(135 days)
The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:
• Diaphyseal fractures of the humeral shaft
- · Proximal humeral fractures with diaphyseal extension
- · Impending pathologic fractures
The Talon™ DistalFix™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:
- A humeral nail with proximal portals for passage of cortical locking screws ● and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
- Cortical locking screws will be provided separately. The cortical locking . screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired.
- A proximal end cap will be provided separately. The end cap prevents ● bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.
ODi-NA will manufacture the implants from implant grade titanium alloy.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "Talon™ DistalFix™ Humeral Nail."
This document primarily focuses on demonstrating substantial equivalence of the humeral nail to a predicate device based on design, materials, manufacturing, sterilization, and mechanical testing. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria, study performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.
Therefore, I cannot populate the table or answer the specific questions related to the acceptance criteria and study that proves an AI/ML device meets those criteria.
§ 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.