(87 days)
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discongenic pain with generation of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions through anterior cervical intervertebral body screw fixation. Levels of screw fixation for this indication are from C2 to T1.
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This document is a 510(k) summary for a medical device (ABC Cervical Plating System), which is a premarket submission to the FDA. It does not contain the kind of detailed study information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, etc.) that would typically be found in a clinical trial report or a performance validation study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or expert involvement as requested.
The document primarily focuses on:
- Device Identification: Name, common names, classification, and product codes.
- Intended Use Statement: Clarifying the medical conditions and anatomical levels for which the device is designed.
- Regulatory Actions: FDA's determination of substantial equivalence, general controls, and specific warnings regarding off-label use (pedicular screw fixation).
There is no mention of a study involving device performance metrics against predefined acceptance criteria in the provided text. The substantial equivalence determination by the FDA is based on comparison to legally marketed predicate devices, not on a detailed performance study like what would be described for an AI/algorithm-based 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.