TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.

AI/ML Overview

This document is a 510(k) Summary for the TRAUS SUS20, a piezo surgery engine set. It details the device's characteristics and its substantial equivalence to a predicate device, TRAUS SUS10. Since this is a submission for a medical device (bone cutting instrument), the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than a quantifiable performance metric (like sensitivity or specificity) for a diagnostic AI. The study presented here is primarily a comparison of technical characteristics and compliance with recognized standards, and not a clinical study involving human subjects or AI-specific performance metrics.

Here is an analysis based on your request, as much as can be extracted from the provided text for a non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device. "Device performance" is shown through bench testing of key operational parameters.

Acceptance Criteria (Demonstrated Equivalence/Compliance)	Reported Device Performance/Compliance
Intended Use	TRAUS SUS20: Intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.
Principle of Operation	TRAUS SUS20: Piezoelectric ultrasonic vibrations to perform in dental surgery. (Identical to predicate device)
Electrical Safety	Complies with IEC 60601-1:2005 + A1:2012, IEC 80601-2-60:2012.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014.
Software Validation (Firmware)	Designed and developed according to a software development process, verified and validated. (MODERATE level of concern software)
Biocompatibility	Handpiece: Materials and manufacturing process identical to predicate device (K151171). Ultrasonic Tips: Complies with ISO 10993-1, -5, -10, -12.
Sterilization (User performed)	Validated in accordance with ISO 17665-1 (for piezo handpiece, ultrasonic tip, and torque).
Nonclinical Performance (Bench Test)	Evaluated piezo output frequency (27 ± 3KHz, identical to predicate), piezo output power (59 VA, identical to predicate), and irrigation water flow rates (Max. 110Q/min ± 20%, comparable to predicate's Max. 90Q/min ± 20%). (According to SOPs).
Substantial Equivalence	Concluded that the subject device is substantially equivalent to the predicate device (TRAUS SUS10, K151171) based on identical product code, regulation number, classification, indications for use, principle of operation, and similar design specifications. Differences (Max. irrigation volume, optic handpiece, specific ultrasonic tips) do not raise new questions of safety and effectiveness.

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

This document describes a premarket notification (510(k)) for a conventional medical device, not an AI device or a diagnostic test involving a "test set" of patient data in the typical sense.

Sample Size: Not applicable. The "test set" refers to the physical device components and their performance in bench tests (e.g., electrical safety, EMC, performance parameters) and comparison with a predicate device. The performance tests would use a sample of the manufactured device.
Data Provenance: Not applicable in the context of patient data. The provenance of the data for this submission would be internal testing reports, external testing laboratory reports (for standards compliance), and comparison data from the predicate device (TRAUS SUS10, K151171) and a reference device (Compact Piezo LED, K151023) from Saeshin Precision Co., Ltd. and Mectron Spa, respectively. Given the context of a 510(k) submission, this data is generally prospective in terms of the testing done for the new device, but relies on existing data for the predicate devices.

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

Not applicable for this type of device submission. "Ground truth" in the context of diagnostic AI refers to clinically validated diagnoses from expert readers, pathology reports, or robust outcome data. For the TRAUS SUS20, the "ground truth" for the performance tests would be the established scientific and engineering principles behind accurate measurement and functional operation, validated by qualified engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret images/data and then reconcile disagreements, which is not relevant for this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices, particularly in medical imaging, to assess reader performance with and without an AI aid across multiple cases and readers. The TRAUS SUS20 is a surgical instrument, not a diagnostic device.

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

Not applicable. This device is a physical surgical engine set, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable. The "truth" for this device rests on:

Engineering Specifications and Standards: The device performs according to its design specifications (e.g., vibration frequency, output power) and meets recognized international standards for electrical safety, EMC, and biocompatibility.
Predicate Device Equivalence: The functional and safety characteristics are demonstrated to be substantially equivalent to an already legally marketed device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the computational sense.

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

Not applicable, as no training set exists for this device.

Summary

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July 13, 2020

Saeshin Precision Co., Ltd. Jong Choi Quality Manager 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 42921 Kr

Re: K192561

Trade/Device Name: TRAUS SUS20 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI Dated: June 18, 2020 Received: June 25, 2020

Dear Jong Choi:

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

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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 medical devices and radiation-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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K192561

Device Name TRAUS SUS20

Indications for Use (Describe)

TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

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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Image /page/3/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape resembling a stylized letter 'S' above the word "SAESHIN" in a bold, sans-serif font, also in blue. The geometric shape is made up of several smaller, interconnected diamond-like shapes, creating a three-dimensional effect.

