(168 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.
ASSURE®-T Translational Anterior Cervical Plates are anterior cervical plates that allow translation for intraoperative graft compression and postoperative settling. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) using standard ASSURE® screws. The implants are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
The provided text describes a medical device's 510(k) submission, specifically the ASSURE® Anterior Cervical Plate System, and its modification, the ASSURE®-T Translational Anterior Cervical Plates. The document focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study demonstrating the device meets acceptance criteria.
Therefore, much of the requested information cannot be extracted directly from this document, as it pertains to a clinical trial design and execution, which is not present here. The document details the device's indications for use, its classification, and notes that mechanical testing was performed.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical acceptance criteria (e.g., success rates, complication rates) or reported device performance in a clinical setting. It mentions mechanical testing:
| Acceptance Criteria (Implied) | Reported Device Performance (from mechanical testing) |
|---|---|
| Mechanical integrity and strength suitable for anterior cervical plate systems, as per ASTM F1717 and FDA Guidance. | Performance demonstrated "substantial equivalence to the predicate device" in static and dynamic compression bending, and static torsion. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or its sample size. The testing mentioned is mechanical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as no clinical test set or ground truth determination by experts is described.
4. Adjudication method for the test set
Not applicable as no clinical test set or adjudication method is described.
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 device is a physical medical implant (anterior cervical plate), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing performed, the "ground truth" would be the engineering specifications and performance benchmarks established by ASTM F1717 and the FDA guidance for spinal systems. There is no clinical ground truth discussed in this document.
8. The sample size for the training set
Not applicable. The concept of "training set" is relevant for machine learning algorithms, which this device is not. For a physical device, development and design are based on engineering principles and regulatory requirements, not a data training set.
9. How the ground truth for the training set was established
Not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing would be established through engineering design specifications, material properties, and manufacturing quality control, all conforming to established standards and regulations.
§ 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.