(103 days)
The Genesys Spine Binary Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the greatment 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), scoliosis, kyphosis, lordosis, spinal stenos is, or a failed previous spine surgery.
The Genesys Spine Binary Lumbar Plate System consists of an assortment of plates and screws. The Binary Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136.
The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Genesys Spine Binary Lumbar Plate System." This document is NOT about an AI/ML powered device, but rather a traditional spinal implant system. Therefore, the questions regarding AI/ML device performance, such as:
- Acceptance criteria and reported device performance for an AI/ML model
- Sample size and provenance for a test set (in the context of an AI/ML model)
- Number of experts for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth (expert consensus, pathology, outcomes data)
- Training set sample size and ground truth establishment
...are not applicable to this document.
The "Performance Data" section solely outlines nonclinical testing (mechanical strength testing per ASTM F1717) to demonstrate substantial equivalence to predicate devices, focusing on the physical properties of the implant, not the performance of an AI/ML algorithm.
§ 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.