The Surgic Pro2 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.

Device Description

The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.

The Surgic Pro2 is intended 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 cut hard tissues in the mouth.

Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad.

The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.

The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.

AI/ML Overview

The provided text is an FDA 510(k) summary for a dental device called "Surgic Pro2." It outlines the device's technical specifications, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The non-clinical tests mentioned are primarily related to general device performance, reprocessing, software life cycle (general, not AI-specific), electrical safety, EMC, and cybersecurity. There is no mention of an AI/ML component or any performance metrics like sensitivity, specificity, or AUC that would typically be associated with AI application acceptance criteria for diagnostic or assistive devices.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria and a study proving the device meets these criteria based on the provided text. The text does not describe such a study or an AI component.

To directly address your request given the provided text's limitations, here's what I can extract and what I cannot:

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

The document mentions validation and verification testing against various standards and guidance documents. These are the "acceptance criteria" for the general device performance and safety. The "reported device performance" is simply that the "results of the exit [sic] the requirements of the following standards and guidance."

Acceptance Criteria (Standards/Guidance Met)	Reported Device Performance
ISO 14457:2017 (Dentistry - Handpieces and motors)	Results met requirements
ISO 17665-1:2006 (Sterilization - Moist heat)	Results met requirements
ISO 17664-1:2021 (Processing of health care products - Part 1)	Results met requirements
ISO 17664-2:2021 (Processing of health care products - Part 2)	Results met requirements
IEC 62304:2006+AMD1:2015 (Medical device software - Software life cycle)	Results met requirements
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Medical electrical equipment - basic safety and essential performance)	Results met requirements
IEC 60601-1-2:2014 (Medical electrical equipment - EMC)	Results met requirements
IEEE/ANSI C63.27:2021 (Evaluation of Wireless Coexistence)	Results met requirements
AAMI TIR57:2016 (Principles for medical device security - Risk management)	Results met requirements
IEC 81001-5-1:2021 (Health software and health IT systems safety, effectiveness and security - Part 5-1: Security)	Results met requirements
FDA guidance document "Dental Handpieces - Premarket Notification [510(k)] Submissions"	Results met requirements
FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"	Results met requirements
FDA guidance document "Content of Premarket Submissions for Device Software Functions"	Results met requirements
FDA guidance document "Cybersecurity in Medical Devices: Quality System Content of Premarket Submissions"	Results met requirements

2. Sample size used for the test set and the data provenance:

Not specified. The document does not provide details on the sample sizes for the performance tests, only lists the standards against which they were tested. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. For the non-clinical tests mentioned (e.g., electrical safety, sterilization), "ground truth" as it applies to clinical data review by experts is not relevant. The conformity to standards would be assessed through engineering and quality testing, not expert clinical review.

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

Not applicable/Not specified. This is relevant for clinical studies with expert reviewers, not for the type of non-clinical device performance and safety testing described.

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:

No evidence of an MRMC study. The document describes a traditional 510(k) pathway for a dental handpiece system, focusing on substantial equivalence based on technical characteristics and non-clinical performance (safety, reprocessing, software lifecycle, etc.), not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. The device described (Surgic Pro2) is a dental surgical system with a micromotor, handpieces, and control unit. While it has software and Bluetooth connectivity (e.g., to display ISQ values from another device), it is not an AI/algorithm-only device for diagnosis or image analysis. Its software controls mechanical functions, not an independent interpretive algorithm.

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

Not applicable/Compliance with standards. For the non-clinical tests performed, the "ground truth" is typically defined by the specified parameters and limits within the engineering standards (e.g., specific electrical leakage limits, torque values, sterilization parameters).

8. The sample size for the training set:

Not applicable. This device is not described as having an AI/ML component that would require a training set.

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

Not applicable. As above, no AI/ML training set is indicated.

