(90 days)
The ASSURE™ 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The ASSURE™ Anterior Cervical Plate System consists of plates used with either standard screws or rigid screws and set screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants are composed of titanium alloy.
The acceptance criteria and study proving device performance are detailed below:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In accordance with ASTM F1717 for static and dynamic mechanical testing | Meets static and dynamic mechanical testing requirements of ASTM F1717 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" in the traditional sense of a clinical or image-based study. The testing performed was mechanical testing, specifically static and dynamic tests, to assess the physical properties of the device. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) is not applicable in this context. The sample size for the mechanical testing is not explicitly stated, but typically involves multiple samples for each test condition as per ASTM F1717.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable. The "ground truth" for mechanical testing is established by the test method (ASTM F1717) and the physical properties observed. There were no human experts establishing ground truth in the context of these mechanical performance tests.
4. Adjudication Method for the Test Set
This question is not applicable. Mechanical testing results are objective measurements and do not require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study conducted was mechanical testing, not a clinical study involving human readers or cases.
6. Standalone Performance Study
Yes, a standalone study was done, but it was a standalone mechanical performance study, not an algorithm-only without human-in-the-loop performance study (which would be relevant for AI/software devices). The device, the ASSURE™ Anterior Cervical Plate System, underwent static and dynamic mechanical testing in accordance with ASTM F1717. This evaluates the intrinsic physical performance of the device itself.
7. Type of Ground Truth Used
The ground truth used was conformance to a recognized standard, specifically ASTM F1717. This standard defines the methodologies and expected performance criteria for static and dynamic mechanical testing of spinal intervertebral body fixation orthoses.
8. Sample Size for the Training Set
This question is not applicable. There was no "training set" as this was mechanical testing of a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there was no "training set." The performance was evaluated against a standardized mechanical testing protocol (ASTM F1717).
§ 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.