K192561 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 10, 2020

1. Applicant / Submission Sponsor

Saeshin Precision Co., Ltd. Address: #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu 42921 Republic of Korea Fax : +82-53-580-0939 Tel : +82-53-587-2345

2. Submission Correspondent

DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: dhlee@kmcerti.com

3. Device Identification

Trade/Proprietary Name: TRAUS SUS20 -
-Classification Name: Bone cutting instrument and accessories.
Classification Regulation: 21CFR872.4120 -
Product Code: DZI -
-Device Class: 2
-Review Panel: Dental

4. Predicate Device

K number: K151171
-Manufacturer: Saeshin Precision Co., Ltd.
Trade Name: TRAUS SUS10

(Reference Device: Compact Piezo LED, K151023)

5. Device Description

TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.

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Image /page/4/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in blue block letters. The geometric shape is made up of several smaller blue shapes that are arranged to form a larger cube-like structure. The logo is simple and modern, and the blue color gives it a sense of professionalism and trustworthiness.

When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to set such as power (output intensity) and boost (vibration frequency).

6. Intended use / Indications for Use

TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

7. Substantial Equivalence

The subject device, TRAUS SUS20 is derived from the predicate device, TRAUS SUS10. The predicate device. TRAUS SUS10 has two functions as a piezo ultrasonic dental surgery function and a motor based dental surgery function. The subject device, TRAUS SUS20 has only piezo ultrasonic surgery function and it is the same as the predicate device.

TRAUS SUS20 is substantially equivalent to the predicate device, TRAUS SUS10 (K151171), in which the principle of operation, intended use, technological characteristics and performance characteristics are same. The differences have been verified and the result shows that it does not raise any new questions of safety and effectiveness. The reference device K151023 is used for substantial equivalence comparison of the LED functionality only.

The following comparison table is presented to demonstrate substantial equivalence.

-	Subject Device	Predicate Device	Reference Device	Comparison
Manufacturer	Saeshin Precision Co.,Ltd.	Saeshin Precision Co.,Ltd.	Mectron Spa	-
Device Name	TRAUS SUS20	TRAUS SUS10	Compact Piezo LED	-
510(k) number	-	K151171	K151023	-
ClassificationProduct Code /RegulatoryNumber	DZI / 872.4120	DZI / 872.4120	ELC / 872.4850	Identical toPredicateDevice
SubsequentProduct Code	None	EGS, EBW	Non	-
RegulatoryClass	2	2	2	Identical toPredicateDevice
Indications forUse	TRAUS SUS20, PiezoSurgery Engine Set, isintended for use indental surgeryincluding: osteotomy,osteoplasty,periodontal surgeryand implantation.	TRAUS SUS10, PiezoSurgery and ImplantEngine Unit, is intendedfor use in dental surgeryincluding:osteotomy, osteoplasty,periodontal surgery andimplantation (forultrasonic surgery), andimplantology, maxilla-facial surgery andendodontics fortreatment of dental hardtissue and mechanicalrotating root canalpreparation (for dental	The Compact PiezoLED is an ultrasonicscaler intended foruse, with theappropriateassociated insert tips,in the followingdental applications:• Scaling: Proceduresfor removal ofsupragingival/subgingival andinterdentalcalculus/plaquedeposits:· Periodontology:	Verysimilar toPredicateDevice
		implant surgery).	Periodontal therapyand debridement forperiodontal diseases,including periodontalpocket irrigation andcleaning;• Endodontics:Treatments for rootcanal reamingirrigation, revision,filling, gutta-perchacondensation andretrogradepreparation;• Restorative andProsthetics:Restorativeproceduresincluding cavitypreparation,removal ofprostheses,amalgamcondensation,finishing of crownpreparations,inlay/onlaycondensation andimplants/restorationscleaning.
Prescription orOTC	Prescription	Prescription	Prescription	Identical toPredicateDevice
PrincipleofOperation	Piezoelectric ultrasonicvibrations to performin dental surgery	Piezoelectric ultrasonicvibrations to perform indental surgery	Piezoelectricultrasonic vibrationsto perform in dentalsurgery	Identical toPredicateDevice
Device Design - Control box
Model Name	TRAUS BUS20	TRAUS XUS10	None	Identical toPredicateDevice
Input Power	AC 100-120V, 50 / 60Hz, 48VA	AC 100-120V, 50 / 60Hz, 48VA	None	Identical toPredicateDevice
Max. IrrigationVolume	Max. 110Q/min ±20%	Max. 90Q/min ± 20%	None	Identical toPredicateDevice
Device Design - Piezo Handpiece
Model Name	TRAUS PEZ10XX(Non-optic),TRAUS PEZ10LN(Optic)	TRAUS PEZ10XX(Non-optic)	COMPACT PIEZOLED	-
Vibrationfrequency	27 ± 3KHz	27 ± 3KHz	24 kHz to ~36 kHz	Identical toPredicateDevice
Maximumoutputpower of piezooperation	59 VA	59VA	59VA	Identical toPredicateDevice
LED systemincorporatedinsidethehandpiece toprovideillumination oftheoperativesite	Yes(only for TRAUSPEZ10LN / 2,400 lux)	None	Yes	Identical toReferenceDevice
Device Design - Ultrasonic Tip (Not provided)
Model Name	FDA listed accessory(Listing numberD250061)SP-028iSP-024iSP-016SP-SAWSP-SAW LSP-SAW RSP-320SP-400SP-610SP-020is	FDA listed accessory(Listing numberD250061)SP-028iSP-024iSP-016SP-SAWSP-SAW LSP-SAW RSP-320SP-400SP-610SP-100SP-020is	FDA listed accessoryOT7OT7S-3OT7S-4OT8ROT9L	Identical toPredicateDevice
Material(incontactwithpatient)	Trimrite	Trimrite	Trimrite	Identical toPredicateDevice
Device Design - Foot Controller
Model Name	TRAUS FUS10	TRAUS FUS10	NA	Identical toPredicateDevice
Degreeofprotectionagainst ingressof water (IEC60529)	IPX8	IPX8	NA	Identical toPredicateDevice
Accessories
HandpieceStand	Part No. 2017STANDER	Part No. 2011 STAND	NA	Identical toPredicateDevice
Hanger	Part No. X-CUBE 06	Part No. X-CUBE 06	NA	Identical toPredicateDevice
Tube Holder	Part No. FORTE100aEI 05	Part No. FORTE100aEI 05	NA	Identical toPredicateDevice
Torque wrench	Part No. TRAUSATW10	Part No. TRAUSATW10	NA	Identical toPredicateDevice
Tip Holder	Part No. TRAUSATH10	Part No. TRAUSATH10	NA	Identical toPredicateDevice
SterilizationCase	Part No. TRAUSATR10	Part No. TRAUSATR10	NA	Identical toPredicateDevice
Power Cord	Part No. BC-02	Part No. BC-02	NA	Identical toPredicateDevice
(Optional)Irrigation Tube	* FDA listedaccessory. (Listing No:D289551)Part No. DB-001,Part No. DB-003	* FDA listed accessory.(Listing No: D289551)Part No. DB-001,Part No. DB-003	NA	Identical toPredicateDevice

