(49 days)
The AOS ES™ Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
The AOS ES™ Trochanteric Nail is a Titanium intramedullary nail that is designed to enter the femur through the greater trochanter. It consists of an intramedullary nail. sliding lag screw, anti-rotation screw, locking screws and end cap.
The provided text describes a 510(k) premarket notification for a medical device called the AOS ES™ Trochanteric Nail. This is a submission seeking clearance for a device based on its substantial equivalence to a legally marketed predicate device, not a study proving novel device performance against acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them for the following reasons:
- Type of Submission: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, not on establishing de novo performance criteria or conducting studies to prove a device meets new performance standards.
- Device Type: The device is an "Intramedullary Fixation Rod" for orthopedic use. Performance is typically evaluated through mechanical bench testing and comparison to existing, already cleared devices, rather than through clinical studies with complex statistical endpoints like those for diagnostic algorithms.
- Content: The summary explicitly states: "Information presented supports substantial equivalence of the AOS ES™ Trochanteric Nail to the predicate device. The proposed nail has the same indications for use, is similar in geometry and design, has the same fundamental technology and is made of the same material (ASTM F136) as the predicate device. The ES Trochanteric Nail was tested against the predicate device through a bench bending analysis as well as a dimensional comparison. The testing resulted in substantial euqivent strength and geometry between the ES trochanteric nail and the short trochanteric nail." This highlights that the "study" was a bench test for equivalence, not a performance study against specific acceptance criteria for aspects like accuracy, sensitivity, or human reader improvement, as would be relevant for a diagnostic or AI-driven device.
Given this, I cannot fill in the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these types of studies and information are not present in the provided 510(k) summary for this orthopedic implant.
§ 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.