AMERICAN DENTAL PRODUCTS ETCH-DETECT by AMERICAN DENTAL PRODUCTS, INC.

The provided text is a 510(k) summary for the "American Dental Products Etch-Detector." It states that the product's efficacy is comparable to or better than other brands on the market, based on "Third party testing." However, it does not provide specific acceptance criteria or details about the study that proves the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not provided in the document. The document only generically states "comparable or better than other brands."
Reported Device Performance: Not provided in a quantifiable manner. It only states "efficacy of our products is comparable or better than other brands."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not provided.
Data Provenance: Not provided. The document mentions "Third party testing" but offers no details about who conducted the testing, where, or when.
Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. The nature of "ground truth" for a device that detects "residual decay (denatured protein) while etching dentine" would likely involve laboratory or clinical assessment of dental surfaces, but no details are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided.

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 "Etch-Detector," which appears to be a chemical indicator or similar tool, not an AI or imaging device that would involve human "readers." The concept of "human readers" improving with "AI assistance" does not fit the description of this product.

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

Not applicable. This is not an algorithm, but a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. If "training set" refers to development or validation testing, no sample size is given.

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

Not applicable.

Summary of what is available from the document:

Device Name: American Dental Products Etch-Detector
Claimed Performance: Efficacy is comparable or better than other brands on the market.
Evidence Basis: "Third party testing."
Safety Information: Contains ingredients proven safe, but Phosphoric Acid Gel can cause blindness if in contact with eyes; requires professional handling with gloves, avoiding contact with skin, tissue gum, and eyes, following instructions and Material Safety Data Sheet.
Indications for Use: To detect residual decay (denatured protein) while etching dentine in the "Total Etch" technique.

Summary

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JUN 10 1999

UN 10 1999

merican Dental Products Inc.

603 B C
Bensenville,

Phone:

Fax:

Image /page/0/Picture/12 description: The image shows the logo for the Dental Manufacturers of America (DMA). The logo is in black and white. The letters "DMA" are in large, bold font, and the words "DENTAL MANUFACTURERS OF AMERICA" are in a smaller font below the letters.

603 B Country Club Drive Bensenville, IL 60106-1329, USA

630-238-0275 Phone: 800-846-7120 630-238-0276

Website: www.Amdental.com E-mail: George@AmDental.com

510 ( K ) SUMMARY: K 991099

The Safe Medical Devices Act of 1990 requires all persons submitting a premarket notification submission to include either (1) a summary of the safety and effectiveness information in the pre-market notification submission upon which an equivalence determination could be based (510(k) summary), or (2) a statement that safety and effectiveness information will be made available to interested persons upon request (510(k) statement). Safety and effectiveness information, that is relevant to an assessment of substantial equivalence. The information could be descriptive information about the new and predicate device(s), or performance or clinical testing information.

In order to comply with the above requirements, we would like to state that our product's efficacy is comparable with other brands which are on the market.

Third party testing shows that the efficacy of our products is comparable or better than other brands which are on the market.

Regarding the safety of the product, please be advised that the product contains ingredients which have been proven to be safe to be used in the dental industry for many years. However a mishandling of Phosphoric Acid Gel, if become in contact with eyes, will cause blindness. Wash immediately eyes with plenty of water and get immediate medical attention. The product must be handled by a dentist professional according with the instructions and Material Safety Data Sheet, wearing gloves, avoiding contact with skin, tissue gum and eyes using normal safe practices in a highly professional manner.

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flore informations regarding the safety of the product are covered in the Material y Data Sheet for American Dental Products Etch-Detector, which copy please find enclosed -

Please be advised that our product American Dental Products Etch-Detect is not ailable on the market as of today, March 25, 1999, yet but we plan to market the

oroduct soon.

The descriptive information presented here satisfy the requirements of the SMDA

of 1990.

Sincerely Yours,

George Nirtog

George Nicolae, Ph.D. President and Official Correspondent AMERICAN DENTAL PRODUCTS INC.

Etchdet7

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1999

George Nicolae, Ph.D. President and Official Correspondent American Dental Products, Incorporated 603 B Country Club Drive Bensenville, Illinois 60106-1329

Re : K991099 American Dental Products Etch-Detector Trade Name: II Requlatory Class: Product Code: EBC May 24, 1999 Dated: Received: May 28, 1999

Dear Dr. Nicolae:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the abreatially 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major be basyos of becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Nicolae

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 441044
Page _ of _

Image /page/4/Picture/2 description: This image contains information about a medical device. The 510(k) number, if known, is K991099. The device name is AMERICAN DENTAL PRODUCTS ETCH-DETECT.

Indications For Use:

USE ETCH-DETECT TO DE TECT RESIDVAL AROTEIN) WHILE ETCHIN. DECAY (DENATURED " TOTAL ETCH " TECHNIR DENTINE IN THE

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

Con(urrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96).

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ..

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.