(56 days)
The Gecko Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
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Spinal trauma surgery, used in sublaminar or facet wiring techniques;
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Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scollosis, kyphosis and spondylolisthesis;
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Spinal degenerative surgery, as an adjunct to spinal fusions.
The Gecko Spinal System may also be used in conjunction with other Ortho Development's spinal rod systems made of similar metals whenever "wiring" may help secure the attachment of the other implants.
The Gecko Spinal System is an implantable device intended to provide immobilization and stabilization of spinal segments. The device consists of an implantable polyethylene terephthalate (PET) braided band with a stiffened guiding section at one end and a metal leader at the other (both removed before final implantation), an implantable grade titanium alloy clamp that mates with 5.5mm diameter rods, and an implantable grade titanium alloy nut that secures the band, clamp, and connecting rod together. All implants are provided sterile for single use only; the implant should not be re-used or re-sterilized under any circumstances.
This document is a 510(k) Premarket Notification from the FDA for a medical device called "The Gecko Spinal System." It is a regulatory approval document and does NOT contain information about a study proving the device meets acceptance criteria derived from AI/machine learning performance.
The content focuses on:
- Regulatory approval: 510(k) clearance, substantial equivalence to predicate devices.
- Device description: Components, materials, intended use, indications for use.
- Performance data (non-clinical): Sterilization (gamma radiation), shelf life (packaging), biocompatibility, and mechanical testing (static and dynamic band tension, axial grip, torsional grip, axial compression). These are standard engineering and material science tests for implantable medical devices, not performance metrics for an AI/ML algorithm.
- Absence of clinical testing: "None provided for basis of substantial equivalence." This explicitly states that no clinical trials were conducted or submitted for this specific 510(k) clearance.
Therefore, I cannot extract the requested information regarding acceptance criteria for an AI-powered device, study details for AI performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI. This information is simply not present in the provided text.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.