(210 days)
The CanMINI Hand and Foot System is indicated for fixation of small bones and small bone fragments in the hand and foot. The devices are intended to be single-use and sterilized before use.
The CanMINI Hand and Foot System, manufactured by CANWELL MEDICAL CO. LTD., is an orthopedic fixation system designed to stabilize fractures or osteotomies of the small bones in the hand and foot. The system includes a variety of bone plates and screws made from high-quality titanium and titanium alloy, ensuring both strength and biocompatibility. The primary materials used in the CanMINI Hand and Foot System are pure titanium, conforming to ASTM F67 standards, and titanium alloy, conforming to ASTM F1472 standards.
The CanMINI Hand and Foot System consists of multiple components, each designed to address specific clinical needs in orthopedic surgery. The key components are bone plates and bone screws.
The bone plates include straight type bone plates such as models FZSQ01 Ⅰ, FZSQ12, FZSQ38, FZSQ39Ⅰ, FZSQ39Ⅱ, FZSQ39Ⅲ, FZSQ40Ⅰ, and FZSQ40Ⅱ, as well as supporting type non-locking bone plates like models FBC54Ⅰ, FBC54Ⅱ, FBC55, FBC56, and FBC58. Additionally, the system features supporting type locking bone plates including models FBCS29, FBCS57Ⅰ, FBCS57Ⅱ, FBCS59, FBCS60, FBCS86, FBCS87, FBCS88, FBCS89, FBCS96Ⅰ, FBCS96Ⅱ, FBCS99Ⅰ, FBCS99Ⅱ, FBCS132, FBCS134, and FBCS135. The bone screws are also categorized into different types, including metal non-locking bone screws with models FHAQ02 Ⅰ, FHAQ03 Ⅰ, FHAQ06 Ⅰ, metal locking screws with models FHAS04 Ⅰ, FHCS04 Ⅰ, and cannulated screws with model FGJYD Ⅹ. The bone plates and screws in the CanMINI Hand and Foot System come in a range of sizes to accommodate different anatomical and clinical requirements. For example, the 6-hole 1.5mm phalangeal metacarpal locking plate has dimensions of 29.7 mm in length, 4.7 mm in width, and 0.95 mm in thickness, while the 8-hole 2.4mm condylar locking plate has dimensions of 59.0 mm in length, 6.5 mm in width, and 1.4 mm in thickness.
The CanMINI Hand and Foot System is intended for the stabilization of fractures and osteotomies in the small bones of the hand and foot. It provides mechanical support to the bone during the healing process by maintaining proper alignment and stabilizing the fracture site. The system is designed to be used by orthopedic surgeons in various clinical scenarios involving bone fractures, including but not limited to, calcaneal fractures, fracture displacements, and non-union fractures. The clinical benefits of the system include providing critical stabilization and support during the healing of orthopedic fractures. This system aids in the proper alignment of fractured bones, enhances the healing process, and reduces the likelihood of complications such as malunion or delayed union.
The CanMINI Hand and Foot System is supplied in a non-sterile state and must be sterilized before use. It is intended for single use only.
The provided FDA 510(k) clearance letter and summary for the "CanMINI Hand and Foot System" do not describe acceptance criteria for an AI/software device nor a study proving it meets such criteria.
The document discusses a physical medical device (bone plates and screws) used for fixation of small bones, not a software or AI medical device. The "Non-Clinical Testing" section describes mechanical tests performed on the physical hardware components of the system (e.g., axial pullout strength, single cycle bend testing, driving torque), and material characterization tests for the titanium used in these components, against ASTM standards.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, ground truth establishment, MRMC studies, or standalone performance for an AI/software device from the provided text. The document explicitly states "Clinical Testing: Not Applicable." and focuses on the physical and material properties of an orthopedic implant system.
§ 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.