(224 days)
The DRACO Locking Screws are intended to be used in combination with DRACO Locking plates for adult and pediatric patients as indicated for small bone fracture fixations for use include fixation of fractures, osteotomies, nonunions of the clavicle, scapula, olecranon, radius, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
The DRACO Compression Screws are indicated for fracture fixation of various bones, including, osteotomies in the foot (as Hallux Valgus treatment) or hand, foot or ankle surgery, fixation of bone fragments in long bones or small bone fractures. The size of the chosen screw should be adapted to the specific indication.
The DRACO MetaFuse L Plates and the DRACO MetaFuse BLP Plates are used for adult and pediatric patients as indicated for small bone fracture fixations for use include fixation of fractures, ostectornies, non-unions of the clavicle, scapula, olecranon, radius, ulna, metacarpals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
The DRACO MetaFuse MTP Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, and toes.
Not Found
I am sorry, but the provided text from the FDA 510(k) K163486 document for DRACO Locking Screws, DRACO Compression Screws, and various DRACO MetaFuse Plates does not contain any information about acceptance criteria or performance study results for a medical device that uses artificial intelligence (AI).
The document is a clearance letter and the "Indications for Use" for a range of metallic bone fixation appliances and accessories. It details:
- The 510(k) clearance number (K163486).
- The trade/device names (DRACO Locking Screws, DRACO Compression Screws, DRACO MetaFuse L Plates and BLP Plates, DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates).
- The regulation number and name (21 CFR 888.3030, Single/Multiple Component Metallic Bone Fixation Appliances And Accessories).
- The regulatory class (Class II).
- Product codes (KTT, HWC, HRS, HTY).
- Dates of submission and review.
- The FDA's determination of substantial equivalence to predicate devices.
- General controls provisions and other regulatory requirements.
- Specific indications for use for each device type (e.g., fixation of fractures, osteotomies, non-unions in various small bones for adult and pediatric patients).
- Confirmation that these are Prescription Use devices.
- Information related to the Paperwork Reduction Act.
The document does not describe:
- Any AI functionality.
- Performance metrics (e.g., sensitivity, specificity, accuracy).
- A test set, training set, or data provenance.
- Experts used for ground truth or adjudication methods.
- MRMC studies, standalone AI performance, or types of ground truth used in a study.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of an AI-powered device based on the provided text. The textual content is solely about the regulatory clearance of bone fixation hardware.
§ 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.