Summary

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June 20, 2024

Nakanishi Inc. Mr. Satoru Ikeda Regulatory Affairs Department TIX TOWER UENO 9F 4-8-1. Higashiueno Taito-ku, Tokyo 110-0015 JAPAN

Re: K233117

Trade/Device Name: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: May 21, 2024 Received: May 21, 2024

Dear Satoru Ikeda:

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/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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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

Submission Number (if known)

K233117

Device Name

Surgic Pro2 (Surgic Pro2 OPT); Surgic Pro2 (Surgic Pro2 NON-OPT)

Indications for Use (Describe)

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) #: K233117

510(k) Summary

Prepared on: 2024-06-20

Contact Details

21 CFR 807.92(a)(1)

Applicant Name		NAKANISHI INC.
Applicant Address		700 Shimohinata Kanuma Tochigi 322-8666 Japan
Applicant Contact Telephone		+81-289-64-7277
Applicant Contact		Mr. Masaaki Kikuchi
Applicant Contact Email		nskra@nsk-nakanishi.co.jp
Correspondent Name		NAKANISHI INC.
Correspondent Address		TIX TOWER UENO 9F 4-8-1, Higashiueno Taito-ku Tokyo 110-0015Japan
Correspondent Contact Telephone		+81-358-28-8590
Correspondent Contact		Mr. Satoru Ikeda
Correspondent Contact Email		nskra-contact@nsk-nakanishi.co.jp
Device Name			21 CFR 807.92(a)(2)
Device Trade Name		Surgic Pro2 (Surgic Pro2 OPT);Surgic Pro2 (Surgic Pro2 NON-OPT)
Common Name		Dental handpiece and accessories
Classification Name		Controller, Foot, Handpiece And Cord
Regulation Number		872.4200
Product Code		EBW
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)		Product Code
K173905	Surgic Pro+ / Surgic Pro		EBW
K161957	W&H Implantmed SI-1015 Incl. Accessories		EBW
K161213	XSmart iQ		EBW
Device Description Summary			21 CFR 807.92(a)(4)

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contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.

The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.

The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

Both the Indications for Use for the subject device and the Indications for Use for the predicate device are intended for dental applications, including dental oral surgery and dental implant. The only difference between the Indications for Use is the Device Name

Technological Comparison

The Surgic Pro2 is an AC-electrically powered dental surgical system that transmits power to compatible handpieces and controls their functions. The software allows for the control of the device features such as brightness, coolant flow, rotation direction, program selection, calibration, speed, torque, and sound volume. Surgic Pro2 also provides Foot Control and connection to external devices via a Bluetoothe connection. The subject device shares these technical characteristics with the predicate and reference devices. The proposed device also has some differences in technological characteristics from those of the predicate and reference devices. These differences are only minor, such as basic shape, structure, Bluetooth version, and removal of some accessories, and reflect user preferences, market strategies, and version updates, and do not affect the substantial equivalence of the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

For Surgic Pro2, the following non-clinical tests were performed to support substantial equivalence of the subject device. Performance Test:

The Surgic Pro2 subject instrument was subjected to verification and validation testing for motor performance, reprocessing, software, electrical safety, EMC, and cybersecurity to support substantial equivalence. The results of the exith the requirements of the following standards and guidance.

· ISO 14457:2017 "Dentistry - Handpieces and motors"

· 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"

• ISO 17664-1:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices"

· ISO 17664-2:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices."

· IEC 62304:2006+AMD1:2015 "Medical device software - Software life cycle processes"

• IEC 60601-1:2005+AMD1:2012+AMD2:2020 "Medical electrical equirements for basic safety and essential performance"

· IEC 60601-1-2:2014 "Medical electrical equipments for basic safety and essential performance -

Collateral Standard: Electromagnetic disturbances - Requirements and tests"

· IEEE/ANSI C63.27:2021 "American National Standard forEvaluation of Wireless Coexistence"

· AAMI TIR57:2016 "Principles for medical device security - Risk management"

· IEC 81001-5-1:2021 "Health software and heath IT systems sfety, effectiveness and security - Part 5-1:Security - Activities in the procuct life cycle"

· FDA guidance document "Dental Handpieces - Premarket Notification [510(k)] Submissions"

· FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
· FDA guidance document "Content of Premarket Submissions for Device Software Functions"

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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· FDA guidance document "Cybersecurity in Medical Devices: Quality System Content of Premarket Submissions" Biocompatibility:

No biocompatibility test was required to support the substantial equivalence of the Surgic Pro2."

The performance test results support the substantial equivalence of the subject Surgic Pro2 to the precedent 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.