The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

Device Description

Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premium Plus Prophy Air Motor. Based on the document, this is a Class I medical device (dental handpiece and accessories). For Class I devices, the level of regulatory scrutiny and required evidence of "performance" to establish substantial equivalence is generally much lower than for Class II or Class III devices, especially those involving AI/ML.

The provided document describes a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove efficacy or performance in the same way an AI/ML device would be scrutinized. Therefore, the "acceptance criteria" here relate to meeting basic safety and performance standards for a simple mechanical device and demonstrating similarity to an existing device. The "study" refers to the engineering and biocompatibility tests conducted.

Most of the specific information requested in your prompt (e.g., sample size for test set regarding AI algorithms, number of experts for ground truth, MRMC studies, standalone AI performance) is not applicable or not present in this type of submission for a simple mechanical dental device. This FDA submission is not for an AI/ML device.

Here's the closest breakdown based on the provided text:

Acceptance Criteria and Device Performance for Premium Plus Prophy Air Motor (K170261)

The Premium Plus Prophy Air Motor is a Class I mechanical dental device. The "acceptance criteria" in this context are defined by compliance with recognized international standards for dental handpieces and by demonstrating substantial equivalence to a predicate device. The "performance" refers to the device meeting the specifications outlined in these standards and its functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Indications for Use	"The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis." (Same as predicate)	Met (Stated as same as predicate device: Prophy Star 3 Hygiene Handpiece K070869)
Functional Performance & Safety	Compliance with ISO 14457:2012 (Dentistry Handpieces and Motors Test)	"The test results confirm that Premium Plus Prophy Air Motor conforms to the requirements in ISO 14457:2012..." This standard likely covers aspects like mechanical safety, operating characteristics, and durability. The device also claims "Robust construction to withstand forces generated during cleaning cycle." It passed a performance test in accordance with ISO 14457.
	Compliance with ISO 9168:2009 (Dentistry Hose Connectors for Air Driven Dental Handpieces Test)	"The test results confirm that Premium Plus Prophy Air Motor conforms to the requirements... ISO 9168:2009..." This standard ensures proper connection and compatibility with dental unit air hoses.
Biocompatibility	- Cytotoxicity per ISO 10993-5: 2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	"Biocompatibility tests were conducted in accordance with the requirements of ISO 10993-5..." and stated as "Made of non-toxic anodized aluminum." The document implies the tests were successfully passed, leading to the "Same" conclusion in the comparison table.
	- Oral Irritation per ISO 10993-10: (Biological evaluation of medical device - Part 10: Tests for irritation and delayed -type hypersensitivity)	Biocompatibility tests were conducted. Implied to have met criteria.
	- Sensitization per ISO 10993-10: (Biological evaluation of medical device - Part 10: Tests for irritation and delayed -type hypersensitivity)	Biocompatibility tests were conducted. Implied to have met criteria.
Reprocessing (Cleaning & Sterilization) Validation	Recommendations of FDA Guidance on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" followed. Specific tests:	"Validation Testings" were performed, including: Cleaning Validation Protein Analysis, Cleaning Validation - Hemoglobin Analysis, Sterilization Validation - Gravity cycle 132 ℃ 15min, Sterilization Validation - Gravity cycle 121 ℃ 30min, Sterilization Validation - Prevacuum cycle 132 ℃ 4min. The successful completion of these tests suggests validation criteria were met.
Device Characteristics (Comparison to Predicate)	- Operating Air Pressure: Close to predicate (Predicate: 35-40 psi; Subject: 200kPa ≈ 29 psi)	Met (Difference noted but considered substantially equivalent for a Class I device).
	- Operating Speed: Within reasonable range of predicate (Predicate: 0 to 5,000 rpm; Subject: 0 to 2,480 rpm)	Met (Difference noted, but "The subject device's operational speed is within the extent of the predicate device's speed." and deemed substantially equivalent).
	- Power Output: Close to predicate (Predicate: 5.8 Watts; Subject: 6.0 Watts)	Met (Very similar).
	- Design, Materials (e.g., anodized aluminum), Compatibility with standard connectors (Mid-West style air hose, Doriot style prophy angles), Sterility (Non-sterile)	All stated as "Same" or very similar to the predicate device, contributing to the claim of substantial equivalence. The slight differences in length/diameter/weight were noted but not considered to affect substantial equivalence for this device type.

