(265 days)
The Rx-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies. The selection of the appropriate type of fixator is left to the discretion of the type of fracture and patient's and patient's anatomy.
The subject RX-FIX Minirail External Fixator is a stable solution for fractures and for lengthening of small bones. It is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The RX-FIX allows for variable pin placement in transverse and frontal planes to simplify external fixation applications on several surgical procedures including: fusions, corrective osteotomies, and fracture fixation. The pin clamp allows for both compression and distraction of the pins.
This document is a 510(k) premarket notification for the RX-FIX Mini Rail External Fixator. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics, rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or F1 score.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert involvement, and ground truth establishment is not available in the provided text, as these are typically associated with performance studies for software devices or diagnostics.
The document explicitly states:
- (b)(1). Substantial Equivalence Non-Clinical Evidence N/A
- (b)(2). Substantial Equivalence Clinical Evidence N/A
This indicates that no dedicated performance study (clinical or non-clinical) was conducted or presented to the FDA for this 510(k) submission, as the determination of substantial equivalence was based on technological characteristics and intended use being similar to a legally marketed predicate device (K051017: R-X-FIX Eternal Fixator).
Thus, I cannot provide the requested information.
§ 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.