The T2® Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Device Description

The T2® Recon Nail System is a family of IM (Intramedullary) Nails for various types of femoral fractures. This Special 510(k) submission is intended to address modifications to the T20 Recon Nail System cleared under K032898. The anterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "T2® RECON NAIL SYSTEM LINE EXTENSION," an intramedullary nail for femoral fractures. The submission is for a modification to an existing device, specifically changing the anterior-to-posterior radius of curvature of the nail.

It is crucial to understand that this document does not describe a study involving algorithms, AI, or human readers/experts in the way your prompt asks. This is a mechanical device, and the "study" described is an engineering analysis to demonstrate mechanical safety and anatomical fit. Therefore, many of the requested categories are not applicable to this type of device submission.

Here's an attempt to address your prompt based on the provided text, with clear indications of which categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit from text)	Reported Device Performance
Safety	The modified radius of curvature must not adversely affect the safety of the device.	An "engineering analysis" and "failure mode effect analysis (FMEA)" were performed, indicating that the modified radius does not affect safety.
Effectiveness	The modified radius of curvature must not adversely affect the effectiveness of the device.	An "engineering analysis" was performed, and "prior mechanical testing" which analyzed critical loading areas demonstrated that the proposed radius of curvature does not affect device performance. The device is "substantially equivalent" to predicate devices.
Anatomical Fit	The new radius of curvature must maintain appropriate anatomical fit for its intended use (femoral fractures).	"Potential risks analyzed include anatomical fit of the new radius of curvature." The FMEA and mechanical testing implicitly demonstrated acceptable anatomical fit to allow for intended performance.
Mechanical Strength	The mechanical strength of the T2® Recon Nail with the new radius of curvature must be maintained and suitable for its intended use.	"Potential risks analyzed include... mechanical strength of the T2® Recon Nail." "Prior mechanical testing which analyzed the critical loading areas of the device" demonstrated that the proposed radius of curvature does not affect device performance.
Substantial Equivalence	The modified device (1500mm radius of curvature) must be substantially equivalent to other legally marketed predicate devices in the United States, retaining the same indications for use as the original T2 Recon Nail System and for the predicate Gamma 3 Nail System.	The 1500mm radius of curvature nail design is stated to be "substantially equivalent to other devices currently marketed in the United States." The Gamma 3 Nail System (K034002) is cited as a predicate for the 1500mm radius of curvature.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable (N/A). This was an engineering analysis and mechanical testing, not a clinical study with human subjects or a dataset of images/medical records. The "test set" would be the physical devices or computational models used in the engineering analysis. The document does not specify a number of physical implants tested or simulations run.
Data provenance: N/A. No country of origin is specified. The analysis is based on engineering principles and mechanical testing. The document states it was a "Summary of Data" for an "engineering analysis."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: N/A. No experts were used to establish "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" for mechanical performance is established by engineering principles and physical testing.
Qualifications of experts: N/A.

4. Adjudication method for the test set

Adjudication method: N/A. This concept is typically relevant for studies where human readers independently assess data and their agreement needs to be resolved. This was an engineering analysis.

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

MRMC study done: No. This is a modification to a mechanical implant, not an AI or diagnostic imaging device.
Effect size: N/A.

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

Standalone performance: No. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

Type of ground truth: The "ground truth" implicitly used for this device's performance assessment is based on established engineering principles and validated mechanical testing standards for orthopedic implants, ensuring the device meets predefined material properties, strength, and fatigue resistance under simulated physiological loads. This is distinct from clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Sample size for training set: N/A. There is no concept of a "training set" in the context of this device modification. The design is based on established biomechanical principles and previous designs.

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

How ground truth was established: N/A. (See point 8).

Summary of the "Study" from the Document:

The "study" conducted for this line extension was an engineering analysis combined with a Failure Mode Effect Analysis (FMEA) and prior mechanical testing. The purpose was to demonstrate that a change in the anterior-to-posterior radius of curvature from 2000mm to 1500mm does not negatively affect the safety and effectiveness of the T2® Recon Nail System. The analysis specifically investigated potential risks related to "anatomical fit" and "mechanical strength." The conclusion was that the proposed radius of curvature "does not affect device performance" and that the modified design is "substantially equivalent" to other marketed devices, including its predicate.

Summary

{0}------------------------------------------------

K 102992 '/2

510(k) Summary of Safety and Effectiveness: T2® RECON NAIL SYSTEM LINE EXTENSION

DEC 2 2 2010

Proprietary Name:	T2® Recon Nail System Line Extension
Common Name:	Intramedullary Nail
Classification Name and Reference:	Intramedullary Fixation Rod, 21 CFR §888.3020
Proposed Regulatory Class:	Class II
Product Codes:	87 HSB: Rod, Fixation, Intramedullary And Accessories
For Information contact:	Avital Merl-MarguliesRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365 Fax: (201) 831-3365
Date Prepared:	December 14, 2010

Description:

Intended Use:

The line extension to the T2® Recon Nail System does not alter the intended use of the predicate system as cleared in its' respective premarket notification for use of the subject nail is provided below.

Indications:

Proposed Modification:

The anterior to posterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature. The subject 1500mm radius of curvature nail design is substantially equivalent to

{1}------------------------------------------------

other devices currently marketed in the United States. A predicate device for the 1500mm radius of curvature design is the Gamma 3 Nail System cleared under K034002.

K102992

Summary of Data:

An engineering analysis of the new radius of curvature design has been performed to show that it does not affect the safety and effectiveness of the device. Potential risks analyzed include anatomical fit of the new radius of curvature as well as mechanical strength of the T2® Recon Nail. These risks have been investigated with use of failure mode effect analysis (FMEA) and prior mechanical testing which analyzed the critical loading areas of the device and demonstrate how the proposed radius of curvature does not affect device performance.

{2}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430

DEC 2 2 2010

Re: K102992

Trade/Device Name: T2 Recon Nail System Line Extension Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II -Product Code: HSB Dated: October 7, 2010 Received: October 8, 2010

Dear Ms. Merl-Margulies:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 – Ms. Avital Merl-Margulies

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ais B. Nh
b.

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): KIO2992

Device Name: Line Extension to the T2® Recon Nail System

DEC 2 2 2010

Indications For Use:

The T2® Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neckshaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Page 1 of 1

(Division Sign-Off) for M. Mellekon

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102992

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.