(60 days)
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration 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. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The ABC Cervical Plating System consists of two spinal implant components: bone plates and self-locking bone screws. The implants are manufactured from titanium alloy, Ti6Al4V (according to ISO 5832/3) and are provided non-sterile. The specialized ABC instruments are made primarily of surgical grade stainless steel (according to ISO 7153/1) and are hand-held, re-usable devices.
This document is a 510(k) summary for the ABC Cervical Plating System, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, it does not contain the information requested in the prompt.
Specifically, the document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant system, rather than presenting performance data from a clinical or analytical study to assess against acceptance criteria for an AI/ML system.
Here's why the requested information cannot be extracted:
- No AI/ML device: The product described is a physical medical device (cervical plating system), not an AI/ML diagnostic or prognostic tool.
- No acceptance criteria for AI/ML: Since it's not an AI/ML device, there are no specific acceptance criteria for metrics like accuracy, sensitivity, specificity, etc., which are common for AI/ML devices.
- No study data for AI/ML performance: The "PERFORMANCE DATA" section states "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. The ABC implants subject to this 510(k) submission, however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy." This refers to mechanical and material testing, not the type of studies (e.g., clinical trials, reader studies) that would generate the requested AI/ML performance metrics.
- No information on sample size (training/test sets), expert ground truth, adjudication, or MRMC studies: These are all concepts relevant to the evaluation of AI/ML algorithms and are not present in this document, as it deals with a traditional medical device submission.
In summary, the provided text does not contain any of the information requested about acceptance criteria and study data for an AI/ML 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.