The T2™ Flexible Nail is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. This includes upper extremity fractures of all patients and lower extremity fractures of pediatric or small-statured patients. Specific indications include: - Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and . fibula in pediatric and small-statured patients. - Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm . fractures in all patients.

Device Description

The T2™ Flexible Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design that can be cut to size intraoperatively. The nail is available in eight diameters and two lengths. The nails will be available sterile and non-sterile in titanium alloy and stainless steel.

AI/ML Overview

This document is a 510(k) summary for a medical device called the T2™ Flexible Nail, an intramedullary nail for bone fracture stabilization. It is not an AI/ML device, therefore the typical acceptance criteria and study information for such devices are not applicable.

The document discusses the device's substantial equivalence to predicate devices, which is the basis for its clearance by the FDA, rather than performance against pre-defined acceptance criteria or a clinical study in the context of AI/ML performance metrics.

Therefore, I cannot provide the requested information in the format of AI/ML device performance and study details, as this device does not fall into that category.

Here's a breakdown of why the requested information cannot be generated based on the provided text, related to the typical requirements for AI/ML medical devices:

A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics (like sensitivity, specificity, accuracy, etc.) or acceptance criteria for the T2™ Flexible Nail in the way an AI/ML device would. Instead, it relies on demonstrating substantial equivalence to existing devices.
Sample sized used for the test set and the data provenance: Not applicable. There is no AI model being tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI model, and thus no "ground truth" to establish through expert consensus for a test set. The efficacy of this device is assessed through clinical use of similar devices and potentially mechanical testing, not through expert interpretation of data for model validation.
Adjudication method: Not applicable for the same reasons as above.
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: Not applicable. This is a physical medical device, not an AI diagnostic or aid.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical medical device often comes from clinical outcomes, long-term follow-up, and mechanical testing results, not from expert consensus on interpretations of data for AI model training or testing.
The sample size for the training set: Not applicable. There is no training set for an AI model.
How the ground truth for the training set was established: Not applicable.

The provided document describes a traditional medical device (an intramedullary nail) seeking 510(k) clearance based on substantial equivalence, which is a different regulatory pathway compared to AI/ML devices that often require evidence of performance against specific metrics.

Summary

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K♡2018

510(k) Summary of Safety and Effectiveness OCT 1 0 2008 T2™ Flexible Nail

Proprietary Name:	T2 ™ Flexible Nail
Common Name:	Intramedullary Nail
Classification Name/Reference:	Intramedullary Fixation Rod21 CFR §888.3020
Device Product Code:	87 HSB
Proposed Regulatory Class:	Class II
For Information contact:	Francisco Haro, Senior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493 Fax: (201) 831-6038
Date Summary Prepared:	July 15, 2008

Description:

Indications:

. Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and fibula in pediatric and small-statured patients.
Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm fractures in all patients.

Substantial Equivalence:

The subject system is substantially equivalent to the predicate nailing systems for the stabilization of long bone fractures using a closed technique. The supporting information included in the following pages has sufficiently demonstrated the equivalence of the subject device to its predicates in regards to intended use, design, materials and operational principles.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Howmedica Osteonics Corp. c/o Mr. Francisco Haro Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430

Re: K082018

Trade/Device Name: T2TM Flexible Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 15, 2008 Received: July 16, 2008

Dear Mr. Haro:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K082018

Device Name: T2™ Flexible Nail

Indications for Use:

Specific indications include:

Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and . fibula in pediatric and small-statured patients.
Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm . fractures in all patients.

Prescription Use(Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1
510(k) Number	K082018

Regulation Number and Section

§ 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.