(107 days)
The T2 ICF System is indicated for internal bone fixation of the following conditions and procedures:
- · Neuropathic osteoarthropathy (Charcot)
- · Fracture fixation
- · Osteotomies
- · Non-unions
- · Mal-unions
- · Fusions
The T2 ICF System is a cannulated intramedullary nail system intended for internal fixation and stabilization of various foot instabilities and reconstructions. The T2 ICF system includes sterile packed implants (intramedullary nails and endcaps) available in various diameters and lengths to better accommodate patient anatomy as well as non-sterile instrumentation (targeting devices). The intramedullary nails are assembled with a pre-loaded compression screw, which allows for the nail to compress the bony fragments. The sterile packed intramedullary nails (including the preloaded compression screw) and endcaps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
Additionally, the T2 ICF System will be used with an existing subset of VariAx 2 bone screws (previously cleared under K191412) to achieve fixation of the nail.
Lastly, the T2 ICF System will be used with several existing Class I 510(k) exempt devices for various orthopedic purposes.
This document describes the T2 ICF System, a cannulated intramedullary nail system for internal bone fixation. Since the provided text is an FDA 510(k) summary, it details the substantial equivalence of the device to existing predicate devices, rather than presenting a study proving acceptance criteria for a novel AI device or software. Therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.
Here's an analysis of the provided information within the context of your request, focusing on what is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense for an AI/software device. Instead, it describes bench testing conducted to demonstrate "substantial equivalence" to predicate devices. The performance is reported in terms of successfully meeting the requirements of these tests to prove equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence Bench Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-18. | Testing demonstrated compliance with biocompatibility standards. |
| Bacterial Endotoxin Testing (Pyrogenicity): Achieve an Endotoxin limit of |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.