(41 days)
The Normed Compression Bone Screw System intended for use for fractures or arthrodesis of carpals and metacarpals, radial head and radial stolid fractures, metatarsal fractures and osteotomies of the forefoot and intra- artcular arthrodesis in the wrist, pseudo-arthrosis, degenerative alteration and corrective osteotomies aiming to functionally stable osteosynthesis such as, but not limited to scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger eng and metacarpal joints and fractures of ulna head and radius head.
The Normed Compression Bone Screw System is a headless screw with double self-tapping cancellous bone thread that is designed for dynamic adjustable intarfragmentary compression purposes. The pitch of the thread in the proximal segment is smaller than the thread pitch at the distal end. The compression force is produced due to the difference in pitch between the distal and proximal segments. The Normed Compression Bone Screw System consists of three systems. Mini System 1.5. Standard System 2.0 and High Compression System 2.0. The Mini System 1.5 may be placed using an open approach with the use of a target bow device for placement of the screw. The Standard System 2.0 and High Compression System 2.0 are cannulated and may be placed through percutaneous screw placement using K-wire as a guide in minimize the incision. All three systems are available in10 through 30 mm length.
The provided text is a 510(k) summary for a medical device called the "Normed Compression Bone Screw System." It describes the device, its intended use, and the FDA's determination of substantial equivalence. However, it does not contain any information about acceptance criteria, performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) device performance.
Therefore, I cannot fulfill your request for the detailed table and study information because the input document does not provide the necessary data.
To clarify, here's what the document does contain:
- Identifies the device: Normed Compression Bone Screw System (bone fixation plate/screw).
- Device classification: Class II, 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories).
- Intended Use/Indications: Fractures or arthrodesis of various bones (carpals, metacarpals, radial head, metatarsals, etc.) and corrective osteotomies.
- FDA determination: Substantial equivalence to a legally marketed predicate device.
- Contact information for the manufacturer.
It does not include:
- A table of acceptance criteria.
- Reported device performance data against acceptance criteria.
- Details of any study (sample size, data provenance, ground truth, number of experts, adjudication method, MRMC study, standalone study, training set information).
- Any mention of AI, machine learning, or software performance.
§ 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.