extensive new clinical trials, especially when the technology is well-established. The FDA's letter explicitly states that they found the device "substantially equivalent" to predicate devices and that clinical data was not needed for this particular submission.
§ 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.