Search Results

The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

The Spinal Fusion Cage System is single component devices used to restore height of disc space via posterior, lateral, anterior, oblique approach and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

This looks like a 510(k) summary for a medical device (Spinal Fusion Cage System), not an AI/ML device. Therefore, the questions related to acceptance criteria for an algorithm's performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.

The document discusses performance data in the context of mechanical testing for the spinal fusion cages, comparing them to predicate devices. It states:

• Mechanical testing (static axial compression, static compression-shear, static subsidence and dynamic axial compression) was conducted in accordance with ASTM F2077-14 and F2267-04.
• "The subject device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions."

However, specific numerical acceptance criteria (e.g., "subsidence must be less than X mm") and the exact results showing the device meets these criteria are not explicitly detailed in the provided text. The document concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices."

To answer the user's request, I would need a 510(k) summary or similar regulatory document for an AI/ML medical device that includes details about its algorithmic performance evaluation. This document only pertains to a physical implantable device.

Ask a specific question about this device