(49 days)
The Synthes (USA) Sterile Sternal Fixation System (SFS) is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes SFS is a system consisting of machined Titanium plates, a quick-release pin, and 3.0mm locking screws. The plates utilize screw fixation to create the construct.
I am unable to find the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies within the provided text. The document is a 510(k) summary for the Synthes Sterile Sternal Fixation System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results or acceptance criteria against specific performance metrics.
The document discusses:
- Sponsor and Device Information: Synthes (USA), Device Name, Classification, Predicate Devices, and Device Description.
- Intended Use: Primary or secondary closure/repair of the sternum following sternotomy or fracture.
- Substantial Equivalence: A statement that comparative information supports substantial equivalence.
- FDA Communication: An FDA letter confirming the 510(k) clearance based on substantial equivalence to predicate devices.
The FDA 510(k) clearance process primarily evaluates new medical devices against predicate devices for substantial equivalence regarding safety and effectiveness, rather than requiring extensive clinical trials with predefined acceptance criteria and performance metrics for the new device as would be seen in a PMA (Premarket Approval) application. Therefore, the detailed study information you're looking for is typically not present in a 510(k) summary.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.