(98 days)
The RESPONSE BandLoc Spinal Fixation 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:
- · Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- 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 scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
- The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.
The Response BandLoc Spinal Fixation consists of a woven band, band clip, metal insert, tulip head and set screw. The metal insert, band, band clip and tulip head are assembled at the manufacturer and provided as a one piece assembly to the user. This tulip head/band assembly and the set screw are packaged in the same box but in separate peal packs. The tulip head assembly mates with a spine system rod and the set screw is tightened in the tulip head assembly securing it to the rod. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium can be utilized. All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances. No accessories are offered with the system.
This document describes the 510(k) summary for the OrthoPediatrics Corp. Response BandLoc Spinal Fixation system. However, the provided text does not contain any information regarding AI/algorithm performance, human reader studies, or ground truth establishment relevant to an AI-powered device.
The document details the device's mechanical, material, and biocompatibility testing to demonstrate substantial equivalence to predicate spinal fixation devices. The acceptance criteria and testing described pertain to the physical medical device, not to an algorithm or AI system.
Therefore, I cannot fulfill your request for information on acceptance criteria and study details related to an AI device based on this input. The input describes a traditional medical device submission, not one that would involve the metrics you've requested.
To answer your request, the input would need to be a regulatory submission for an AI/ML-based medical device.
§ 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.