(93 days)
PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
OZARK Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
The previously cleared K2M PYRENEES, BLUE RIDGE, OZARK and CAYMAN plate systems consist of a variety of plates and screws designed to provide support across implanted levels of the cervical, thoracolumbar and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, PYRENEES, BLUE RIDGE and CAYMAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.
The provided text does not contain information about acceptance criteria and a study proving a medical AI device meets those criteria. Instead, it describes K2M Inc.'s PYRENEES, BLUE RIDGE, OZARK, and CAYMAN spinal plate systems, which are physical medical devices (spinal fixation systems).
The document discusses:
- Indications for Use for various spinal plate systems.
- The purpose of the submission as establishing an MR Conditional labeling claim for these implants and optionally offering previously non-sterile components as sterile.
- Performance Data related to:
- MR Compatibility testing per ASTM F2503. The text states, "The test results demonstrate that the PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN Thoracolumbar and Buttress Plate Systems performance met the prescribed acceptance criteria."
- Bacterial endotoxin testing (BET) performed in accordance with AAMI ST72:2011. The text states, "The test results demonstrate that the sterile devices met the specified testing limit."
Therefore, I cannot provide the requested table or information regarding acceptance criteria for an AI device. The details provided in the input pertain to the testing of spinal implants.
§ 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.