The EMS AIR-FLOW® handy 2 is intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching. fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

Device Description

The AIR-FLOW® handy 2 is a modified version of the AirFlow® handy previously cleared under K991857. As with the original AirFlow® handy device, the proposed AIR-FLOW® handy 2 is a turbine-adaptable air polisher that consists of a hand-held device containing air and water lines, powder chamber with cap, and an AIR-FLOW® nozzle called the AIR-FLOW® handpiece.

Both the original and the modified device function by connecting to a standard turbine connection of the dental unit, which supplies air and water. The AIR-FLOW® handy 2 is activated when the AIR-FLOW® handy 2 Handpiece is fixed to the turbine connection and the dental unit pedal is pressed. Air enters the proximal end of the device and into the powder chamber where it is mixed with the AIR-FLOW® handy 2 powder. The air/powder mixture leaves the powder chamber and exits the distal end of the device through the AIR-FLOW® handpiece orifice where the air/powder mixture is enveloped by a water spray and directed onto the tooth surface.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (EMS AIR-FLOW® handy 2 Dental Handpiece). It details the device's intended use, description, and basis for substantial equivalence to a predicate device. However, it does not contain the detailed study information typically required to describe acceptance criteria and the methods used to prove the device meets them in the way modern AI/ML device submissions would.

Specifically, the document states:

"Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met. The final project monitoring results documented that all verification and validation activities required by the risk analysis were performed and all requirements of the design specifications were met."

This is a general statement about fulfilling design requirements and risk analysis, but it does not include:

Specific acceptance criteria: What quantitative or qualitative metrics were used to determine "design requirements were met"?
Reported device performance: What were the actual outcomes against those criteria?
Details about the study: No information on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating where information is NOT available:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the EMS AIR-FLOW® handy 2 Dental Handpiece states that "Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met." However, it does not detail specific acceptance criteria or the reported performance data against those criteria in a tabular format as would typically be presented for performance studies. The submission focuses on demonstrating substantial equivalence to a predicate device (AirFlow® handy, K991857) through design modifications and function rather than an efficacy study with defined endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (as implied or if provided)	Reported Device Performance
No specific quantitative or qualitative acceptance criteria are provided in the document. The general statement is that "all design requirements were met."	No specific performance metrics are reported in the document. The implication is that the device functions as intended and meets its design specifications.
Implied Criteria (based on device description):
- Ability to project a mixture of water, air, and bicarbonate powder onto the tooth surface.	- The device functions by connecting to a dental unit and delivering an air/powder/water mixture to the tooth surface. (Functionality is described as achieved).
- Removal of soft deposits and discoloration.	- Intended use claims this capability. No specific performance data provided on efficacy of removal.
- Facilitated cleaning (due to straight tubing).	- Improved feature: straight tubing "reduces the probability of clogging and facilitates cleaning." (Claim made, no quantitative data).
- Reduced clogging (due to straight tubing and filters).	- Improved feature: straight tubing "reduces the probability of clogging." Filters "protect... by preventing any passage of impurities... and dissipates humidity... which prevents clogging." (Claim made, no quantitative data).
- Improved handling (due to longer handpiece).	- Improved feature: "handpiece is longer, facilitating handling and rotation of the handpiece by the user." (Claim made, no quantitative data).
- Increased powder chamber capacity (23g vs 18g).	- Feature implemented: "powder chamber capacity has been increased to 23 g from 18 g reducing the number of refills necessary during treatments." (Design specification, not a performance metric in terms of clinical outcome validation).

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

Sample Size: Not specified. The document states "Verification and validation of the device design requirements were performed," but provides no details on any test subjects, cases, or the number of items tested.
Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective)

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

Not applicable/Not specified. The document does not describe a clinical study that would require expert-established ground truth. The "testing" referred to appears to be engineering design verification and validation.

4. Adjudication method for the test set

Not applicable/Not specified.

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

No. This device is a dental handpiece, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable.

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

Not applicable. This device is a physical dental tool, not an algorithm.

7. The type of ground truth used

Not applicable. For a physical device like this, "ground truth" would typically refer to engineering specifications and performance against those specifications (e.g., air pressure, water flow, powder delivery rate, material strength, safety standards). The document generally states "all design requirements were met" but doesn't elaborate on the specific "ground truth" used or how it was established for performance aspects.

8. The sample size for the training set

Not applicable. This device is a dental handpiece, not an AI/ML model that requires a training set.

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

Not applicable.

Summary

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KOJJ119

JUL 2 5 2002

510(k) Summary for Electro Medical Systems SA AIR-FLOW® handy 2 Dental Handpiece

SPONSOR 1.

ELECTRO MEDICAL SYSTEMS SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland

Contact Person: Suzanne Fassio-Hardy Date Prepared: June 28, 2002

2. DEVICE NAME

Trade/Proprietary Name:	EMS AIR-FLOW® handy 2
Common/Usual Name:	Dental handpiece
Classification Name:	Dental handpiece and accessories

3. INTENDED USE

4. DEVICE DESCRIPTION

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device containing air and water lines, powder chamber with cap, and an AIR-FLOW® nozzle called the AIR-FLOW® handpiece.

న. BASIS FOR SUBSTANTIAL EQUIVALENCE

The AIR-FLOW® handy 2 has the same intended use as the original AirFlow® handy, which was determined to be substantially equivalent to marketed devices under 510(k) K991857.

The AIR-FLOW® handy 2 utilizes the same technique as the original AirFlow® handy. The AIR-FLOW® handy 2 offers several improved features including the following:

the air and powder tubing inside the handpiece is straight instead of curved, . which reduces the probability of clogging and facilitates cleaning
the handpiece is longer, facilitating handling and rotation of the handpiece by . the user during the treatment
. a filter and sieve have been added to the air and water lines offering protection of the one-way valve of the connector and the powder chamber. The filters and sieves protect the powder chamber and the one-way valves by preventing any passage of impurities that circulate in the water and air canals. The filter in the air canal prevents back-flow of powder and dissipates humidity by vaporization of any drops of water, which prevents clogging
the powder chamber capacity has been increased to 23 g from 18 g reducing . the number of refills necessary during treatments

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6. TESTING

Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met. The final project monitoring results documented that all verification and validation activities required by the risk analysis were performed and all requirements of the design specifications were met.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUL 2 5 2002

Electro Medical Systems SA C/O Ms. Mary McNamara-Cullinane Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K022119

Trade/Device Name: EMS Air-Flow Handy 2 Dental Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 28, 2002 Received: July 1, 2002

Dear Ms. Cullinane:

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.

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.

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Page 2 - Ms. Cullinane

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours,

Timothy A. Ulatowski

Tim Ulatowski Directo 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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510(k) Number (if known):

Device Name: AIR-FLOW® hạndy 2 Dental Handpiece

Indications For Use:

The EMS AIR-FLOW® handy 2 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Electro Medical Systems SA Special 510(k) AIR-FLOW® handy 2

June 28, 2002

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.