(72 days)
The Reflex™ ACP System and Reflex™ Hybrid ACP System are intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Reflex™ ACP System and Reflex™ Hybrid ACP System are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion, decompression of the spinal cord following total or partial cervical vertebrectomy, spondylolisthesis and spinal stenosis.
This submission is intended to expand the Reflex " ACP System product line by adding the Reflex" Hybrid ACP System, a low profile anterior cervical plate system, intendcd for unilateral fixation. Similar to its predicate device, the Reflex " Hybrid ACP System consists of bonc plates and screws, available in a variety of lengths. The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Reflex™ Hybrid ACP System will be provided non-sterile.
This is a submission for a spinal intervertebral body fixation orthosis, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving device performance with respect to AI/ML metrics (like those used for diagnostic algorithms) is not applicable. The device is a physical medical implant (anterior cervical plate system), and its acceptance is based on manufacturing, material, and design similarity to a predicate device, along with mechanical testing to demonstrate substantial equivalence, rather than performance in a clinical study to detect or classify disease.
Here's why the AI/ML specific questions are not relevant in this context:
- No AI/ML Component: The provided text describes a "Reflex™ Hybrid Anterior Cervical Plate System" which is a physical implant made of titanium alloy for spinal fixation. There is no mention of any software, algorithm, or AI/ML component.
- Device Type: This is a Class II medical device (spinal intervertebral body fixation orthosis), which typically involves verification and validation through engineering testing (e.g., strength, durability, biocompatibility) and comparison to a predicate device for substantial equivalence, not through diagnostic performance studies.
- "Study that proves the device meets the acceptance criteria": For this type of device, the "study" would refer to mechanical and material testing, and comparison of design features and intended use to a legally marketed predicate device. The text explicitly states: "Testing has been conducted demonstrating substantial equivalence to the predicate device."
Therefore, I cannot provide the requested information in the format of the table or answer the specific questions about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to AI/ML product validation, which is not relevant here.
§ 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.