(111 days)
Fracture reduction and external fixation for treatment of distal radius fractures.
The WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction frame (fixator), application instrumentation and skeletal fixation pins. The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or clinical trial data.
The document is a 510(k) summary for a medical device called the "WristJack System (remanufactured)". This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting clinical study results to prove performance against specific acceptance criteria.
Here's why the requested information cannot be found in the provided text:
- Acceptance Criteria and Device Performance: The document explicitly states "No performance standards exist for this device." and primarily discusses the device's technological characteristics and its similarity to a predicate device. It doesn't present any performance metrics or acceptance criteria for those metrics.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Because no performance study is described, all these related details are absent from the text. The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often through comparisons of materials, design, and intended use, rather than new clinical outcome studies.
In summary, the provided document is a regulatory filing focused on substantial equivalence, not a clinical study report. Therefore, it does not contain the information requested about acceptance criteria and device performance studies.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.