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

Sample Size: Not explicitly stated for each test (e.g., "Performance Test," "Biocompatibility Test," "Validation Testings"). These typically involve testing a representative sample of devices, but specific numbers are not provided in this summary. For Class I mechanical devices, the number of units tested is generally small as standardized tests are conducted on representative samples to ensure manufacturing quality and design integrity.
Data Provenance: The device manufacturer, Premium Plus International Limited, is located in Hong Kong, China. The testing itself is conducted to international standards (ISO) and FDA guidance, but the exact location of the testing laboratories (e.g., in Hong Kong, or a third-party lab elsewhere) is not specified. The tests are prospective in the sense that they are performed on the device being submitted for marketing.

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

This concept is not applicable here. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where there is an interpretation or classification task. For a mechanical dental handpiece, the "ground truth" is determined by objective physical measurements and adherence to engineering standards.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, often for AI/ML devices or diagnostic tests. Here, the "tests" are compliance with engineering standards and validation protocols.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-driven ones, to assess how AI assistance impacts human reader performance. This device is a simple mechanical prophy air motor, not a diagnostic tool or an AI/ML product.

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

No, a standalone performance study in the context of an "algorithm" was not done. This device does not contain an algorithm or AI component. Its performance is measured directly through mechanical, airflow, and material safety tests.

7. The Type of Ground Truth Used

As this is a mechanical device, the "ground truth" is established by:

Compliance with objective engineering standards (e.g., ISO 14457, ISO 9168).
Results from biocompatibility assays (e.g., cytotoxicity, irritation, sensitization tests per ISO 10993 standards) where "ground truth" is defined by the test's positive/negative control and specific criteria for material response.
Results from reprocessing validation tests (e.g., protein/hemoglobin analysis, sterilization cycles) designed to demonstrate effective cleaning and sterilization.
Direct physical and operational measurements (e.g., dimensions, weight, air pressure, operating speed, power output) compared against specifications and the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable. This device is a mechanical product, not an AI/ML algorithm. There is no "training set" for an algorithm.

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

This concept is not applicable as there is no training set.

Summary

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Premium Plus International Limited Jessica Mao QA Engineer Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West Yuen Long, N.T. Hong Kong, China

Re: K170261

Trade/Device Name: Premium Plus Prophy Air Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: September 11, 2017 Received: September 15, 2017

Dear Jessica Mao:

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.

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 19, 2017

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K170261

Device Name Premium Plus Prophy Air Motor

Indications for Use (Describe)

The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com

Section 5 510(k) Summary

[As Required by 21 CFR 807.92]

Revision date: Oct. 17, 2017

Premium Plus International Limited Submitter: Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, N.T. Hong Kong, China (Establishment registration number: 3006847937)

Contact Person: Jessica Mao QA Engineer Tel: 852-27613211 Fax: 852-27613210 Email: jessicamao@premiumplushk.com

Trade/Device Name: Premium Plus Prophy Air Motor Common Name: Dental Handpiece Model Type: 1002-4 Device Panel: Dental Basis for Submission: New Device Regulation Name: Handpiece, Air-Powered, Dental Device Classification: Class I Regulation Number: 21 CFR 872.4200 Regulation Description: Dental Handpiece and Accessories Product Code: EFB

Predicate Device to Premium Plus Prophy Air Motor:

Trade Name: Prophy Star 3 Hygiene Handpiece 510(k) Number: K070869 Manufactured by: DentalEz Inc., StarDental Division

Device Description:

Indications for Use:

The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 1 of 4 Section 5

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Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG
Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com

