Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair.
The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread.
GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.

AI/ML Overview

The provided text is a 510(k) summary for "Ultrasonic Scaler Tips" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with a defined test set, ground truth experts, and statistical outcomes.

The document discusses:

Device Description and Intended Use: The device is an accessory for professional dental use to remove calculus and stain, and to clean/irrigate root canals.
Comparison to Predicate Devices: It details similarities and differences in product code, regulation, intended use, device description, operating principle, tip shapes, composition, coatings, interaction with other products, sterilization, and mechanism of treatment to establish substantial equivalence.
Performance Data: It lists bench performance testing (biocompatibility, reprocessing validation, conformity to ISO standards like ISO 18397 and ISO 3630-5) conducted to support substantial equivalence.
Absence of Clinical Data: Critically, it explicitly states, "The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence."

Therefore, the information required to answer your detailed questions about acceptance criteria, test set, data provenance, number/qualifications of experts, adjudication, MRMC studies, standalone performance, and ground truth for training/test sets is not available in this document. This document describes a 510(k) pathway, which often relies heavily on bench testing and comparison to legally marketed predicate devices rather than novel clinical performance studies, especially for devices like scaler tips.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific numerical acceptance criteria or clinical performance metrics for the device itself (e.g., how effectively it removes calculus). Instead, it states that tests were conducted to demonstrate conformity to applicable clauses of ISO standards and that biocompatibility and reprocessing validation were performed. The "performance" is implicitly deemed acceptable if it meets these bench test standards and allows for substantial equivalence to predicates.

Acceptance Criteria Category	Reported Device Performance (as stated or implied)
Biocompatibility	Conducted in accordance with FDA Guidance (ISO 10993-1); included cytotoxicity, skin sensitization, irritation, acute systemic toxicity, material-mediated pyrogens tests. (Implicitly passed, as substantial equivalence was determined)
Reprocessing Validation	Sterilization validated to ISO 17665-1:2006. Cleaning validation to AAMI TIR30, AAMI TIR12, and FDA guidance. (Implicitly passed)
Bench Performance	Conformity demonstrated to applicable clauses of: - ISO 18397 Dentistry Powered scaler - ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments (Implicitly passed)
Clinical Performance	Not Applicable / Not Required. "did not require clinical studies to support substantial equivalence."

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

Sample Size: Not specified for any "test set" in the context of clinical performance data, as clinical studies were not required. For bench testing (biocompatibility, reprocessing, ISO conformity), sample sizes would be determined by the specific test protocols and standards, but are not detailed here.
Data Provenance: Not specified, as clinical data was not used. The document pertains to a Chinese manufacturer (Guilin Refine Medical Instrument Co., Ltd.) seeking FDA clearance in the US, so any bench testing would likely have been conducted by or for the manufacturer.

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)

Not applicable. No clinical test set requiring expert ground truth was performed or required for this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was performed or required.

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

Not applicable. This device is an ultrasonic scaler tip, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned or relevant to its function.

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

Not applicable. This device is an ultrasonic scaler tip, not an algorithm.

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

Not applicable. No clinical ground truth was established or used, as no clinical studies were performed. Ground truth for the bench tests would refer to the validated methods and accepted reference standards of the specific physical, chemical, and mechanical tests conducted.

8. The sample size for the training set

Not applicable. No training set for an algorithm was used or mentioned.

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

Not applicable. No training set for an algorithm was used or mentioned.

In summary: The provided document is a 510(k) clearance letter and summary for an ultrasonic scaler tip, which falls under Class II medical devices. For such devices, particularly accessories, the FDA often relies on bench testing and substantial equivalence to existing predicate devices rather than requiring extensive clinical trials or AI-specific performance studies. The questions you've asked are highly relevant for AI/software as a medical device (SaMD) clearances, but not for this specific type of physical device and its associated 510(k) pathway.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2023

Guilin Refine Medical Instrument Co., Ltd. % Alice Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 CHINA

Re: K230641

Trade/Device Name: Ultrasonic Scaler Tips Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: August 28, 2023 Received: August 28, 2023

Dear Alice Yang:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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) K230641

Device Name

Ultrasonic Scaler Tips

Indications for Use (Describe)

The ultrasonic scaler tips are intended for use by dental professionals to:
1. Remove supra and sub gingival calculus deposits and stain from the teeth;
1. Clean and irrigate root canals.

