(39 days)
The RingFIXTM System is intended for:
- fracture fixation (open and closed)
- pseudarthrosis or nonunions of long bones
- limb lengthening by epiphyseal or metaphyseal distraction
- correction of bony or soft tissue deformities
- correction of segmental bony or soft tissue defects
This Special 510(k) Submission is intended to add additional components to the RingFIX™ System
The provided text is a 510(k) Summary and an FDA clearance letter for the SBi RingFIX™ System. It focuses on establishing substantial equivalence to a predicate device and adding new components to an existing system.
Therefore, it does not contain the detailed information requested regarding acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies typically associated with AI/software medical devices.
Medical devices like the SBi RingFIX™ System (a bone fixation appliance) are typically evaluated through different types of studies, such as:
- Mechanical Testing: To assess strength, fatigue, and other physical properties.
- Biocompatibility Testing: To ensure the materials are safe for use in the body.
- Sterilization Validation: To confirm the device can be effectively sterilized.
- Pre-clinical (animal) studies: In some cases, to assess performance in a living system.
- Clinical studies (human trials): For new or high-risk devices, to demonstrate safety and effectiveness in patients.
The 510(k) Summary states: "The Design Control Activities Summary demonstrates that the modified device met all of the pre-determined acceptance criteria. The modified RingFIX™ System will achieve the same stability as afforded by the currently available RingFIX™ System." This indicates that performance data exists, but the specifics are not included in this summary document.
Based on the provided text, I cannot complete the requested tables and sections as the information is not present. The document describes a "Special 510(k) Submission" intended to add additional components to an existing system, rather than a clinical trial for a novel device or an AI-powered one.
§ 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.