(160 days)
Spinal Elements' Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. Spinal Elements' Spinous Process Plate System is not intended for stand-alone use.
Spinal Elements' Spinous Process Plate System is comprised of a static plate and a translating plate for posterior fixation of the spine in order to achieve fusion. The plates are available in multiple sizes to accommodate various patient anatomies. Both the static plate and the translating plate present spikes to interface with the bone of the spinous processes. The barrel of the static plate passes through the insert of the translating plate such that, in their final position, the plates surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The spinous process plates are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a nitinol spring conforming to ASTM F2063 and a coating of commercially pure titanium conforming to ASTM F1580. Additionally, the plates feature a titanium coating on their medial surfaces as well as the initial portion of the barrel.
This document is a 510(k) premarket notification decision letter and summary from the FDA for a medical device called "Spinal Elements' Spinous Process Plate System." It does not contain information about the acceptance criteria and study proving device performance as requested, because it is for a physical orthopedic implant, not an AI/software device.
The information provided (e.g., performance data, sample sizes, ground truth establishment) is specific to the evaluation of AI/software devices for regulatory purposes. This document details the regulatory review for a spinal implant, which relies on different types of testing.
Therefore, I cannot fulfill your request for acceptance criteria and study details for an AI/software device based on the provided text.
The document states:
- "No clinical testing was found to be necessary." This indicates that a study demonstrating device performance in a clinical setting (which is where metrics like sensitivity, specificity, or reader improvement would be measured) was not required for the clearance of this specific physical implant.
- Non-clinical performance testing included: Static Compression and Torsion testing per ASTM F 1717, Dynamic Compression Testing per ASTM F 1717, Plate Dissociation per ASTM F1798, Pullout Testing, Particulate Analysis per ASTM F1877, Corrosion testing per ASTM F2129, and Austenitic finish (Af) functional testing. These are engineering and material science tests relevant to a physical implant.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.