	Predicate Device	Subject Device
Device	Prophy Star 3 HygieneHandpiece (K070869)	Premium Plus ProphyAir Motor	/
Indications forUse	The prophy handpiece is usedby trained dentalprofessionals to performdental prophylaxis	Premium Plus ProphyAir Motor is intended tobe used with adisposable prophy angleand polishing paste by atrained dental clinicianto perform dentalprophylaxis.	Same
Target Users	Professional dentists andhygienists	Professional dentistsand hygienists	Same
Location ofUse	Dental offices	Dental offices	Same
ProductDesign	Metal housing (externalcasing) with internal driveshaft, gearings and chuckassembled and aligned toeach other.	Anodized aluminumhousing with internaldrive shaft, gearingsand chuck assembledand aligned to eachother	Same
Dimensions &Weight:	Length 108.99 mmDiameter at handle 16.76 mmWeight 62 grams	Length 111.00 mmDiameter at handle 16.76 mmWeight 69 grams	Thesubjectdevice is a bitlonger, bigger,and heavier thanthe predicatedevice.
Operating AirPressure,OperatingSpeed andPower Output	Air Pressure 35-40 psiOperating Speed 0 to 5,000rpmPower Output 5.8 Watts	Air Pressure 200kPaOperating Speed 0 to2,480 rpmPower Output 6.0 Watts	Operating speedis different
DriveMechanism	Chuck driven by pneumaticair rotor	Chuck driven bypneumatic air rotor	Same
Bio-compatibility	Made of non-toxic anodizedaluminum	Biocompatibility testswere conducted inaccordance with therequirements of ISO10993-5 and ISO	Same
Compatibilitywith otherdental devices	Designed to fit securely ontostandard Mid-West style airhose connector and standardDoriot style prophy angles	Designed to fit securelyonto standard 4-hole(mid-west style)connector and standardDoriot style prophyangles	Same
Sterility	Non-sterile	Non-sterile	Same
MechanicalSafety	Robust construction towithstand forces generatedduring cleaning cycle	Robust construction towithstand forcesgenerated duringcleaning cycle. Thesubject device passedthe performance test inaccordance with ISO14457.	Same

Comparison of Technological Characteristics:

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Flat 1001 Yven Long Trading Centre, No. 33 Wang Yip Street West, Yven Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com

Discussion of similarities and differences between the Proposed Device and the Predicate Device

In compare to the Prophy Star 3 Hygiene Handpiece, the Premium Plus Prophy Air Motor has the same indications for use, same target users and same location of use. They both have the same drive mechanism. They both have similar dimensions & weight, similar operating air pressure and similar power output. Furthermore, they both are non-sterile, bio-compatible, compatible with the same type of air hose connector and same type of disposable prophy angle, and both are mechanically safe.

Their operational speeds are different. The subject device's operational speed is within the extent of the predicate device's speed. The subject device conforms to the requirements of ISO 14457.

Performance Test:

The following tests were conducted to evaluate the functional performance and safety of Premium Plus Prophy Air Motor:

ISO 14457:2012 Dentistry Handpieces and Motors Test ●
ISO 9168:2009 Dentistry Hose Connectors for Air Driven Dental Handpieces Test ●

The test results confirm that Premium Plus Prophy Air Motor conforms to the requirements in ISO 14457:2012 and ISO 9168:2009, and is substantially equivalent for use as a dental prophy air motor.

An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 3 of 4 Section 5

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Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com

Biocompatibility Test:

The following tests were performed to evaluate the biocompatibility of the device:

Cytotoxicity per ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: ● Tests for in vitro cytotoxicity
Oral Irritation per ISO 10993-10: Biological evaluation of medical device - Part 10: Tests for irritation and delayed -type hypersensitivity
Sensitization per ISO 10993-10: Biological evaluation of medical device Part 10: Tests ● for irritation and delayed -type hypersensitivity

Validation Testings:

Recommendations of the FDA Guidance on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed.

Cleaning Validation Protein Analysis ●
Cleaning Validation - Hemoglobin Analysis
Sterilization Validation - Gravity cycle 132 ℃ 15min
Sterilization Validation - Gravity cycle 121 ℃ 30min
Sterilization Validation - Prevacuum cycle 132 ℃ 4min

Conclusion

Based on the above analysis, Premium Plus International Limited believes that the Premium Plus Prophy Air Motor is Substantially Equivalent to the claimed predicate, that is the Prophy Star 3 Hygiene Handpiece.

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.