(60 days)
These devices are to be implanted into the long bones for alignment, stabilization, and These devices are to be mapantrauma or disease, the fixation of long bones that have Itsation of nactor of thank by transmy for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur.
The G4 nail is an intramedullary rod used to stabilize fractures of the femur. It may be inserted in an antegrade or retrograde fashion.
The provided text describes a 510(k) Premarket Notification for the G4 Sleeved Nail, a femoral intramedullary rod. In this type of submission to the FDA, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive clinical trials as would be required for a novel device.
Therefore, the document explicitly states:
- Clinical Testing: None provided as a basis for substantial equivalence.
This means that while the device is intended for medical use, the application does not contain information about acceptance criteria or a study demonstrating that the device meets those criteria through clinical performance. Instead, substantial equivalence was established through a comparison to predicate devices, focusing on function, labeling, sizing, and non-clinical testing.
Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies, as these elements were not part of this specific 510(k) submission.
The document highlights:
- Non-Clinical Testing: "Testing determined that G4 Sleeved Nail presented no new risks and were; therefore, substantially equivalent to the predicate device. FEA was done in conformance to ASTM F-1264." This indicates physical and mechanical testing, likely to ensure structural integrity and biocompatibility, but not clinical performance.
To summarize, the request cannot be fully answered because the provided document is a 510(k) summary for a device demonstrating substantial equivalence based on engineering and comparison to existing devices, not a clinical study report with acceptance criteria and clinical performance 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.