(365 days)
When used as a pedicle screw fixation system with CD screws attached to the non-cervical posterior spine, the CD Spinal System is indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system, the CD Spinal System is also indicated for Grade III and IV spondylolisthesis. For this indication only, the spondylolisthesis must be at L5-S1 in patients who are receiving fusions using autogenous bone graft only and who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint for these severe spondylolisthesis cases, the levels of pedicle screw fixation may be L3 to the sacrum.
When used as a posterior non-pedicle screw fixation system, the CD Spinal System is intended for the indications given above as well as spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumor resection, and unsuccessful previous attempts at spinal fusion. For non-pedicle screw use, the levels of fixation for the CD Spinal System are T1 to sacrum, with the screws limited to sacral fixation.
The CD" Spinal System consists of rods, hooks, screws, connectors, and cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD " Spinal System is to provide stabilization during the development of a solid spinal fusion.
The provided document is a 510(k) summary for the CD™ Spinal System, and it describes a medical device (spinal implant system), not an AI/ML device. Therefore, the acceptance criteria and study information requested, which are typically relevant for AI/ML device performance evaluation, are not applicable here.
The document discusses:
- Description of the Device: Components and purpose of the CD™ Spinal System.
- Indications for Use: Specific medical conditions for which the device is intended.
- Substantial Equivalence: The primary basis for FDA clearance, comparing it to a preamendments device.
- Bridging Data: Mention of clinical data, mechanical testing, and theoretical safety profile analysis used to support substantial equivalence.
It does not contain information on:
- Acceptance criteria in the context of an AI/ML model's performance metrics (e.g., sensitivity, specificity, AUC).
- Any study involving a test set, training set, ground truth established by experts, multi-reader multi-case studies, or standalone algorithm performance.
The FDA 510(k) clearance process for this type of medical device largely relies on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing, biocompatibility testing, material characterization, and sometimes clinical data for specific indications, rather than the AI/ML-specific performance metrics you've asked for.
Therefore, I cannot populate the table or answer the questions as they are designed for an AI/ML device evaluation, which is not the subject of this document.
§ 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.