ULTRADENT CITRIC ACID 10% SOLUTION by ULTRADENT PRODUCTS, INC.

This is a 510(k) premarket notification letter from the FDA regarding a dental device called "Ultradent Citric Acid 10% Solution," which is a root canal cleanser. The letter primarily focuses on the FDA's determination of substantial equivalence to existing predicate devices, allowing it to be marketed.

However, a 510(k) summary for a device like a root canal cleanser, especially one classified as unclassified, does not typically include detailed clinical acceptance criteria or a study design as you've requested for AI/ML-based devices.

Here's why and what information can be extracted/inferred:

Nature of the Device: This is a chemical solution used in a dental procedure, not an imaging or diagnostic AI-powered device. Its "performance" is typically assessed through chemical properties, stability, and compatibility within the root canal environment, rather than metrics like sensitivity, specificity, or AUC as seen in AI studies.
Regulatory Pathway (510(k)): The 510(k) pathway is about demonstrating substantial equivalence to a legally marketed predicate device. This often relies on comparing technical characteristics, materials, intended use, and sometimes non-clinical performance data (e.g., pH, concentration, microbiology) rather than extensive human clinical trials with intricate ground truth panels and MRMC studies.
"Unclassified" Status: Since it's unclassified, it means there isn't a specific regulation number or class (Class I, II, or III) for this type of device, which further points away from the need for complex clinical efficacy studies typically required for higher-risk devices or novel technologies.

Therefore, I cannot provide the detailed information requested in your prompt because the provided document (an FDA clearance letter for a 510(k)) does not contain such a study or acceptance criteria in the context of AI/ML device performance.

However, I can extract the following relevant information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics like sensitivity/specificity. For a substantial equivalence claim, the acceptance criteria are typically met if the device has the "same intended use as the predicate device" and "same technological characteristics as the predicate device" or "different technological characteristics from the predicate device and the new characteristics do not raise new questions of safety and effectiveness, and the device is as safe and effective as the predicate device."

Reported Device Performance: The document states the device name is "Ultradent Citric Acid 10% Solution" and its intended use is "to etch the canal walls, especially ape [apex] to allow optimum seal." No specific numerical performance metrics are provided in this regulatory letter itself. The equivalence is established against a predicate device.

Acceptance Criterion (Inferred from 510(k) process)	Reported Device Performance (Inferred from 510(k) clearance)
Intended Use: Same as predicate device.	Ultradent Citric Acid 10% Solution is used just prior to obturation to etch the canal walls, especially ape [apex] to allow optimum seal. (Matches typical use of citric acid solutions in endodontics).
Technological Characteristics: Equivalent to predicate device (e.g., composition, concentration, pH).	Ultradent Citric Acid 10% Solution (implied to be 10% citric acid). Details not in this letter, but were submitted in the K032627 application.
Safety & Effectiveness: As safe and effective as predicate device.	Device found "substantially equivalent" to legally marketed predicate devices, implying safety and effectiveness.
Biocompatibility: (Common for devices in contact with tissue)	Not detailed in this letter, but likely assessed in the K032627 submission to be equivalent to predicate.
Sterility: (If applicable)	Not detailed in this letter, but likely assessed in the K032627 submission.

Regarding the other points you requested for AI/ML devices, this letter does not contain that information:

Sample size for the test set and data provenance: Not applicable/provided. This device is not an AI/ML product.
Number of experts used to establish the ground truth...: Not applicable/provided. Ground truth using expert clinicians for AI performance is not relevant here.
Adjudication method: Not applicable/provided.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable/provided.
Standalone (algorithm only without human-in-the loop performance) study: Not applicable/provided.
Type of ground truth used: For a chemical solution, "ground truth" would relate to its chemical properties, stability, and efficacy in dissolving/etching, assessed via laboratory or non-clinical studies. This letter does not detail those.
Sample size for the training set: Not applicable/provided (no AI training set).
How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided document is an FDA 510(k) clearance letter for a non-AI dental solution, not a clinical study report for an AI/ML-based device. Therefore, the specific details you requested regarding clinical acceptance criteria and AI study methodologies are not present.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Mr. Peter Allred R&D Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

Re: K032627

Trade/Device Name: Ultradent Citric Acid 10% Solution Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: August 22, 2003 Received: September 09, 2003

Dear Mr. Allred:

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.

{1}------------------------------------------------

Page 2 - Mr. Peter Allred

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 (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.

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), please contact the Office of Compliance at (301) 594-4613. 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) you may obtain. 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 vours.

Ques

Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

(14032627 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Ultradent Citric Acid 10% Solution is used just prior to obtigation to etch the canal walls, especially ape to allow optimum seal.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2

Susan Rupp

Infection Control, D

510(k) Number: K030227

Page

Regulation Number and Section

N/A