The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.

Device Description

The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator. The Expasyl Power Applicator is connected to any micro-motor (air or electric) that has a coupling socket and a maximum speed of 40,000 rpm. When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped. The capsule holder of the Expasyl Power Applicator is autoclaveable.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for a dental device, the Expasyl Power Applicator. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study report proving specific performance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for device performance cannot be extracted from this document.

The document primarily focuses on establishing that the Expasyl Power Applicator is substantially equivalent to the predicate device, Electro Medical Systems, EMS Air-Flow handy 2, for its intended use of dispensing a hemostatic/gingival retracting agent. Substantial equivalence in this context means the device performs in a similar manner and is intended for a similar use, rather than meeting specific quantitative performance metrics like a diagnostic AI model.

Here's what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated with quantifiable measures. The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This is a regulatory standard, not a performance metric like sensitivity or specificity.
Reported Device Performance: Not reported in terms of quantitative performance metrics (e.g., accuracy, precision). The document describes the device's function: "The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator." It also mentions "When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped." These are functional descriptions, not performance results from a study against specific acceptance criteria.

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

Not applicable. This document does not describe a performance study with a test set of data samples.

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

Not applicable. There is no performance study described with a ground truth established by experts.

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

Not applicable. There is no performance study described requiring adjudication.

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 dental handpiece for dispensing paste, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is a mechanical device, not an algorithm.

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

Not applicable. There is no performance study where ground truth was established.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm or training set.

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

Not applicable. There is no machine learning algorithm or training set.

In summary: The provided text is a 510(k) premarket notification for a dental handpiece, seeking substantial equivalence to a predicate device. It does not contain information about acceptance criteria, performance studies, test sets, ground truth establishment, or human-in-the-loop assessments as would be relevant for, for instance, an AI-powered diagnostic device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Sybron Dental Specialties, along with the date JAN 3 2006. To the right of the logo is the code K 051933. The logo is a stylized "sds" with a swoosh above it. The text "SYBRON DENTAL SPECIALTIES" is below the logo.

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: July 2005

Device Name:

Trade Name Expasyl Power Applicator .
Common Name Dental Handpiece .
Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 .
Devices for Which Substantial Equivalence is Claimed:
. Electro Medical Systems, EMS Air-Flow handy 2

Device Description:

Intended Use of the Device:

The intended use of the Expasyl Power Applicator is to dispense Expasyl, a temporary hemostatic/gingival retracting agent.

Substantial Equivalence:

The Expasyl Power Applicator is substantially equivalent to other legally marketed devices in the United States. The Expasyl Power Applicator functions in a manner similar to and is intended for a similar use as the product Air-Flow handy 2 cleared for marketing for Electro Medical Systems.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 3

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re: K051933

Trade/Device Name: Expasyl Power Applicator Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 14, 2005 Received: December 15, 2005

Dear Ms. Boswell:

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.

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Page 2 - Ms. Boswell

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 (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.

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 (240) 276-0115. 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 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/industry/support/index.html.

Sincerely yours,

Clus

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number (if known):

Device Name: Expasyl Power Applicator

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number	K051933

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Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).