(105 days)
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The RC Lag Screw is also indicated for rotationally unstable fractures.
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers.
The Gamma4 System was previously cleared in K222309, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.
The provided document, K230512, is a 510(k) premarket notification for the Stryker Gamma4 System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than proving the device meets specific performance criteria through clinical studies involving human patients or complex AI algorithm evaluations.
Therefore, the details requested about acceptance criteria and a study proving a device meets these criteria, especially concerning human-in-the-loop performance, AI algorithm training, and expert adjudication, are not present in this document.
The document explicitly states on page 6: "CLINICAL TESTING: Clinical testing was not required for this submission."
The non-clinical testing mentioned is primarily focused on mechanical performance and equivalence to predicate devices, such as:
- Targeting accuracy testing
- Bending Fatigue Strength per ASTM F1264
- Construct Fatigue Strength Testing
- Cut-out testing
- Torsional Stiffness per ASTM F1264
- MR evaluation
These tests are designed to show that the new Gamma4 System performs mechanically similarly to its predecessors, not to assess human or AI performance in a clinical setting.
Consequently, I cannot provide the requested information from the given document, as it does not contain details about a study designed to prove the device meets acceptance criteria related to a human-in-the-loop system, AI performance metrics, or complex clinical outcome data.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.