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 K230641

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: November 20, 2023

Submission sponsor 1.

Name: Guilin Refine Medical Instrument Co., Ltd.

Address: No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, GuangXi, China 541004

Contact person: Chen Judong

Title: Management Representative

E-mail: chenjudong@refine-med.com

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Alice Yang

E-mail: yangjie@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Ultrasonic Scaler Tips
Model	GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1
Regulatory Class	Class II
Classification	21 CFR 872.4850 / Ultrasonic scaler / ELC
Submission type	Traditional 510(K)

3. Subiect Device Information

4. Predicate Device

1. Sapphire Plus@ Tips, San Diego Swiss Machining, K960889 (Primary)
1. tün® ultrasonic tips product family, Engineered Endodontics., K182145 (Reference)

Symmetry S-Series Piezoelectric Scaling Tips, Hu-Friedy Manufacturing Company, Incorporated, 3. K053178 (Reference).

5. Device Description

The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are

Section 5_510(k) Summary

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made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will beavailable in M3x0.6 internal thread .

GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.

Intended use & Indication for use 6.

The ultrasonic scaler tips are intended for use by dental professionals to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
1. Clean and irrigate root canals.

Features	Proposed deviceUltrasonicScaler Tip	PrimaryPredicatedevice K960889SapphirePlus@ Tips	ReferencePredicatedeviceK053178Symmetry S-SeriesPiezoelectricScaling Tips	ReferencePredicate deviceK182145tün® ultrasonictips ProductFamily	comment
Product code	ELC	ELC	ELC	ELC	Same
Regulationnumber	21 CFR 872.4850	21 CFR872.4850	21 CFR872.4850	21 CFR872.4850	Same
RegulationClass	Class II	Class II	Class II	Class II	Same
RegulationDescription	Scaler, Ultrasonic	Scaler,Ultrasonic	Scaler,Ultrasonic	Scaler,Ultrasonic	Same
Intended Use	The ultrasonicscaler tips areintended for useby dentalprofessionals to:1. Remove supraand sub gingivalcalculus depositsand stain from theteeth;	Reconstructivedental tissueduring endo rootprocedures,crown prep,canal prep.Remove perioprep, root prep	To be used byDentalProfessionalsduring dentalcleaning andperiodontal(gum)therapy toremovecalculus,plaque andstaining of theteeth by	tün® ultrasonictips are intendedfor use by dentalprofessionals forthe removal ofsoft and hardtissue duringendodontic rootcanal preparationprocedures. Theycan also aid inthe removal ofendodontic posts	SE
Features	Proposed device	PrimaryPredicatedevice K960889SapphirePlus@ Tips	ReferencePredicatedeviceK053178Symmetry S-SeriesPiezoelectricScaling Tips	ReferencePredicate deviceK182145tün® ultrasonictips ProductFamily	comment
	2. Clean andirrigate rootcanals.		application ofanultrasonicvibrating tipto the teeth.	and other intra-canal blockages.
DeviceDescription	The device isused duringdental cleaningandperiodontal(gum)therapy to removecalculus depositsfrom teeth byapplication ofultrasonicvibration and invariousendodonticapplications toprepare the teethand /or root of theteeth for repair.	The device isused duringdental cleaningandperiodontal(gum) therapy toremove calculusdeposits fromteeth byapplication ofultrasonicvibration and invariousendodonticapplications toprepare thetooth and /orroot of the toothfor repair.	This device isintended to beused by dentalprofessionalsfor dentalcleaning andperiodontaltherapy toremovecalculus fromthe teeth	tün® ultrasonictips are intendedfor use by dentalprofessionals forthe removal ofsoft and hardtissue duringendodontic rootcanal preparationprocedures. Theycan also aid inthe removal ofendodontic postsand other intra-canal blockages.	SE




