C-Sailor Pro: This device is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-PUMA MASTER: The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth. This device is designed for use by a trained professional in the filed of general dentistry.

Device Description

The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation.

The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Dental Implantation Systems, Dental Electrical Motors." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing and comparison of technical specifications.

It's crucial to understand that this document does not describe a study involving an AI/ML algorithm or its performance criteria. The device in question is a dental electromechanical system, not a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the types of acceptance criteria and performance studies detailed in the prompt's request.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this submission.

However, I can extract information related to the closest concept of "acceptance criteria" and "study" as presented for this type of medical device submission.

Acceptance Criteria and Device Performance (as inferred from a 510(k) for an electromechanical device)

For this type of device, "acceptance criteria" are typically the standards compliance and functional equivalence to the predicate device. The "study" proving this involves non-clinical bench testing to demonstrate adherence to specific performance and safety standards, and a comparison of key technical specifications with the predicate device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred from standards and predicate comparison)	Reported Device Performance / Compliance
Safety and Essential Performance (Electrical)	Complies with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014 (Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests).
Particular Requirements for Dental Equipment	Complies with IEC 80601-2-60:2019 (Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment).
Handpieces and Motors (Mechanical/Functional)	Complies with ISO 14457 Second edition 2017-10 (Dentistry - Handpieces and motors). Tested for the performance of Dimensions.
Biocompatibility (Cytotoxicity)	Complies with ISO 10993-5 (Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity). Test results showed no biocompatibility risk.
Biocompatibility (Irritation & Skin Sensitization)	Complies with ISO 10993-10 (Biological evaluation of medical device - Part 10: Tests for irritation and skin sensitization). Test results showed no biocompatibility risk.
Risk Management Application	Complies with ISO 14971 (Medical devices - Application of risk management to medical devices).
Intended Use Equivalence	Same as predicate device (dental oral surgery and dental implant).
Indications for Use Equivalence	Same as predicate device (Prescription Use, dental oral surgery, dental implant).
Memory	8 Pre-set implant systems (Same as predicate).
Micromotor Torque	C-Sailor Pro: 5 - 80Ncm; C-PUMA MASTER: 0.6-5.1Ncm (Predicate: 5 - 80Ncm. Explained difference does not raise risk).
Maximal Speed	C-Sailor Pro: 300r/min~~40000r/min; C-PUMA MASTER: 2000~~40000rpm (Predicate: 200-40,000 min-1. Explained difference does not raise risk).
Handpiece Coupling	ISO 3964 (Same as predicate).
Handpiece Chuck Mechanism	Push-button (Same as predicate).
Bur Compatibility	Type and dimension of shank and minimum fitting length of shank in accordance with ISO 1797 (Same as predicate: Ø 2.35mm/ Type 1 (ISO 1797)).
Foot Control Degree of Protection	IPX7 (Predicate: IPX8. Explained difference does not raise risk and complies with IEC 80601-2-60 safety requirements).

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

Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases, as no clinical study was conducted. For non-clinical bench testing, the "sample size" would refer to the number of devices or components tested. This is typically determined by the testing standard requirements but is not explicitly stated here (e.g., "1 device tested for electrical safety," etc.).
Data Provenance: The data comes from non-clinical bench testing performed by the manufacturer (Foshan COXO Medical Instrument Co., Ltd.) in China. The testing validates compliance with international standards (e.g., ANSI, IEC, ISO). The tests were conducted to verify that the device "met all design specifications" and was "Substantially Equivalent (SE) to the predicate device." It is retrospective in the sense that it's a report of completed tests, not prospective patient enrollment.

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

Not Applicable. For this type of electromechanical device and 510(k) submission, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" in this context is the compliance with engineering and safety standards, verified through objective laboratory measurements and tests, and the functional specifications of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert readings for diagnostic accuracy studies. This submission relies on objective engineering and performance conformity with standards and the predicate device.

