The J Tac is intended for use to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

Device Description

The J - Tac is a metal device intended to stabilize a barrier membrane. It is made of Titanium Alloy and supplied non-sterile.

AI/ML Overview

The J-Tac device is a metal device designed to stabilize barrier membranes in oral and dental procedures. Its acceptance criteria and performance were evaluated through non-clinical bench testing.

1. Table of acceptance criteria and the reported device performance:

Test Type	Acceptance Criteria	Reported Device Performance
Compression Force	Unspecified, but tested to demonstrate safe and effective physical properties.	Met the requirements of pre-defined acceptance criteria.
Torsion Test	Unspecified, but tested to demonstrate safe and effective physical properties.	Met the requirements of pre-defined acceptance criteria.

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

The document does not specify the exact sample size for the bench tests (compression force and torsion tests). The data provenance is non-clinical bench testing conducted by Jeil Medical Corporation.

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

Not applicable. The ground truth was established through engineering tests (compression and torsion tests) against pre-defined physical property requirements, not through expert consensus on medical outcomes.

4. Adjudication method for the test set:

Not applicable. The evaluation was based on objective physical property measurements against pre-defined engineering requirements, not on subjective expert review.

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:

Not applicable. This device is a physical medical device (membrane fixation pin), not an AI-assisted diagnostic or treatment tool. Therefore, an MRMC study and AI assistance are not relevant.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device's performance was established through engineering requirements and specifications for physical properties, specifically compression force and torsion strength.

8. The sample size for the training set:

Not applicable. This is a physical medical device, and the evaluation involved non-clinical bench testing, not a training set for an algorithm.

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

Not applicable, as there was no training set for an algorithm. The "ground truth" for the device's functionality was based on established engineering principles and pre-defined acceptable ranges for its physical properties to ensure safe and effective use.

Summary

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#702 Kolon Science Guro-Dona, Guro-Gu, Seoul, 1 Tel : +82 2 850 3500 / Fax : +82

01902 510(k) Summary

FEB - 8 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date: _ October 7, 2010

Company and Correspondent making the submission:

	Company
Name	Jeil Medical Corporation
Address	#702, kolon science valley 2nd811, Guro-Dong, Guro-GuSeoul, Republic of Korea 152-050
Phone	+82 2 850-3544
Fax	+82 2 850-3525
Contact	Jieun Kim

2. Device:

Proprietary Name - J - Tac Common Name - Membrane fixation pin Classification Name - Screw, fixation, intraosseous

3. Predicate Device:

The AutoTac System Titanium Tack, K022790

1. Classifications Names & Citations: DZL, CFR872.4880, Class 2
1. Description:

The J - Tac is a metal device intended to stabilize a barrier membrane. It is made of Titanium Alloy and supplied non-sterile.

1. Indication for use:
  The J - Tac is intended to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

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#702, Kolon Science Valley 2 Guro-Dong, Guro-Gu, Seoul, 152-050 I Tel : +82 2 850 3500 / Fax : +82 2 850 3535

7. Non-clinical testing data

Bench testing was conducted to confirm that the J - Tac has the safe and effective physical properties through the compression force test and torsion test. The testing result meets the requirements of its pre-defined acceptance criteria and intended uses.

8. Review:

The J - Tac has the same device characteristics as the predicate device, the AutoTac; intended use, material, design and use concept are similar.

The differences between them are the dimension of the tack, compression strength, torsion strength, etc.

Based on the comparison of intended use and technical features, the J - Tac is substantially equivalent to the predicate device.

1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation concludes that the J tack are safe and effective and substantially equivalent to predicate devices as described herein.
Jeil Medical Corporation will update and include in this summary any other 10. information deemed reasonably necessary by the FDA.
END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the department's name around the edge. In the center of the seal is an abstract image of an eagle.

Public Health Service

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

Jeil Medical Corporation C/O Ms. Cathy Cambria Arkin Consulting Group 1733 Canton Lane Marietta. Georgia 30062

FEB - 8 201

Re: K101902

Trade/Device Name: J tack Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: January 16, 2011 Received: January 18, 2011

Dear Ms. Cathy Cambria:

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.

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Page 2- Ms. Cambria

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 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.

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S. M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K101902

Device Name: J tack

Indication for use:

Over-The-Counter Use Prescription Use_ OR (Per 21CFR801 Subpart D) (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Veang

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: k10902

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.