(35 days)
The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.
The Compass Universal Hinge is a device used with external fixation devices for the indications listed previously. The Compass Universal Hinge is applied to bones on both sides of a joint to provide active and passive motion of the joint and to restore loss of range of motion due to contracture.
This document is a 510(k) summary for a medical device called the "Compass Universal Hinge," cleared in 1997. It describes the device, its indications for use, and claims substantial equivalence to existing devices.
The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the input document.
Here's why and what's missing:
- No Acceptance Criteria: The document mentions "improvements that enhance user convenience" but does not define specific performance metrics or thresholds for those improvements or for the device's overall functionality.
- No Study Details: There is no mention of any study conducted to assess the device's performance, clinical effectiveness, or safety. The document primarily focuses on establishing substantial equivalence to predicate devices, which at the time did not always require extensive clinical studies for 510(k) clearance, especially for devices deemed "improvements" in convenience.
- No Data on Performance: Consequently, there are no reported device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC study results.
In summary, based only on the provided text, I cannot answer the questions about acceptance criteria and study details because that information is not present. This type of information would typically be found in a detailed clinical study report or a more comprehensive technical file, not usually in a 510(k) summary from 1997 which primarily focuses on substantial equivalence arguments.
§ 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.