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.

Summary

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March 20, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Stryker GmbH Cindy Leon Staff Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K193366

Trade/Device Name: T2 ICF Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 19, 2020 Received: February 20, 2020

Dear Cindy Leon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193366

Device Name T2 ICF System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Proprietary Name:	T2 ICF System
Common Name:	Smooth or Threaded Metallic Bone Fixation Fastener(21 CFR 888.3040)
Regulation Description:	Smooth or Threaded Metallic Bone Fixation Fastener(21 CFR 888.3040)
Regulation Number:	21 CFR 888.3040
Product Code:	HWC
Device Class:	Class II
Sponsor:	Stryker GMBHBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Cindy LeonStaff Specialist, Regulatory Affairs325 Corporate DriveMahwah, NJ 07430Phone: 201-831-5374Fax: 201-831-6500
Date Prepared:	December 03, 2019
Primary Predicate:	Synthes (USA) 6.5mm Midfoot Fusion Bolt: K081071
Additional Predicate:	Wright Medical Technology, Inc. SALVATION Midfoot Nail:K180024

510(k) Summary

Description

This Traditional 510(k) premarket notification is being supplied to the U.S. FDA to gain clearance to market the T2 ICF System. 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. The use of this subset of the

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VariAx 2 bone screws with the T2 ICF System does not alter the intended use, indications for use, or overall function of the VariAx 2 bone screws.

Lastly, the T2 ICF System will be used with several existing Class I 510(k) exempt devices for various orthopedic purposes.

Intended Use

The T2 ICF System is intended for internal bone fixation.

Indications for Use

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

Summary of Technologies

A comparison of the systems demonstrated that the subject T2 ICF System is substantially equivalent to the previously cleared predicate Synthes (USA) 6.5mm Midfoot Fusion Bolt (K081071) and the Wright Medical Technology, Inc. SALVATION Midfoot Nail (K180024) regarding their intended use, indications for use, technological characteristics (design features, material and performance), as well as underlying operational principles.

Overall, the subject device and the predicate devices share many of the same technological characteristics including:

Intramedullary nailing system intended to provide fracture fixation and alignment of the foot
Nail design (available in various size configurations) and material "(titanium alloy – Ti6Al4V ELI per ASTM F136)
- Synthes (USA) 6.5mm Midfoot Fusion Bolt offered in both titanium alloy and stainless steel variants

The following technological differences do exist between the subject and predicate devices:

. Fixation technology
Nail diameter size offerings

These differences have been addressed through performance testing, which demonstrates that the subject device is as safe and effective as the predicate devices.

Non-Clinical Testing

The following bench testing was conducted to determine substantial equivalence between the subject device and the primary predicate Synthes (USA) 6.5mm Midfoot device:

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l . Biocompatibility evaluation per ISO 10993-1 and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing per ISO 10993-5, ISO 10993-12, ISO 10993-18.
1. Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72 was used for pyrogenicity testing to achieve an Endotoxin limit of <20 EU/Device.
1. MR Compatibility:
- Radio frequency (RF)-Induced heating per ASTM F2182 a.
- Magnetically Induced Displacement Force per ASTM F2052 b.
- Magnetically Induced Torque per ASTM F2213 C.
- d. MR Image Artifacts per ASTM F2119
1. Dynamic Cantilever Bending Test
Static Axial Load to Failure Test 5.
1. Targeting Device Accuracy Testing

The results of the testing demonstrated that the subject device is substantially equivalent to the marketed predicate device.

Clinical Testing

No clinical testing of the T2 ICF System has been conducted.

Conclusion

The subject T2 ICF System is substantially equivalent to the primary predicate Synthes (USA) 6.5mm Midfoot Fusion Bolt (K081071) and the additional predicate Wright Medical Technology, Inc. SALVATION Midfoot Nail (K180024) identified as part of this premarket notification.

Regulation Number and Section

§ 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.