(122 days)
The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
The Biomet Microfixation Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years, but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.
The Pectus Blu Support Bar and Stabilizers are made of titanium alloy (ASTM F136) and provided nonsterile for sterilization by the end user.
The provided text describes a medical device, the Pectus Blu Support Bar System, and its clearance process with the FDA. However, it does not contain any information about a study involving an AI device or its performance criteria. The document pertains to a traditional medical implant and its safety and effectiveness testing (mechanical, MR compatibility, biocompatibility).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI device.
The prompt requires information about:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
None of this information is available in the provided text as it relates to an AI/software device. The document focuses on physical device characteristics and regulatory clearance for a metallic bone fixation appliance.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.