The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "

Device Description

The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.

AI/ML Overview

The provided text describes a 510(k) submission for a dental device, the "Bosworth Air Polisher." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific performance metrics and acceptance criteria in the same way a novel device might.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission in the provided document. The "study" here is primarily a comparison to a predicate device and limited performance testing to support basic functionality.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for a 510(k) are typically based on demonstrating equivalent performance or safety to a predicate device, as opposed to establishing specific numerical thresholds for clinical outcomes. The "performance" described here relates to functional tests rather than clinical efficacy.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Intended Use Equivalence	Device is intended for "cleaning & polishing of teeth by the projection of water, air, & dental powder onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth."	Met: The Bosworth Air Polisher has the identical intended use: "a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface." The Predicate Device is also an "Air Polisher."
Technological Equivalence	Device shares similar operating principle, function, cleaning/preparatory action, delivery control, activation, water/air supply, sterilization process with the predicate device.	Met: Both the Bosworth Air Polisher and the predicate device (EMS Air-Flow Master Standard) have an "identical operating principle: Projection of a powder, water, and air spray stream onto the tooth-surface-provides-the-cleaning-and-polishing-action." Detailed comparison in "Comparison Chart for Determination of Substantial Equivalence" shows high similarity.
Durability/Reuse Life	Support a minimal reuse life (e.g., specific number of treatments or hours of use).	Met: "The Bosworth Air Polisher was tested to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use."
Connection Integrity	Demonstrate that the turbine tube connection remains intact when subjected to specified air pressures.	Met: "The Turbine tube connection was tested for integrity to demonstrate that the connection between the Bosworth Air Polisher and the turbine adapter, when subjected to air pressures of 47 - 53 psi, remained intact."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in terms of human subjects or teeth. The tests described are functional engineering tests.
Data Provenance: The tests were conducted internally by the manufacturer, Harry J. Bosworth Company. The document does not specify country of origin for any "data" beyond the company's location in Skokie, Illinois, USA. The testing is retrospective to the submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. The "ground truth" for the tests described are engineering specifications and functional outcomes (e.g., connection remaining intact, completing 130 treatments). These are not clinical outcomes requiring expert adjudication in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

Not Applicable. As the tests are functional/engineering in nature, formal adjudication by multiple experts for a "test set" is not relevant or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed or described. This type of study is typically conducted for diagnostic devices or AI-assisted interpretation, which is not the nature of this dental hand-held device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is a mechanical dental handpiece, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this device. The device is the "algorithm" in that its mechanical function is its performance.

7. The Type of Ground Truth Used

Engineering Specifications and Functional Outcomes: The "ground truth" for the performance testing cited (reuse life, connection integrity) refers to successful completion of engineered stress tests against predefined functional criteria.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and performance are based on mechanical engineering principles, comparison to a predicate, and specified functional tests.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, there is no ground truth established for one. The "ground truth" for the device's design is the established performance and safety record of the predicate device and relevant engineering standards.

Summary

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Attachment B

K100731

510(k) Summary for

Bosworth-Air-Polisher_

Sponsor

Harry J. Bosworth Company 7227 N. Hamlin Avenue Skokie, Illinois 60076-0399 USA

DEC - 3 2010

Establishment # 1410638

Contact Person: Gary Chuven Telephone: 1-847-679-3400 ext. 240

Date Prepared: 10 November 2010

Device Name

Proprietary Name: Common/Usual Name: Classification name: Regulation: Product code:

Bosworth Air Polisher Dental handpiece Dental handpiece and accessories 21 CFR 872.4200 EFB

Device Description

Intended Use

This device is a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface.

Technological Characteristics and Substantial Equivalence

The Bosworth Air Polisher and the predicate device AirFlow Master Standard (Electro Medical Systems K073284) are used for cleaning and polishing of teeth.

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Both the Bosworth Air Polisher and the predicate device have an identical operating principle. Projection of a powder, water, and air spray stream onto the tooth-surface-provides-the-cleaning-and-polishing-action______________________________________________________________________________________________________________________

Comparison Item	Bosworth Prophy Gun -Proposed	EMS Air-Flow MasterStandard - K073284
Intended Use	Cleaning & polishing of teeth by the projection of water, air, & dental powder onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.	Air Polisher
Function	Air Polisher	Air Polisher
Cleaning &Preparatory Action	Projection of air/water/powder mixture.	Projection of air/water/powder mixture.
Delivery Control	Dental operatory unit	Dedicated operational unit
Foot pedal Activation	Yes	Same
Water & Air Supply	External	Same
Powder Location	Powder chamber on the handpiece	Powder chamber on the operational unit
Prophy Powder	Bosworth Prophy Powder	Air-Flow Classic
Sterilization Process	Handpiece & powder nozzle: steam	Handpiece & powder nozzle: steam

Comparison Chart for Determination of Substantial Equivalence

Performance Testing

The Bosworth Air Polisher was tested to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. The Turbine tube connection was tested for integrity to demonstrate that the connection between the Bosworth Air Polisher and the turbine adapter, when subjected to air pressures of 47 - 53 psi, remained intact.

Conclusion Statement

Based on the comparison between the Bosworth Air Polisher and the predicate device AirFlow Master Standard, the clinical information, and on the specific testing performed on the Bosworth Air Polisher, we conclude that the Bosworth Air Polisher is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Gary Chuven Quality & Regulatory Manager Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

Re: K100731

Trade/Device Name: Bosworth Air Polisher Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: November 15, 2010 Received: November 17, 2010

DEC - 3 2010

Dear Mr. Chuven:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Chuven

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(K) Number: K100731

Device Name: Bosworth Air Polisher

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-the-Counter Use
Su(Optional Format 1/2/96)

(Division Sign-Off) (Division Sign-Oit)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ansothol. Dental Devices

510(k) Number:

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.