(30 days)
The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis.
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis, or scoliosis),
- pseudoarthrosis,
- failed previous fusion,
- spinal stenosis.
The Elatus Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an aqunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.
The Elatus Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Elatus Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
The provided text is a 510(k) summary for the Paeon Anterior Cervical Plate System and Elatus Lumbar Plate System. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared predicate devices.
**However, this document does not describe:
- Acceptance criteria in terms of performance metrics for an AI/ML powered device.
- A study proving the device meets specific acceptance criteria using a test set of data.
- Details about sample sizes, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for data-driven performance evaluation.**
This document is a regulatory submission for spinal intervertebral body fixation orthoses, which are physical medical devices (implants for spinal fusion), not AI/ML-powered software devices. The "performance testing" section explicitly states that "The additional components added in this submission do not require additional mechanical testing." and refers to substituting mechanical test data from predicate devices. This is typical for physical devices demonstrating substantial equivalence based on material, design, and manufacturing process similarity to existing devices.
Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML-based device from the provided text. The questions posed in the prompt (e.g., "Number of experts used to establish the ground truth", "MRMC comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document pertains to.
§ 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.