(30 days)
The EAGLE™ + Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The EAGLE + Anterior Cervical Plate System consists of an assortment of plates and screws. The EAGLE + Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided document describes the EAGLE™ + Anterior Cervical Plate System, a medical device. It does not contain information about software or AI, and therefore, does not include acceptance criteria for algorithm performance, a study proving such criteria are met, or details related to AI/algorithm performance.
The document is a 510(k) summary for a spinal implant system. It discusses:
- Device Description: The EAGLE + Anterior Cervical Plate System consists of plates and screws manufactured from ASTM F-136 implant grade titanium alloy. It also includes Class 1 manual surgical instruments.
- Intended Use/Indications for Use: The system is for anterior cervical intervertebral body fixation for patients needing stability after anterior cervical fusion, for levels C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease, re-operation for failed fusion, or instability following surgery for these indications.
- Predicate Device: The EAGLE™ Anterior Cervical Plate System (K040197).
- Performance Data: The document states "Performance data were submitted to characterize the EAGLE + Anterior Cervical Plate System," but it does not detail what that performance data is or what acceptance criteria were used or met. It's highly probable that this performance data would relate to mechanical testing (e.g., fatigue, static strength) suitable for a spinal implant, rather than diagnostic accuracy or algorithmic performance.
Therefore, for your specific questions regarding acceptance criteria for an algorithm/AI and related studies, the provided text does not offer any relevant information.
§ 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.