(88 days)
The Cervive Anterior Cervical Plating System is indicated for use in temporarily stabilizing the cervical spine during the development of solid spinal fusion in patients with degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), primary and metastatic malignant tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, and/or spinal cord stenosis.
The Cervive Anterior Cervical Plating System includes plates and expanding screws, both of which are manufactured from titanium alloy (TiAl6V4) that conforms to BS 7252 Part 3 (ISO 5832-3) Metallic Materials for Surgical Implants - specifications for wrought TiAl6V4. The plates range in length and number of holes for screw placement (see heading "Devices to be cleared in this submission" for a complete range of sizes/hole options). The expanding screws are offered in 13, 15 and 16mm lengths. Each screw provides monocortical fixation and consists of two components: the expanding screw and the conus (inner screw).
The provided text describes a medical device, the "Cervive Anterior Cervical Plating System," seeking 510(k) clearance from the FDA. This document focuses on demonstrating substantial equivalence to existing devices through mechanical testing, not on clinical performance or AI algorithm acceptance criteria.
Therefore, the requested information regarding acceptance criteria for an AI device, study details, sample sizes, expert qualifications, and ground truth establishment is not available within the provided text.
Here's why and what information is present:
What's in the document:
- Device: Cervive Anterior Cervical Plating System (a physical medical implant).
- Purpose of Submission: 510(k) premarket notification to establish substantial equivalence to predicate devices (Synthes Cervical Spine Locking Plate K945700 and Blackstone Anterior Cervical Plate K974885).
- Method of Equivalence: Mechanical testing in accordance with ASTM 1717-96. The document states "Protocols and reports from this testing are provided in Section 9." However, the details of these protocols and results are not included in the provided snippets.
- Indications for Use: Temporarily stabilizing the cervical spine for various conditions like degenerative disease, trauma, tumors, deformity, etc.
- Materials: Titanium alloy (TiAl6V4) conforming to BS 7252 Part 3 (ISO 5832-3).
- Components: Plates (various lengths/holes) and expanding screws (13, 15, 16mm lengths).
Why AI-specific information is missing:
- This is a submission for a physical medical implant, not an AI-powered diagnostic or therapeutic device.
- Therefore, concepts like "acceptance criteria for an AI device," "test set sample size," "ground truth experts," "MRMC study," or "standalone algorithm performance" are not relevant to this type of 510(k) filing and are not mentioned.
In summary, the provided document demonstrates how a physical device (Cervive Anterior Cervical Plating System) meets the criteria for substantial equivalence through mechanical testing against a standard (ASTM 1717-96) and comparison to existing predicate devices. It does not contain any information related to AI performance or its acceptance criteria.
§ 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.