(141 days)
The Blustone Synergy Silica System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
The Blustone Synergy Silica System will be offered in parallel and lordotic device configurations of various heights to accommodate patient anatomy. The System of devices may be implanted in the thoracolumbar spine via an anterior approach.
The Blustone Synergy Silica System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided text is a 510(k) summary for the Blustone Synergy Silica System, which is a spinal intervertebral body fixation orthosis. This type of document is for medical device clearance, not for an AI/ML powered device. Therefore, no information is present regarding acceptance criteria, study design for AI evaluation, sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to an AI-powered medical device.
The document discusses non-clinical (mechanical) testing of the physical implant device to demonstrate its substantial equivalence to predicate devices, focusing on:
- Static and dynamic compression testing (ASTM F2077-14)
- Static and dynamic torsion testing (ASTM F2077-14)
- Subsidence testing (ASTM F2267-04(2011))
- Expulsion testing (ASTM Draft Standard F-04.25.02.02)
Since the request is specifically about a study proving an AI-powered device meets acceptance criteria, and this document pertains to a physical implant, I cannot extract the requested information from the provided text.
§ 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.