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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.

AI/ML Overview

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 <20 EU/Device as per ANSI/AAMI ST72.	Testing confirmed Endotoxin limit of <20 EU/Device was met.
MR Compatibility:
- Radio frequency (RF)-Induced heating per ASTM F2182	Testing demonstrated MR compatibility for RF-Induced heating.
- Magnetically Induced Displacement Force per ASTM F2052	Testing demonstrated MR compatibility for Magnetically Induced Displacement Force.
- Magnetically Induced Torque per ASTM F2213	Testing demonstrated MR compatibility for Magnetically Induced Torque.
- MR Image Artifacts per ASTM F2119	Testing demonstrated MR compatibility for MR Image Artifacts.
Dynamic Cantilever Bending Test: Maintain structural integrity and function under dynamic bending forces.	Performed, and results contributed to demonstrating substantial equivalence to the predicate device. Specific quantitative results are not provided in this summary.
Static Axial Load to Failure Test: Withstand static axial loads without failure up to a specified limit.	Performed, and results contributed to demonstrating substantial equivalence to the predicate device. Specific quantitative results are not provided in this summary.
Targeting Device Accuracy Testing: Ensure the targeting device provides accurate guidance.	Performed, and results contributed to demonstrating substantial equivalence. Specific quantitative results are not provided in this summary.
Overall Comparison for Intended Use, Indications for Use, Technological Characteristics, and Operational Principles: Be substantially equivalent to predicate devices.	The subject device was determined to be substantially equivalent to the Synthes (USA) 6.5mm Midfoot Fusion Bolt (K081071) and Wright Medical Technology, Inc. SALVATION Midfoot Nail (K180024) in these aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The document describes bench testing for a physical medical device, not a software or AI device that uses a "test set" of data. The "tests" refer to laboratory-based evaluations of material and mechanical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of this document, refers to established scientific and engineering standards and validated testing methodologies described in ISO and ASTM standards. The "experts" involved would be the engineers and scientists conducting and interpreting these standardized tests, whose qualifications are inherent in their ability to perform such evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for expert consensus in cases involving interpretation of medical images or outcomes, which is not relevant to the bench testing described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices; the T2 ICF System is a physical bone fixation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The T2 ICF System is a physical medical device. There is no algorithm or AI component discussed in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the bench testing described in this document is represented by established scientific and engineering standards (e.g., ISO 10993, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119, ANSI/AAMI ST72) and the performance characteristics of the legally marketed predicate devices. The "truth" is whether the subject device performs equivalently to these established benchmarks and predicate devices.

8. The sample size for the training set

This information is not applicable. There is no training set as the device is a physical product, not an AI or machine learning model.

9. How the ground truth for the training set was established

This information is not applicable for the same reason given in point 8.

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