(227 days)
The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
This document is a 510(k) summary for the Biomet Microfixation RibFix Blu Thoracic Fixation System. It describes a medical device, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.
Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance because the document does not discuss these concepts for an AI/ML device.
Here's why the provided text is not relevant to your request for AI/ML device performance:
- Device Type: The Biomet Microfixation RibFix Blu Thoracic Fixation System is a physical medical device (metallic plates and screws for bone fixation). It is not an AI/ML algorithm or software.
- Performance Data: The document states, "Non-Clinical Performance Data: MRI simulation and physical testing were performed to support the MR Safety Information in the labeling. Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence." This refers to physical and material performance, not algorithmic performance.
- Lack of AI/ML Specifics: There is no mention of algorithms, machine learning, data sets (training or test), ground truth, experts for annotation, or any other terms relevant to AI/ML device evaluation.
If you have a document about an AI/ML medical device, I would be happy to analyze it according to your requested format.
§ 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.