The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.

The device can also be used to clean the following:

implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching
crowns and bridges
fixed bands and brackets prior to placement on orthodontic appliances.

Device Description

The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and AirFlow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the turbine tube and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called AirFlow handy, a dental handpiece. However, it does not contain acceptance criteria for device performance or a detailed study description that proves the device meets specific acceptance criteria.

The section titled "PERFORMANCE TESTING" briefly mentions that testing was performed to support a minimal reuse life and connection integrity, but it does not specify acceptance criteria (e.g., "device must withstand X cycles without failure") or detailed results against such criteria.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified	Reuse life: Supported a minimal reuse life of 130 treatments (corresponding to 15 hours of use).
Not specified	Connection integrity: The connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar.

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This document is a regulatory submission from a Swiss company (Electro Medical Systems SA, Nyon, Switzerland) to the US FDA, so the testing likely occurred as part of the product development and validation for market approval.

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

Number of Experts: Not applicable. The "performance testing" described is mechanical/durability testing, not related to expert evaluation of clinical performance or ground truth establishment in a diagnostic context.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable, as this was not a study involving human reader interpretation or adjudication of results.

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:

MRMC Study: No. This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool.
Effect Size: Not applicable.

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

Standalone Study: Not applicable. This is a non-AI mechanical device.

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

Type of Ground Truth: Not applicable in the context of expert consensus, pathology, or outcomes data as it relates to diagnostic performance. The "ground truth" for the performance testing cited would be the successful completion of the specified number of treatments and maintenance of connection integrity under pressure, as per engineering specifications.

8. The sample size for the training set:

Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that requires a training set.

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

Ground Truth for Training Set: Not applicable.

Summary

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7 1999 OCT

K991857

APPENDIX B

Modified 510(k) Summary

· .

9/9/99

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510(k) Summary for AirFlow handy

1. SPONSOR

Electro Medical Systems SA Ch. Vuarpillière 31 1260 Nyon SWITZERLAND

Contact Person: Daniel Rochat, Operational Director 41-22-994 47 18, 41-22-994 47 00 Telephone:

Date Prepared: September 9, 1999

2. DEVICE NAME

Proprietary Name: AirFlow handy Common/Usual Name: Dental handpiece Dental handpiece and accessories Classification Name:

3. PREDICATE DEVICES

AirFlow SII (K900709) .
. Prophyflex 2, Model 2012 (K973876)

4. DEVICE DESCRIPTION

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5. INTENDED USE

The device can also be used to clean the following:

implant abutments and teeth prior to treatments such as shade matching, . fluoridation, and bleaching
crowns and bridges .
fixed bands and brackets prior to placement on orthodontic appliances. .

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Both the proposed device and the substantially equivalent devices are intended for use in the cleaning and polishing of teeth. Unlike the predicate AirFlow SII, the proposed device does not function as a scaler.

The operational principle of the proposed device is identical to that of the AirFlow SII and the Prophyflex 2. The cleaning and polishing action is produced by the projection of air, water, and bicarbonate powder onto the tooth surface. The proposed device is supplied with a fixed nozzle or a rotating nozzle with a tip angle of 90° or 120°. The fixed AirFlow nozzle is identical to the nozzle used for the predicate AirFlow SII. The rotating AirFlow nozzles are identical to the predicate AirFlow SII except for minor design modifications to permit the tip to rotate. The rotating nozzle is also similar to the Prophyflex II nozzle.

The AirFlow handy differs from the AirFlow SII in size and in the location of the powder chamber. The proposed AirFlow handy is smaller than the AirFlow SII, and, like the Prophyflex 2, the powder chamber has been incorporated into the body of the device.

The differences between the proposed and predicate devices are restricted to minor differences in size, design, and materials and do not impact the safety or effectiveness of the device.

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7. PERFORMANCE TESTING

Testing was performed to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. Connection-integrity testing demonstrated that the connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar.

9/9/99

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing health, family, and community.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1999

Cynthia J.M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K991857 AirFlow Handy Trade Name: Requlatory Class: ने Product Code: EFB 1999 Dated: September 9, Received: September 10, 1999

Dear Dr. Nolte:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially 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, qood 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Dr. Nolte

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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510(k) Number: K991857

Device Name: AirFlow handy

Indications for Use:

The device can also be used to clean the following:

implant abutments and teeth prior to treatments such as shade matching, . fluoridation, and bleaching
crowns and bridges
fixed bands and brackets prior to placement on orthodontic appliances.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

usem (Division Sign-Off) Divis on of Dental, Infection Control, Divis of of Dental, Infostion
and General Hospital Device 510(k) Number -

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.