(133 days)
The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles. The system can be used in both adult and pediatric patients. Examples include:
- Metatarsal, metacarpal, or phalangeal fractures and osteotomies
- Lesser metatarsal shortening osteotomies (e.g. Weil)
- Fifth metatarsal fractures (e.g. Jones Fracture)
The ORTHOLOC® 3Di comprises of variety of plates and screws for fixation of bone fragments. The subject device is composed of titanium alloy per ASTM F136. This system consists of plates in left, right, and universal configurations. The plates can feature polyaxial locking holes and compression holes. The plates are provided non-sterile.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for the ORTHOLOC® 3Di Small Bones Plating System, outlining its substantial equivalence to previously marketed devices. It primarily discusses the device's intended use, technological characteristics, and non-clinical and clinical evidence provided for FDA clearance.
The document states:
- (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing and analysis demonstrated substantial equivalence in static and fatigue bending."
- (b)(2). Substantial Equivalence Clinical Evidence: "N/A"
This indicates that the clearance was based on non-clinical performance testing against a predicate device, rather than a clinical study with detailed acceptance criteria, ground truth establishment, or human reader performance evaluations as typically seen for AI/software-as-a-medical-device (SaMD) products.
Therefore, I cannot provide the requested table or details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on this 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.