(12 days)
The SPECTRUM™ Cervical Plating System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/of failed previous fusions.
The SPECTRUM™ Cervical Spinal System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implants for this system are manufactured from Titanium alloy (Ti6Al4V) in conformance with ISO 5832/3 (ASTM F136-98) and are provided non-sterile.
The provided text is a 510(k) summary for the SPECTRUM™ Cervical Spinal System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets acceptance criteria through clinical studies or performance against specific metrics as would be typical for more novel or higher-risk devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of an AI/software device. Specifically:
- No acceptance criteria table or reported device performance for an AI/software component is present.
- No sample size for a test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance study, or ground truth details related to an AI/software evaluation are provided.
- No sample size for a training set or how ground truth was established for a training set is provided.
The "Performance Data" section ([1]Page 2 of 2) explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The modified components conform to ASTM standard F1717, applicable ISO standards, and the CDRH Guidance for Spinal System 510(k)." This indicates that the device's conformity is based on existing mechanical and material standards for spinal systems, not on clinical performance studies proving specific acceptance criteria for functionality like an AI/software device would undergo.
The document discusses substantial equivalence to predicate devices based on design and material conformity to industry standards, not on a detailed analysis of AI performance metrics.
§ 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.