The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked.

The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

. Open and closed tibial fractures
. Pseudoarthrosis and correction osteotomy
. Pathologic fractures, impending pathologic fractures, and tumor resections
. Nonunion and malunion

Device Description

The subject S2 Tibial Nail System, like the predicate T2™Tibial Nail System, is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws and end caps. The S2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be static, dynamical and compression locked.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and supporting studies for device performance beyond a high-level statement. The document describes a Special 510(k) submission for a design modification of a tibial nail system, focusing on material and design changes and comparing it to a predicate device.

Specifically, the text states:
"FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate T2™ Tibial Nail System."

This statement indicates that finite element analysis (FEA) and mechanical testing were performed to show that the modified S2 Tibial Nail System has comparable mechanical properties to the predicate T2™ Tibial Nail System. However, it does not provide:

Specific quantitative acceptance criteria (e.g., minimum bending strength, fatigue life).
The actual results of the FEA or mechanical testing.
Details about the study design, sample sizes, or ground truth establishment.
Information related to expert involvement, adjudication, or comparative effectiveness with human readers.

Therefore, most of the requested information cannot be extracted from the provided text.

Based on the available information:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated (implied to be comparable mechanical properties to predicate T2™ Tibial Nail System)	FEA analysis and mechanical testing demonstrated comparable mechanical properties to the predicate T2™ Tibial Nail System.

Sample size used for the test set and the data provenance: Not provided. The studies mentioned are FEA and mechanical testing, which typically involve simulations and physical tests, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of study (FEA/mechanical testing of an orthopedic implant) does not involve expert review or ground truth establishment in the way clinical diagnostic AI studies do.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is an orthopedic implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The studies mentioned are FEA (an algorithmic simulation) and mechanical testing (a standalone physical test). The results "demonstrate comparable mechanical properties."
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical expert review. For mechanical testing, the "ground truth" would be established by validated test methods (e.g., ISO or ASTM standards) for material properties and device performance.
The sample size for the training set: Not applicable. FEA and mechanical testing do not typically involve 'training sets' in the machine learning sense. FEA models are built based on material properties and design specifications.
How the ground truth for the training set was established: Not applicable. See point 8.

Summary

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APR 2 5 2002

Special 510(k) Summary: S2 Tibial Nail System: Design Modification to the T2™ Tibial Nail System

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677

Contact Person:

Karen Ariemma Regulatory Affairs Specialist

Date of Summary Preparation:

March 28, 2002

Device Identification

Proprietary Name: S2 Tibial Nail Intramedullary Nail, Tibial Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020

This Special 510(k) submission is intended to address a material modification and a design modification of the T2" Tibial Nail System to create the subject device which is referred to as the S2 Tibial Nail System. The material modification involves changing the material from Ti-6Al-4V Alloy to 316L Stainless Steel. The design change for the nail involves changing the cross section, bend angle location and proximal screw hole configuration. There is no change in intended use for the modified device when compared to the previously cleared device.

Intended Use

Statement of Technological Comparison:

FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate T2™ Tibial Nail System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

APR 2 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K021027

Trade/Device Name: S2 Tibial Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 28, 2002 Received: March 29, 2002

Dear Ms. Ariemma:

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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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 yours,

Mark n Melluso

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

Enclosure

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O2100 1 510(k) Number (if known): K

Device Name: S2 Tibial Nail System

Indications For Use:

The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

. Open and closed tibial fractures
. Pseudoarthrosis and correction osteotomy
. Pathologic fractures, impending pathologic fractures, and tumor resections
. Nonunion and malunion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

for Manh N Melhemor
(Division Sign-Off
theses

General, Restorative and Neurological Devices

510(k) Number K021027

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.