(72 days)
The M-2 Anterior Plate System is intended for use in:
- Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Burst fractures/ trauma
- Tumor
- Anterior fusion following failed posterior operations
- Unsuccessful previous anterior surgery
- Lordotic deformities of the spine
The intended levels for treatment with the M-2 Anterior Plate System are T3 to L3. In order to treat levels T3 to L3, plate attachment is from T2 to L4. The M-2 Plate System is intended to treat one motion segment per construct.
The M-2 Anterior Plate System is a construct which consists of one M-2 plate attached to the vertebral body by either four M-2 screws or by two M-2 screws and two M-2 bolts. Surgeon preference dictates which type of implant construct is utilized. The components of the M-2 Anterior Plate System have been designed with anatomic limitations in mind.
M-2 PLATES: The M-2 plate is made from ASTM F-136 implant grade titanium alloy. The plate is contoured in two planes to provide a more suitable fit of the thoracic, thoracolumbar and lumbar segments of the spine. Each plate has two sets of nested slots on each end of the M-2 plate. Larger sized M-2 plates contain an additional nested slot centered in the middle of the M-2 plate for graft fixation. Each nested slot allows 15 degrees angulation of a M-2 screw. The letters A and P are etched on the M-2 plate to identify the anterior and posterior portions of the M-2 plate. On the underside beneath the posterior nested slots is a machined groove designed to prevent rotation of the M-2 bolt. M-2 plates are available in six sizes that range from 40mm to 90mm in ten millimeter increments.
M-2 SCREWS: The M-2 screw is made from ASTM F-136 implant grade titanium alloy. The M-2 screw has a cancellous diameter of 4.75mm. The M-2 screw is capable of 15 degrees angulation within each nested slot of the M-2 plate. A M-2 screw may be used in all nested slots of the M-2 plate. The 4.75mm diameter M-2 screws are available in seven lengths which range from 25mm to 55mm in five millimeter increments.
M-2 BOLTS: The M-2 bolt and spherical nut are made from ASTM F-136 implant grade titanium alloy. The M-2 bolt is composed of two parts: a long cancellous section with an integral fixed lower nut and a machine threaded section above the integral nut. A spherical nut secures the M-2 bolt to the M-2 plate. M-2 bolts have a threaded cancellous of 5.50mm. The integral nut portion of the M-2 bolt connects into the machined groove beneath the posterior nested slots of the M-2 plate. A bolt may be used only in the inferior and superior posterior nested slots of the M-2 plate. The M-2 bolts are available in seven lengths that range from 25mm to 55mm in five millimeter increments.
The provided text describes a 510(k) summary for a medical device, the M-2 Anterior Plate System, and its regulatory approval. It does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.
The document pertains to a traditional medical device (spinal implant) and its non-clinical performance data (mechanical testing). Therefore, I cannot generate a response based on your request, as it specifically asks for information related to AI/ML acceptance criteria and studies which are not present in the provided text.
Here's why the provided text is not suitable for your request:
- Device Type: The M-2 Anterior Plate System is a physical surgical implant (plates, screws, bolts), not an AI/ML powered device.
- Performance Data: The performance data described is "Non-Clinical: Static compression bending and torsion... Dynamic bending compression testing," which are mechanical tests for structural integrity of the hardware. This is entirely different from the performance metrics (e.g., sensitivity, specificity, accuracy) and study types (e.g., MRMC, standalone) associated with AI/ML algorithms.
- Regulatory Pathway: The document is a 510(k) summary for substantial equivalence to a predicate device, a pathway for traditional medical devices. It does not mention any AI/ML specific regulatory considerations or guidance.
- Lack of AI/ML Specific Information: There's no mention of algorithms, training sets, test sets, ground truth establishment by experts, adjudication methods, or any other terminology relevant to evaluating AI/ML performance.
If you have a document about an AI/ML powered device, please provide that, and I would be happy to help.
§ 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.