Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.

AI/ML Overview

The provided text is a 510(k) summary for the Lotus Prophy Angle, a Class I medical device (dental handpiece and accessories). This type of device is a physical tool and does not involve AI, software, or algorithms that would require the creation of a ground truth, training data, or a test set as described in your request. The acceptance criteria and performance studies are focused on physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, many of the requested fields are not applicable to this type of device. I will address the applicable parts of your request based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria (from ANSI/ADA Specification No. 85-1 for Disposable Prophy Angles) | Reported Device Performance |
|------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Speed | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Load | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Temperature Rise | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Vibration Analysis | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |

Study Details (as per document):

The document states: "The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis."

This implies that instead of full, new performance studies demonstrating quantitative measurements, the primary "proof" of meeting acceptance criteria relies on substantial equivalence to a predicate device (ProAngle™ Disposable Prophy Angle, K030603) and confirmatory testing to verify this equivalence.

Based on the provided document, the following points are largely N/A (Not Applicable) or cannot be determined for the reasons explained:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. This device is a physical dental instrument, not an AI/software device that uses data for a "test set" in the context of diagnostic performance. The "testing" mentioned refers to physical performance characteristics. The document does not specify sample sizes for these physical tests or data provenance beyond stating compliance with a standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This concept is not applicable to a physical dental prophy angle. There is no diagnostic "ground truth" to establish by experts for this type of device.

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

N/A. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.

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

N/A. This is a physical device, not an AI system. MRMC studies are not applicable.

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

N/A. This is a physical device, not an algorithm.

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

N/A. As mentioned, "ground truth" as it pertains to diagnostic accuracy is not relevant for a physical dental instrument. The "truth" here is compliance with engineering standard specifications.

8. The sample size for the training set

N/A. There is no "training set" for a physical device in the AI/machine learning sense.

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

N/A. See point 8.

Summary

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November 7, 2022

AJK Engineering, Inc. % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K220346

Trade/Device Name: Lotus Prophy Angle Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: August 12, 2022 Received: August16, 2022

Dear Christine Scifert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220346

Device Name Lotus Prophy Angle

Indications for Use (Describe)

The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

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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510(k) Summary Lotus Prophy Angle August 12, 2022

Company:	AJK Engineering, Inc.1605 Ashley CourtSommerville, SC 29486Phone: 888-962-1652
Company Contact:	Ajay Kumarajay@lotus-dpa.com
Official Correspondent:	Christine Scifert – MRC Global, LLCChristine.scifert@askmrcglobal.com901-831-8053
Trade Name:	Lotus Prophy Angle
Common Name:	Handpiece, Contra- And Right-Angle Attachment, Dental
Classification:	Class I
Regulation Number:	21 CFR 872.4200
Panel:	Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Division of Dental and ENT Devices
Product Code:	EGS

Device Description:

Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.

Indications for Use:

The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

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Substantial Equivalence:

The subject device is substantially equivalent to the following predicate device:

Primary Predicate:

Pac-Dent International (Suzhou), Inc., ProAngle™ Disposable Prophy Angle, K030603

Characteristic	Lotus Prophy Angle	Primary Predicate:Pac-Dent International (Suzhou), IncProAngle™ Disposable Prophy Angle
510(k) Number	SUBJECT	K030603
Intended Use	Disposable Prophy Angle	Disposable Prophy Angle
Product Code	EGS	EGS
Indications forUse	The intended use of the Lotus Prophy Angle isfor polishing and cleaning teeth.	The intended use of the ProAngle™ disposableprophy angle is for polishing and cleaningteeth.
Materials	Housing: Polycarbonate (PC)	Housing: Polycarbonate (PC)
	Gears: Polyoxymethylene (POM)	Gears: Polyoxymethylene (POM)
	Splatter guard: Silicone	Splatter guard: Silicone
	Cups: Thermoplastic Elastomer (TPE)	Cups: Thermoplastic Elastomer (TPE)
	Inserts: Polycarbonate (PC)	Inserts: Polycarbonate (PC)
Sterility	Non-Sterile	Non-Sterile

The subject and predicate devices are identical in Intended Use, Technological Characteristics, Performance Specifications, and Material. Therefore, it can be concluded that the subject Lotus Prophy Angle does not raise new questions of safety and effectiveness when compared to the predicate devices.

Performance Testing:

The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis.

Conclusion:

Since the subject and predicate device are identical in every way, the subject device is determined to be substantially equivalent to the predicate device.

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.