(483 days)
BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.
BioDuct's Meniscal Fixation Device is an arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture, and is available in sizes ranging from 5 to 14 mm long. The Meniscal Fixation Device is designed to be placed between the synovium and a lesion located in less well vascularized (red-white) areas of the meniscus.
The provided text describes a medical device, BioDuct's Meniscal Fixation Device, and its 510(k) submission. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.
The document discusses:
- Device Description: An arthroscopically implanted, cannulated, bioabsorbable device used with suture for meniscal fixation.
- Indications for Use: Fixation of longitudinal vertical meniscus lesions in the vascularized (red-white) zone, when used with suture.
- Performance Claim: Mechanical testing results indicate the device, when used with suture, improves the 3-month fixation strength of the lesion compared to trephination and suture alone as shown in the canine model.
- Substantial Equivalence: Based on similarities in indications, design, materials, and comparative testing to listed predicate devices.
The request asks for details typically associated with the validation of an AI/ML medical device, which include acceptance criteria, study design parameters (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness studies. None of these details are present in the provided text, as this device is a physical, bioabsorbable meniscal fixation device, not an AI/ML algorithm.
Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details for AI/ML validation) is not available in the given document.
§ 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.