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

No. No clinical study, and therefore no MRMC study, was conducted or submitted. The document explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is an electromechanical dental device, not an algorithm. Therefore, "standalone algorithm performance" is not a concept relevant to this submission.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:
- Compliance with recognized international standards (e.g., ANSI, IEC, ISO) for medical device safety, electrical performance, EMC, biocompatibility, and specific dental equipment requirements.
- Technical specifications and performance data of the legally marketed predicate device (NAKANISHI INC.'s Surgic Pro, Surgic Pro+ K173905).
- Bench test results demonstrating the proposed device's adherence to its design specifications and functional equivalence.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of an AI/ML algorithm. This is an electromechanical device.

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

Not Applicable. As there is no training set, there is no ground truth establishment for one.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

September 27, 2022

Foshan COXO Medical Instrument Co., Ltd. % Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA

Re: K220831

Trade/Device Name: Dental Implantation Systems, Dental Electrical Motors Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW, KMW, EGS Dated: July 15, 2022 Received: July 18, 2022

Dear Ray Wang:

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.

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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) 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 (QS) 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.

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) K220831

Device Name

Dental Implantation Systems/Dental Electrical Motors

Indications for Use (Describe)

C-Sailor Pro:

This device is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-PUMA MASTER:

The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth.

This device is designed for use by a trained professional in the filed of general dentistry.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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The assigned 510(k) Number: __K220831

510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 07/15/2022
1. Sponsor Identification

Foshan COXO Medical Instrument Co., Ltd.

BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226, Guangdong, China

Contact Person: Zheng Yongjian Position: Legal Representative Tel: 13702544788 Fax: 0757-81800058 Email:13702544788@163.com

Designated Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

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4. Identification of Proposed Device

Trade Name: Dental Implantation Systems, Dental Electrical Motors Common Name: Controller, Foot, Handpiece And Cord; Handpiece, Rotary Bone Cutting; Handpiece, Contra- And Right-Angle Attachment, Dental

Regulatory Information Classification Name: Dental Classification: 2 Product Code: EBW, KMW, EGS Regulation Number: 872.4120 Review Panel: Dental

Device Description:

The two models of proposed device have the same operating principle shown as following:

The functions corresponding to the dental operation steps are preset by the mainframe or pedal switch, and the electric energy and signals are transmitted to the motor through the motor cable, the motor drives the motor handle, and the motor handle drives the dental surgical instruments to carry out the operation.

Intended Use:

C-Sailor Pro:

It must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-PUMA MASTER:

The Dental Electrical Motor is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

This device is designed for use by a trained professional in the filed of general dentistry.

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Predicate Device 510(k) Number: K173905 Product Name: Surgic Pro, Surgic Pro+ Manufacturer: NAKANISHI INC.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
EC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests;
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
ISO 10993-5 Biological evaluation of medical device -Part 5: Tests for in vitro cytotoxicity. A
ISO 10993-10 Biological evaluation of medical device - Part 10: Tests for irritation and skin sensitization.
A ISO 14971 Medical devices - Application of risk management to medical devices
Bench Testing for the performance of Dimensions.
1. Clinical Test Conclusion

No clinical study is included in this submission.

ITEM	Proposed Device	Predicate Device K173905	Remark
Intended Use	C-Sailor Pro:This device is intended for use in dental oralsurgery and dental implant. The main unit isdesigned to be used with a specific dentalmicromotor that drives dental handpieces fittedwith appropriate tools to cut hard tissues in themouth.It must only be used in hospital environments,clinics or dental offices by qualified dentalpersonnel.C-PUMA MASTER:	Surgic Pro+ / Surgic ProThe Surgic Pro+ / Surgic Pro is intendedfor use in dental oral surgery and dentalimplant. The main unit is designed to beused with a specific dental micromotorthat drives dental handpieces fitted withappropriate tools to cut hard tissues inthe mouth.The SG20 and X-SG20LThis medical device is for oral surgeryand dental implant operation. This device	SAME