OperatingPrinciple	The tips are usedon piezoultrasonicendodontic andscaler units whichoperate in therange of 23kHz-	Used inconjunctionwithpiezoelectricultrasonichandpiece andscaler.	Compatiblewith 27-32kHz generator	tün tips interactwith piezoultrasonic handpiece and unit.tün tips are anaccessory to apiezo ultrasonic	Different


Features	Proposed deviceUltrasonicScaler Tip	PrimaryPredicatedevice K960889SapphirePlus@ Tips	ReferencePredicatedeviceK053178Symmetry S-SeriesPiezoelectricScaling Tips	ReferencePredicate deviceK182145tün® ultrasonictips ProductFamily	comment
	33kHz.	Ultrasonicenergy vibratestip at highfrequencies (upto 40,000 Hz)		hand piece andunit.tün tips are usedon piezoultrasonicendodontic andscaler unitswhich operate inthe range of20,000hz –35,000hz.
TipShapes/Types	GD series and PDseries(except forPD4D) are usedto removecalculus depositsfrom teeth; PD4Dand ED1 are usedfor root canalindication.	Four differenttypes of tips willbe manufacturedas follows:Scaler tips,Plugger Tips,Cutting Tips,Spreader Tips		1 tip design isdevised for postremoval; theremaining 5 tipsare designed fornegotiating thevarious anglesand directions ofroot canals.	Different
Composition	Stainless Steel30Cr13Nickel TitaniumAlloy(endo files)	13-8 stainlesssteel		17-4ph StainlessSteel	Different
Coatings	None	Titanium NitrideZirconiumNitride		Nickel Plating orDiamond NickelPlating	Different
Interactionwith otherproductsand/or itemsused with theproduct	brands of Piezo-Electric typedental ultrasonicScalers that usean M3x0.6 thread			brands of Piezo-Electric typedental ultrasonicScalers that usean M3x0.5 orM3x0.6 thread	Same
Features	Proposed deviceUltrasonicScaler Tip	PrimaryPredicatedevice K960889SapphirePlus@ Tips	ReferencePredicatedeviceK053178Symmetry S-SeriesPiezoelectricScaling Tips	ReferencePredicate deviceK182145tün® ultrasonictips ProductFamily	comment
Sterilization	Provided non-	Provided non-	Provided non-	Provided non-	Same
Status	sterile.	sterile.	sterile.	sterile.
Sterilizationmethod	steamsterilizationSterilizationrequirements: 4minutes at132 °C adrying time ofminimum 20minutes	Yes, no detailinformation	Steam sterilizefor at least 4minutes at270 °F /132 °C or 30minutes at250 °F /121 °C. Donot heat above275 °F /135 °CRecommendat least 30minute drytime aftersterilizationcycle	Gravity SteamSterilizer:• Temperature:250°F /121°C.• Cycle Time: 30minutes• Maximum DryTime: 30 minutesPrevacuumSteam Sterilizer:• Temperature:270°F/132°C.• Cycle Time: 4minutes• MaximumDry Time: 30minutes	Different
Mechanismof treatment	Application of anultrasonicvibrating scalertip to the teeth	Application ofan ultrasonicvibrating scalertip to the teeth	Application ofan ultrasonicvibratingscaler tip tothe teeth	Application of anultrasonicvibrating scalertip to the teeth	Same

Comparison to the Predicate Device 7.

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Section 5_510(k) Summary

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Section 5_510(k) Summary

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Performance Data 8.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Ultrasonic Scaler Tips was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Section 5_510(k) Summary

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process". The biocompatibility testing included the following tests:

Cytoxicity
Skin Sensitization
Irritation
Acute Systemic Toxicity
Material-mediated Pyrogens

Reprocessing Validation

Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products - moist heat - Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings.

Bench Performance Testing

Testing was conducted to demonstrate conformity to the applicable clauses of the following standards:

. ISO 18397 Dentistry Powered scaler
ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments

Clinical data

The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence.

9. Conclusion

Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, the subject ultrasonic scaler tips are considered to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.