(33 days)
The Fixano TWIN FIX wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
The device is a radiolucent external fixator capable of limited range of motion.
The provided FDA filing (K022771) for the Fixano TWIN FIX device does not contain information regarding the acceptance criteria, reported device performance, or any studies proving the device meets acceptance criteria.
The filing is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific performance metrics.
Therefore, I cannot populate the requested tables and information. The document focuses on:
- Device identification: Manufacturer, classification, names, etc.
- Substantial equivalence: Comparing the TWIN FIX to existing devices like the Danek Wrist Fixator.
- Intended Use: Stating the purpose of the device (reduction, alignment, and stabilization of fractures and deformities in the upper extremity).
- Regulatory communication: The FDA's letter confirming substantial equivalence and allowing marketing.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or its provenance.
- The number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how ground truth was established for it.
§ 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.