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Image /page/5/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape above the company name. The geometric shape is made up of several smaller shapes that are arranged to form a larger, more complex shape. The company name is written in a stylized font.

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Image /page/6/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a blue geometric shape resembling a stylized letter 'S' above the word "SAESHIN" in blue, blocky letters. The geometric shape is made up of several smaller cubes or parallelograms arranged to create a three-dimensional effect.

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Image /page/7/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized, sans-serif font, also in blue. The geometric shape appears to be composed of several smaller cubes or parallelograms arranged to form a larger, more complex shape.

8. Electrical Safety and Electromagnetic compatibility

The Electrical Safety and Electromagnetic Compatibility tests were performed in accordance with the following standards.

IEC 60601-1:2005 + A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 80601-2-60:2012, Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dentalequipment
IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

9. Software Validation:

TRAUS SUS20 contains MODERATE level of concern software (firmware). The software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices.

10. Biocompatibility

TRAUS SUS20 is supplied with piezo handpiece which can contact with a patient. The handpiece has been evaluated about biocompatible throughout previous FDA clearance (K151171) as the materials and manufacturing process are identical to the company's own predicate device.

The ultrasonic tips which also can contact with a patient are FDA listed accessories(Listing number D250061). The biocompatibility test for the tips were performed in accordance with the following FDA recognized standards

-ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

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Image /page/8/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized, blue font. The geometric shape is made up of several smaller shapes, creating a three-dimensional effect.

-ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

10. Sterilization

The piezo handpiece, ultrasonic tip and torque are sterilized by the user prior to use. The sterilization was validated in accordance with the standard ISO 17665-1.

11. Nonclinical Performance Test - Bench Test

For nonclinical performance testing - Bench test, piezo output frequency, Piezo output power and Irrigation water flow rates were evaluated according to SOP.

12. Clinical Testing

No clinical study was considered necessary and performed.

13. Conclusion

Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as Product Code, Regulation number, Classification, Indications for use, Principle of Operation and Design Specification (Maximum output power of piezo operation and Vibration frequency). A piezo handpiece (TRAUS PEZ10XX) and foot controller (TRAUS FUS10) are identical to the predicate device. Although there are some differences Control box - Max. irrigation volume, a handpiece with optic function, ultrasonic tips), the performance test reports are supported to the substantial equivalence of the subject device. The differences of the subject device do not raise different questions of safety and effectiveness. The subject device follows the recommendations of the FDA Guidance Document Dental Handpieces - Premarket Notification [510(k)] Submissions.

In this regard, we conclude that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.