(70 days)
The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar and spiral fractures with bone loss, stabilization for bone transport or lengthening and shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal/diaphyseal junction fractures, and acute bone lengthening and shortening.
The Pylon Intramedullary Nail System consists of intramedullary rods and screws for fixation inside the canal of the tibia or femur. The rods are cylindrically shaped and either made of a solid or cannulated construct, depending on the outer diameter of the rod. Rods are available in a variety of diameters and lengths and have holes located in the proximal and distal ends for fixation to bone by means of bone screws. Bone screws are also available in a multitude of diameters and lengths. An end cap is available that screws into the proximal end of the nails to prevent bone ingrowth which may hamper the attachment of extraction instrumentation. All components of the Pylon Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the "Pylon Intramedullary Nail System."
The document is a 510(k) Pre-market Notification for a medical device. This type of submission to the FDA focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed study results on the device's performance against specific acceptance criteria.
The information provided only includes:
- Device Identification and Description: Pylon Intramedullary Nail System, its components, and materials.
- Intended Use/Indications: A list of fracture types and conditions for which the device is intended.
- Manufacturer Information.
- Substantial Equivalence Claim: The device is stated to be substantially equivalent to ACE AIM Titanium Nails.
- FDA Clearance Letter: Confirming the substantial equivalence determination and allowing marketing.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document.
§ 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.