The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The subject device is indicated for femoral fracture fixation, which may include the following:

Open and closed femoral fractures .
. Pseudoarthrosis and correction osteotomy
Pathologic fractures, impending pathologic fractures, and tumor resections ●
Supracondylar fractures, including those with intra-articular extension ●
Ipsilateral femur fractures ●
Fractures distal to a hip joint ●
Nonunions and malunions
Reconstruction

Device Description

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar is available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "T2 Supracondylar Nail System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. It does not typically contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies (MRMC) in the way that an AI/ML software device would.

The information provided focuses on the device description, intended use, and substantial equivalence to a predicate device based on design and function, not on performance against specific metrics or a clinical study evaluating its effectiveness in a quantitative manner as would be expected for software or diagnostic devices.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's how the information that is available could be presented:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided documents, as this is a 510(k) for a physical implant based on substantial equivalence, not a software performance study. The implicit "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The primary "performance" reported is its intended use to "provide strong and stable internal fixation with minimal soft tissue irritation." This is a qualitative statement of its function, not a quantitative performance metric.

Acceptance Criteria	Reported Device Performance
Not Applicable - 510(k) for substantial equivalence of a physical implant.	"provide strong and stable internal fixation with minimal soft tissue irritation." (Based on intended use and comparison to predicate device)

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

Sample Size for Test Set: Not applicable. No test set for performance evaluation is described. The 510(k) relies on comparison to a predicate device, not empirical testing data against a defined test set of cases.
Data Provenance: Not applicable. No data or specific test cases are mentioned.

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

Number of Experts: Not applicable. No ground truth establishment for a test set is described.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. No test set is described.

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: No. This device is a physical intramedullary nail, not an AI-assisted diagnostic tool or software.
Effect Size: Not applicable.

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

Standalone Performance Test: No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: Not applicable. The FDA's substantial equivalence determination for this device is based on its design, materials, and intended use being similar to a legally marketed predicate device, not on specific ground truth data for a performance study.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide regarding "acceptance" for market entry:

Mechanism of Acceptance: Substantial Equivalence to a Predicate Device (T2 Supracondylar Nail System is substantially equivalent to a previously marketed intramedullary nail system).
Basis for Substantial Equivalence: Similarities in design (one-piece round profiled shaft, cannulated, closed-section, proximal rounded end), available dimensions (lengths, diameters), and components (intramedullary nails, locking screws, condyle screws, condyle screw nut, end cap), as well as the intended use (internal fixation) and indications for use (various femoral fractures, pseudoarthrosis, osteotomy, pathologic fractures, etc.).
Regulatory Outcome: FDA found the device substantially equivalent, allowing it to be marketed.

Summary

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

T2 Supracondylar Nail System

K023267
page 1 of 1 510(k) Premarket Notification

510(k) Summary for the T2 Supracondylar Nail System

Proprietary Name: Common Name: Classification Name and Reference

Regulatory Class: Device Product Code: For Information contact:

DEC 1 1 2002 T2 Supracondylar Nail System Intramedullary Nail Intramedullary Fixation Rod 21 CFR 8888.3020 Class II 87 HSB Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 831-5718 Fax: (201) 831-6038 September 26, 2002

Date Summary Prepared:

Description:

Intended Use:

The subject T2 Supracondylar Nail System is an internal fixation system comprised of intramedullary nails and the related locking screws, a condyle screws, a condyle screw nut and an end cap. The subject device is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

Substantial Equivalence:

The design and function of the T2 Supracondylar Nail is substantially equivalent to that of the predicate device. Both the subject and predicate systems offer nails in varving lengths, and offer a combination of locking screws, condyle screws, a condyle screw nut and an end cap.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles facing to the right, with wavy lines below them. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2002

Ms. Karen Ariemma Regulatory Affairs Specialist Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401

Re: K023267

Trade Name: T2 Supracondylar Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 17 ,2002 Received: September 30, 2002

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

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

Page 2 - Ms. Karen Ariemma

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 1 of 1

510(k) Number (if known): Ko23267

Device Name: pracondy for Noil S

Indications For Use:

Intended Use

Indications for Use

The subject device is indicated for femoral fracture fixation, which may include the following:

Open and closed femoral fractures .
. Pseudoarthrosis and correction osteotomy
Pathologic fractures, impending pathologic fractures, and tumor resections ●
Supracondylar fractures, including those with intra-articular extension ●
Ipsilateral femur fractures ●
Fractures distal to a hip joint ●
Nonunions and malunions
Reconstruction

h. Mark n. Millican

ivision Sign-Off rative Division of C. P.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

00:03

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.