(140 days)
The CANOPY™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impinging the spinal cord.
The CANOPY™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.
CANOPY™ plates and screws are manufactured from titanium or titanium allov. as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent polymer as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.
The provided document is a 510(k) summary for a medical device called the CANOPY™ Laminoplasty Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.
However, the document does not contain information related to an AI/ML device study. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes, data provenance, or details about test sets and training sets for an AI/ML model.
- Information about experts, ground truth adjudication, or multi-reader multi-case studies related to an AI/ML model.
- Any mention of standalone algorithm performance or human-in-the-loop performance with AI assistance.
Instead, the performance data cited refers to "Mechanical testing (static and dynamic compression, static compression bending and expulsion) was conducted in accordance with ASTM F543 and F2193 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004." This indicates physical testing of the implant's mechanical properties, not an AI/ML diagnostic or prognostic study.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies related to an AI/ML device based on the provided text. The document describes a physical medical implant device, not an AI/ML software device.
§ 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.