(64 days)
The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
The Stryker Interference Screw Cross Pin System consists of an implant and associated instruments for installation of the implant . The implant consists of two components: an interference screw with cross pin hole, and a cross pin for the interference screw. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin.
This document is a 510(k) premarket notification for a medical device (Stryker Interference Screw Cross Pin System) and describes its substantial equivalence to a predicate device, rather than providing a study with specific acceptance criteria and performance metrics of the new device itself.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.
The core of this document is a regulatory submission for substantial equivalence based on the device's similarity to a previously approved device, not a detailed performance study with quantifiable acceptance criteria.
The available information only states that:
- Device Name: Stryker Interference Screw Cross Pin System
- Intended Use: Surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of various ACL allografts and autografts.
- Predicate Device: Stryker Wedge Interference Screw (#K972233).
- Conclusion: The subject device was shown to have substantially equivalent performance when compared to the predicate device in terms of intended use, safety, and efficacy.
Without a detailed performance study, it's impossible to fill out the table or answer the specific questions about acceptance criteria and how a study demonstrated their achievement.
§ 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.