	The Dental Electrical Motor is intended for use indental oral surgery and dental implant. The mainunit is designed to be used with a specific dentalmicromotor that drives dental handpieces fittedwith appropriate tools to cut hard tissues in themouth.This device is designed for use by a trainedprofessional in the filed of general dentistry.	is driven by an electronic micromotor fororal surgery and dental implant. Thedevice is intended to transmit therotation of the power source at differentgear ratios, thereby moving instrumentssuch as surgical burs or surgical drills tocut the maxilla / mandible during oralsurgery and dental implant.
Indications for Use	Prescription Use, dental oral surgery, dentalimplant	Prescription Use, dental oral surgery,dental implant	SAME
Package Contents	HostFoot Control (With Cable)AC Electrical CordMotor (With Cable)StandHandpiece StandTube HolderSpare FuseHandle(Foot control)Irrigation tubing set	Control UnitMicromotor (Optic or Non-Optic)Foot ControllerHandpiece (Optic or Non-Optic)Irrigation tube (5 pcs)Operation Manua	Analysis 1
Memory	8 Pre-set implant systems	8 Pre-set implant systems8 user definedof 8 steps each	SAME
Micromotor Torque	C-Sailor Pro: 5 - 80NcmC-PUMA MASTER: 0.6-5.1Ncm	5 - 80Ncm	SAME
Maxima speed	C-Sailor Pro: 300r/min~~40000r/minC-PUMA MASTER: 2000~~40000rpm	200-40,000 min-1	Analysis 2
Speed ratio option	C-Sailor Pro: 64:1, 20:1, 16:1, 10:1, 4:1, 1:1, 1:5C-PUMA MASTER: 16:1, 1:1, 1:5	Not available	Analysis 3
Discharge	C-Sailor Pro: ≥50ml/minC-PUMA MASTER: ≥50ml/min(200kPa)	Not available
Spray gas flow rate	C-Sailor Pro: /C-PUMA MASTER: ≥1.5L/min(200kPa)	Not available
Cooling gas flow	C-Sailor Pro: /C-PUMA MASTER:<40L/min(250kPa-500kPa)	Not available
Adapter	C-Sailor Pro: /C-PUMA MASTER:Input: 100V-240V~ 50/60Hz 2.5AOutput: 29.5V~4.8A	Not available
Classification ofdegree of protection	C-Sailor Pro: Type BC-PUMA MASTER: Type B	Not available

against electricshock
Classification oftypes of protectionagainst electricshock	C-Sailor Pro: Class IIC-PUMA MASTER: Class II	Not available
light source	C-Sailor Pro: LED 3.3VC-PUMA MASTER: LED 3.3V	Not available
Handpiece Coupling	ISO 3964	ISO 3964	SAME
Handpiece ChuckMechanism	Push-button	Push-button	SAME
Bur	Type and dimension of shank and minimumfitting length of shank in accordance with ISO1797	Ø 2.35mm/ Type 1 (ISO 1797)	SAME
Foot Control Degreeof Protection	IPX7	IPX8	Analysis 4

8. Substantially Equivalent (SE) Comparison

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Analysis 1:

The proposed device is different with the predicate device in package contents, which may raise the risk about biocompatibility, for this risk we have conducted the testing according to the ISO 10993-1, cytotoxicity, irritation and sensitization. The test results shown that no biocompatibility risk would be raised.

So, we consider that the proposed device has same biocompatibility performance with the predicate device.

Analysis 2:

The proposed device is different with the predicate device in Micromotor Torque, but the intended use is the same, for this risk we have conducted the ISO 14457 Test Report, EMC Test Report and IEC 80601-2-60 Test Report, the test results shown the difference does not raise any risk.

Analysis 3:

We are not sure whether the proposed device and the predicate device are exactly the same in Speed ratio option, Discharge, Spray gas flow rate, Cooling gas flow, Adapter, Classification of degree of protection against electric shock, Classification of types of protection against electric shock and light source, because we can't get the technical specifications for predicate device, but the intended use is the same, for this risk we have conducted the ISO 14457 Test. EMC Test and IEC 80601-2-60 Test, the test results shown the difference does not raise any risk.

Analysis 4:

The proposed device is different with the predicate device in foot control degree of protection, which may raise the risk about safety, for this risk we have conducted the testing according to the IEC 80601-2-60. The test results shown that the proposed device conforms to IEC 80601-2-60. So, both the proposed device and the predicate device meet the safety requirements of IEC

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80601-2-60.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) 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.