(107 days)
This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.
The Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity. The Pectus Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. The device should be removed when remodeling is evident. These devices are offered as flat (unbent) bars requiring intraoperative shaping, or alternatively may be prebent to patient anatomy. These devices are intended to be used in professional healthcare facilities.
The Pectus Support Bar are made of titanium alloy (ASTM F1472) or stainless steel (ASTM F138). The Pectus Stabilizers are made of stainless steel (ASTM F138) or titanium alloy (ASTM F136). The Pectus Support Bar system is provided non-sterilization by the end user.
The provided text is a 510(k) summary for a medical device called the "Pectus Support Bar System." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance, acceptance criteria, or a study proving it meets those criteria, as it's a structural implant and not an AI/ML diagnostic or prognostic device.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as an AI/ML device. The document explicitly states:
- "Clinical data was not required for the determination of substantial equivalence."
- The performance testing described is focused on material properties, mechanical strength, MR compatibility, and biocompatibility, as relevant for an implantable device, not AI/ML performance.
If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the requested information.
§ 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.