(64 days)
The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radios), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, "Vega™ SPANTM Spinous Process Plate System", consists of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating postoperatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct.
System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
This document describes the 510(k) premarket notification for the Inspan® ScrewLES® Fusion System. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance with performance metrics, or details about the studies involving AI algorithms.
The document discusses the substantial equivalence of the Inspan® ScrewLES® Fusion System to a predicate device, the Vega™ SPAN™ Spinous Process Plate System. It provides information about:
- Indications for Use: Posterior non-pedicle supplemental fixation in the non-cervical spine (T1-S1) for supplemental fusion due to spondylolisthesis, trauma, tumor, degenerative disc disease, or lumbar spinal stenosis.
- Device Description: Consists of varying length/hub diameter plates, set screws, and instruments, manufactured from titanium alloy (Ti-6AI-4V ELI).
- Non-Clinical Performance Testing: Biocompatibility, sterilization, and non-clinical testing data were submitted.
- Clinical Performance Testing: A retrospective review of prospectively collected data by Chin et al. (2020) involving 56 patients treated for degenerative disc disease with lumbar spinal stenosis. This study reported statistically significant improvements in VAS back pain and ODI at 24 months postoperatively.
However, the provided text does NOT include information on:
- Acceptance criteria directly linking to performance metrics. The document states the device was found "substantially equivalent" based on indications, design, materials, function, manufacturing, and performance, but it does not specify quantitative acceptance criteria or detailed performance metrics.
- AI-specific study details. The document describes a medical device for spinal fixation, not an AI/ML-driven device. Therefore, the questions related to AI device performance, sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, and MRMC studies are not applicable to this particular document.
To answer your request, I would need a document related to an AI/ML medical device submission.
§ 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.