The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.

AI/ML Overview

The provided text describes a 510(k) summary for the EMS AIR-FLOW MASTER device. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods in the manner typically expected for a detailed study report.

The text primarily focuses on:

Device description and intended use: Detailing what the device is and what it's used for (non-surgical removal of subgingival plaque in pockets up to 5mm).
Technological characteristics and substantial equivalence: Comparing the new device to a predicate device and explaining why it is substantially equivalent.
Testing performed: Stating that electrical safety, electromagnetic compatibility, performance testing, and clinical data were provided.

Therefore, I cannot fulfill all aspects of your request as the specific information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not Specified	"Test results demonstrate that the EMS AIR-FLOW MASTER fulfills the prospectively defined performance specifications and can be used safely and effectively for subgingival cleaning."

Specific numerical acceptance criteria (e.g., minimum plaque removal percentage, maximum adverse event rate) and detailed performance metrics are not provided.

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

Sample size for test set: Not specified. The document only mentions "clinical data" was provided.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set:

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 MRMC study is mentioned. This device is an air-polishing unit, not an AI diagnostic tool that requires human readers.

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

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

7. The type of ground truth used:

For a device like this, ground truth would typically refer to the clinical assessment of plaque removal and pocket depth reduction by a dental professional. However, the exact methodology for establishing this "ground truth" in the clinical data is not detailed.

8. The sample size for the training set:

Not applicable/Not specified. This is a physical device, and the concept of a "training set" as used in AI/machine learning does not apply in this context unless referring to product development and testing cycles, which are not detailed here.

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

Not applicable/Not specified for the reasons above.

In summary: The provided document is a 510(k) summary, which is a regulatory filing. While it states that performance testing and clinical data were provided, it does not offer the granular detail regarding study design, acceptance criteria, sample sizes, or ground truth establishment that you are requesting. Such details would typically be found in the full study report, not in this summary document.

Summary

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FEB 1 8 2009

510(k) Summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA EMS AIR-FLOW MASTER

1. SPONSOR

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E.M.S. ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Contact Person: Suzanne Fassio-Hardy 022 994 47 00 Telephone:

Date Prepared: February 5, 2009

2. DEVICE NAME

Proprietary Name:	EMS AIR-FLOW MASTER
Common/Usual Name:	Airbrush/Dental handpiece
Classification Name:	Airbrush and accessories/Dental handpiece and accessories

3. PREDICATE DEVICES

Electro Medical Systems S.A., AIR-FLOW MASTER STANDARD (K073284) o

4. INTENDED USE

The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.

The EMS AIR-FLOW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

DEVICE DESCRIPTION 5.

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CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed EMS AIR-FLOW MASTER is similar in design and materials to the predicate EMS AIR-FLOW MASTER STANDARD. The proposed device is supplied with a flexible thermoplastic nozzle that allows the device to be used for subgingival cleaning of periodontal pockets.

Both the proposed EMS AIR-FLOW MASTER and predicate EMS AIR-FLOW MASTER STANDARD are intended for the cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. However, the proposed AIR-FLOW MASTER is supplied with a flexible, thermoplastic nozzle, which allows the indications for the device to be extended to include subgingival cleaning of periodontal pockets.

Both the proposed EMS AIR-FLOW MASTER and the predicate EMS AIR-FLOW MASTER STANDARD dental air-polishing unit consist of an operating unit, air pressure powered handpiece cords, powder chambers, handpieces, prophylaxis powder, multifunction footpedal and connections for external water and air supply. The AIR-FLOW MASTER PERIO-FLOW handpiece is specially designed for subgingival cleaning of periodontal pockets.

Testing provided in this premarket notification includes electrical safety, electromagnetic compatibility, performance testing and clinical data. Test results demonstrate that the EMS AIR-FLOW MASTER fulfills the prospectively defined performance specifications and can be used safely and effectively for subgingival cleaning. The similarities in intended use, operational characteristics, and functional technological characteristics between the AIR-FLOW MASTER and the AIR-FLOW MASTER STANDARD lead to a conclusion of substantial equivalence between the proposed and predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

E.M.S Electro Medical Systems S.A. C/o Dr. Cynthia J. M. Nolte Senior Regulatory Affairs Consultant Medical Device Consultants. Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

FEB 1 8 2009

K082791 Trade/Device Name: EMS AIR-FLOW MASTER Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: EFB Dated: February 5, 2009 Received: February 6, 2009

1991 - 1994 -

Dear Dr. Nolte:

" Re:

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 -Dr. Nolte

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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anthony V. Marchese, M.D.

Ginette Y. Michaud, M Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K082791

Device Name:

EMS AIR-FLOW MASTER

Indications for Use:

The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.

The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Prescription Use X (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 Ruane

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081729

Electro Medical Systems, Air-Flow Master Additional Information - K082791

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.