(262 days)
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radios ), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scollosis, kyphosis or lordosis).
The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium in accordance with ASTM F1472 and ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates and screws to the system. The Pvrenees system components are provided non-sterile.
Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.
The provided text describes the Pyrenees Cervical Plate System, a medical device for spinal fixation, and its substantial equivalence determination by the FDA. However, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or specific performance metrics in the way your request outlines (e.g., in terms of sensitivity, specificity, or AI-assisted improvements).
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for a novel technology (like an AI device).
Therefore, I cannot provide the requested information from the given text. The text primarily addresses:
- Device Description: The Pyrenees Cervical Plate System consists of titanium plates and screws for anterior cervical spine fixation (C2-C7).
- Indications for Use: Degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, tumors, failed previous fusions, and deformity.
- Predicate Devices: K2M Pyrenees Cervical Plate System (K063544, K092474, K111135), DePuy Uniplate (K042544), and Synthes CSLP (K003043).
- Non-clinical Performance Evaluation: The subject Pyrenees plates did not create a new worst-case compared to predicate devices. Predicate plates performed equally to or better than these systems in static compression, static torsion, and dynamic compression in accordance with ASTM F1717. This section confirms mechanical performance, but not against AI-related acceptance criteria.
- Conclusion: The device is substantially equivalent to other marketed devices in design, function, material, and intended use.
In summary, the provided document does not contain the information required to answer your specific questions related to acceptance criteria, study details for meeting those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device.
§ 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.