(232 days)
The Signature Orthopaedics NOOSA, NAMBUCCA, and CAIRNS Anterior Lumbar Plate Systems are indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The devices are intended as temporary fixation is achieved. The subject systems are indicated in the treatment of lumbosacral (L I-S I ) fixation for the following indications: degenerative disc disease (DDD)(as define by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
The Signature Orthopaedics' NOOSA, NAMBUCCA and CAIRNS Anterior Lumbar Plate Systems' components are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136.
The NOOSA, NAMBUCCA and CAIRNS Anterior Lumbar Plate Systems are temporary supplemental fixation devices consisting of variety of shapes and sizes of plates and screws. The subject systems are used as an implant for the correction and stabilisation of the lumbosacral spine. The systems provide temporary stablisation and augments the development of a solid fusion. Additionally, the subject systems can be used in conjunction with interbody fusion devices with anterior plate fixation. The subject plates are low profile and anatomically designed to provide optimal fit from anterior, lateral or anterolateral approach. The NOOSA and NAMBUCCA systems feature anti-angulation locking cams to help restrict the angular movement of the screw within the screw holes of the plates.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification clearance letter from the FDA for the "NOOSA Anterior Lumbar Plate System, NAMBUCCA Anterior Lumbar Plate System, CAIRNS Anterior Lumbar Plate System." It discusses the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical performance testing conducted (static/dynamic compression bending, static torsion, screw insertion, screw pull-out, and screw torque to failure testing).
This document pertains to a traditional medical device (spinal plates and screws) and not an AI/ML-driven device. Therefore, the information requested in your prompt regarding AI/ML-specific acceptance criteria, test set details, expert ground truth, MRMC studies, or training set specifics is not available in these pages.
§ 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.