Both articles are available with a head diameter of 2.51 mm, the Pin is available with overall length of 3.65mm (pin length 2.65mm) and the Tac with a length of 3.5mm (2.8mm)

Tacs and Pins are delivered non sterile.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving device performance for the Meisinger Tacs and Pins.

This 510(k) submission (K130682) is for a medical device (Tacs and Pins) that is seeking clearance based on substantial equivalence to existing predicate devices. In such cases, the FDA often does not require new clinical studies if the device's technological characteristics and intended use are similar enough to already-cleared devices.

The key statement in the document that explains this is:

"Clinical Testing: Not applicable"
"Based on the information provided in the summary we conclude that the Meisinger Tacs and Pins are substantially equivalent to the legally marketed predicate devices described."

Therefore, I cannot provide the requested information as it is not present in the provided text.

To directly answer your numbered points based on the absence of this information:

A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data from a study is reported as clinical testing was deemed not applicable for this substantial equivalence submission.
Sample size used for the test set and the data provenance: Not applicable. No test set was used as no clinical study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for a test set as no clinical study requiring such a test set was conducted.
Adjudication method for the test set: Not applicable. No test set requiring adjudication was used.
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 not an AI-powered diagnostic tool, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, and no standalone performance study was conducted.
The type of ground truth used: Not applicable. No ground truth was established as no clinical study was conducted.
The sample size for the training set: Not applicable. This device is not an algorithm, and no training set was used.
How the ground truth for the training set was established: Not applicable. No training set was used.

Summary

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K130682

510(k) Traditional Meisinger Tacs and Pins

Section #5

510(k) Summary

AUG 1 3 2013

Name of Submitter:	Hager & Meisinger GmbHHansemannstraße 1041468 Neuss, GermanyPhone: (0049) 2131 2012-0Fax: (0049) 2131 2012- 222
Contact Person:	Wiebke StoltenManagement product approval and productvalidation (Regulatory Affairs)wiebke.stolten@meisinger.de
Date Prepared:	04/26/2013
Trade Name:	Meisinger MEITAC, Meisinger Master-Pin-Control
Common Name:	Tacs (MEITAC- Kit), Pins (Master-Pin-Control-Kit)
Classification Name:	Screw, Fixation, Intraosseous
Product Code:	DZL
Regulation No:	872.4880
Class:	II
Panel:	Dental
Predicate Devices:	K092855 Miltex® Membrane Tack KitK973180 IMTEC Bone Tac
Device Description:	The Meisinger Tacs and Pins consist of titaniumalloy Grade 5. The Meisinger Pins are a Tac-equivalent with an extra mini- thread.Both articles are available with a head diameter of2.51 mm, the Pin is available with overall length of3.65mm (pin length 2.65mm) and the Tac with alength of 3.5mm (2.8mm)Tacs and Pins are delivered non sterile.

Meisinger Tacs and Pins 510(k) Traditional

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K130682

510(k) Traditional Meisinger Tacs and Pins K130682

Section #5

510(k) Summary

Tacs and Pins are used for the fixation of Intended Use: (resorbable membranes nonmembranes resorbable membranes) to the bone structure.

Tacs and Pins are intended for single use only.

The Meisinger Tacs and Pins have the same Technological Characteristics: intended use and are substantially equivalent to the legally marketed predicate devices in the United States. The screws use the same biocompatible materials

meeting the requirements from ASTM F136 as the predicated devices.

The design is similar, at least equivalent to predicated devices:

All products have comparable dimensions and design and the intended use is equivalent.

Clinical Testing: Not applicable
The function and intended use, material, possible Conclusion: product have been evaluated as acceptable and equivalent to predicated devices.

Based on the information provided in the summary we conclude that the Meisinger Tacs and Pins are substantially equivalent to the legally marketed predicate devices described.

Meisinger Tacs and Pins 510(k) Traditional

Page 5.2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

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

August 13, 2013

Hager & Meisinger GmbH Mr. Wiebke Stolten Management Regulatory Affairs Hansemannstraße 10 Neuss. Germany 41468

Re: K130682

Trade/Device Name: Meisinger Tacs and Pins Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: July 12, 2013 Received: July 16, 2013

Dear Mr. Stolten:

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 - Mr. Stolten

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Reportal?roblem/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 yours.

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130682

510(k) Traditional Meisinger Tacs and Pins K130682

Section #4

Indications for Use Statement

510(k) Number (if known): K130682

Device Name: Meisinger Tacs and Pins

Indications for use:

Tacs and Pins are used for the fixation of membranes (resorbable membranes non-resorbable membranes) to the bone structure.

Tacs and Pins are intended for single use only.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green - S - M 2013.08.07 15:36:42 -04'00

for M. Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Antrol, Dental Devices

510(k) Number: K130682

Meisinger Tacs and Pins 510(k) Traditional

Page 4.1

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.