(265 days)
The Cardinal Health Trochanteric IM Nail System is intended to provide temporary fixation of the femur for various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), pathologic fractures, and impending pathologic fractures. Fracture types include pertrochanteric fractures, intertrochanteric fractures, basal neck fractures. Long Length Nails: Fracture types include pertrochanteric fractures, subtrochanteric fractures, intertrochanteric fractures, femoral shaft fractures, and basilar neck fractures.
The System consists of titanium alloy intramedullary (IM) nails, locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.
This document is a 510(k) premarket notification from the FDA to Cardinal Health regarding their Trochanteric IM Nail System. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Crucially, this document is for an orthopedic implant (intramedullary nail) and not a medical device driven by artificial intelligence (AI) or software for diagnostic imaging. Therefore, the information requested in your prompt regarding acceptance criteria for AI-driven devices, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training sets is not applicable to this document.
The document discusses:
- Device Name: Cardinal Health Trochanteric IM Nail System
- Regulation Number/Name: 21 CFR 888.3020 / Intramedullary fixation rod
- Regulatory Class: Class II
- Product Code: HSB
- Indications for Use: Temporary fixation of the femur for various open or closed fractures (malunions, nonunions, pathologic/impending pathologic fractures, pertrochanteric, intertrochanteric, basal neck, subtrochanteric, femoral shaft fractures).
- Device Description: Titanium alloy IM nails, locking screws, and end caps; rigid, cannulated, with proximal and distal holes for locking screws.
- Predicate Devices: Stryker Gamma 3 Nail System (K034002) and Emerge Medical IM Nail System & Screws (K141347).
- Performance Data: Mechanical testing according to ASTM F1264-03 and ASTM F543-13e1.
- Conclusion: Mechanical testing demonstrates the device should perform as well as the predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and study proving an AI device meets them based on this document, as it pertains to a different type of medical device.
§ 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.