The provided text describes a 510(k) premarket notification for a dental product called "Etch Gel" from DMG America, LLC. It focuses on demonstrating substantial equivalence to a predicate device based on physical properties, material composition, packaging/delivery mechanism, and indications for use.

Crucially, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way one would describe for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity, or human expert performance improvement).

This 510(k) is for a physical, chemical product (dental etching gel) and not for a software or AI/ML device. Therefore, the typical "acceptance criteria," "test set," "ground truth," "expert adjudication," or "MRMC study" concepts as outlined in your prompt are not applicable to this type of submission.

The "study" described in this document is a non-clinical performance evaluation focused on demonstrating the chemical composition and physical properties (pH, viscosity, specific gravity) are equivalent to the predicate device.

Here's why the prompt's specific requirements cannot be fulfilled from the provided text:

1. Table of acceptance criteria and reported device performance: This document doesn't list quantitative performance metrics like accuracy or sensitivity for the device's function in a clinical setting against a specified acceptance threshold. It lists physical characteristics.
2. Sample size used for the test set and data provenance: There's no "test set" in the context of an AI/ML model for this product. The evaluation is on the product's physical properties.
3. Number of experts used to establish ground truth and qualifications: Ground truth for a chemical product's physical properties is established through standardized laboratory testing, not expert consensus.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is not an AI/ML device assisting human readers.
6. Standalone performance: This section typically refers to AI algorithm performance without human interaction. Not applicable here.
7. Type of ground truth: The ground truth for this product's evaluation is its inherent physical and chemical properties measured in a lab.
8. Sample size for the training set: Not applicable; there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The "study" presented is a non-clinical performance evaluation comparing the "Etch Gel" device to its predicate device based on fundamental physical and chemical properties to establish substantial equivalence.

Acceptance Criteria (Implied for this type of device, not explicitly stated with thresholds in the summary):

The implied acceptance criteria are that the chemical composition, physical properties (pH, viscosity, specific gravity), product packaging/delivery mechanism, and indications for use of the "Etch Gel" are the same as or equivalent to those of the predicate device (Zenith 40% Phosphoric Acid Gel).

Reported Device Performance:

The document states: "The Etch Gel is either the same as or equivalent to the predicate device in terms of these technological characteristics and non-clinical performance data." This is a qualitative statement of equivalence rather than quantitative performance data against specific thresholds.

No other requested information regarding test sets, experts, adjudication, MRMC, or training sets is available as it pertains to AI/ML device evaluation metrics.

Summary

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510(k) Summary

Date:	July 11, 2013	JUL 1 1 2013
Owner's Name:Address:	DMG America, LLC242 South Dean StreetEnglewood, NJ 07631(201) 894-5500
Contact Person:	Pamela Papineau, RACDelphi Medical Device Consulting, Inc.5 Whitcomb AvenueAyer, MA 01432(978) 772-3552
Subject Device:Trade Name:Common Name:Classification Name:	Etch GelDental etching gelResin Bonding Agent(21 CFR 872.3200, Product Code KLE; Class II)
Predicate Device:Trade Name:	Zenith 40% Phosphoric Acid Gel (Foremost DentalMfg, Inc.)
Common Name:Classification Name:Premarket Notification:	Dental etching gelSealant, Pit and Fissure, and Conditioner(21 CFR 872.3765, Product Code EBF; Class II)K890464

Product Description:

The device described in this 510(k) consists of a water-based gel containing 40% phosphoric acid.

Indications for Use

Preparation of tooth material prior to restoration by etching of the surface.

Substantial Equivalence

Substantial Equivalence for the DMG America, LLC Etch Gel is based upon comparison to the physical properties, material composition, description of product packaging/delivery mechanism and indications for use of the predicate device. Technological characteristics and non-clinical performance data provided in this 510(k) consist of chemical composition. description of product packaging/delivery mechanism, and physical properties measurements (pH, viscosity and specific gravity). The Etch Gel is either the same as or equivalent to the predicate device in terms of these technological characteristics and non-clinical performance data.

Conclusion:

The Etch Gel has been shown to be substantially equivalent in safety and effectiveness to the predicate device.

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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 stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

July 11, 2013

DMG America, LLC C/O Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

Re: K131248

Trade/Device Name: Etch Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 20, 2013 Received: May 01, 2013

Dear Ms. Papineau:

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. Papineau

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 (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 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/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,

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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BMG Asserica, LLC 510(k) Premarket Notileation (Traditions

20 February 2013 Etch Ge

Section 4 - Indications for Use Statement

510(k) Number (if known):

K131248

Device Name: Etch Gel

Indications for Use:

Preparation of tooth material prior to restoration by etching of the surface.

Prescription Use _X (Per 21 CFR 801 Subpart D) OR

Over-the -Counter Use (Per 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)

Mary S. Runner -S

Susan R DOS MA 2013.07.11
15:06:33 -04'00'

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

510(k) Number: 4131248

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.