The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.

Device Description

This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "The Trust," which measures the stability of dental implants. To answer your request about acceptance criteria and the study proving the device meets them, I need to focus on the "Performance Data" section and the "Comparison Technological Characteristics with the Predicate Devices" table, as these are the most relevant parts.

Here's a breakdown based on the information provided and common expectations for such submissions:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table with specific pass/fail values. Instead, the document relies on demonstrating "similar performance" to a predicate device and meeting "established specifications." The key performance characteristic mentioned is the "Error of measurement value."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance (The Trust)
Error of measurement value: ≤ ±3 ISV (Implied, matching predicate)	±3 ISV
Angle deviation alarm functionality	Alarm sounds when out of angle of use (Setting angle 0~90°)
Tapping Strength	Under 3N
Tapping Times	7 times
Tapping Duration per time	0.3 sec / 1 time
Biological Safety (Biocompatibility)	Non-toxic, non-sensitizing to biological bone and tissues (Met ISO 10993 standards)
Compliance with Electrical/Mechanical Standards	Meets IEC 60601-1
Usability (Auto Power off)	120sec (±10%)
Continuous operation mode	Continuous Operation
Display functionality	Power ON display, Operation display, Start Charging display, ISV scale display (1~99), Operating Error display, Charging error display
Commands/Functionality	Power ON, Measurement, Power OFF

Study Information:

Based on the provided text, the study proving the device meets the acceptance criteria is primarily an equivalence test to the predicate device (AnyCheck IMT-100), rather than an independent clinical study with human subjects.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample size used for the performance comparison tests. It mentions "performance comparison tests with already licensed products" (refer to "002 Equivalence test to AnyCheck"). This often implies bench testing or testing on phantom models, rather than a large clinical test set with patient data.
- Data Provenance: Not specified. Given it's a Korean manufacturer, it's likely the testing was conducted in South Korea. The type of study (retrospective or prospective) is not explicitly stated, but equivalence testing of this nature for dental handpieces typically involves prospective bench-top testing.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. For this type of device and performance testing, ground truth would likely be established by controlled experimental setups and direct measurement by engineers/technicians, rather than expert review of images or clinical outcomes.
Adjudication Method for the Test Set:
- Not applicable/Not specified. As the "ground truth" is likely derived from calibrated measurements in a controlled environment, there wouldn't typically be a need for expert adjudication in the way it's used for AI diagnostic studies.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is typically performed for AI-driven diagnostic devices where human readers interpret medical images. This device measures implant stability mechanically. There is no indication of such a study being conducted or required.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.
Standalone (Algorithm Only) Performance:
- Yes, implicitly. The "Performance Data" section refers to tests to ensure the device met "established specifications" and "consistent performance for the intended use." This strongly suggests bench testing or in vitro (non-human) testing of the device's measurement capabilities, which would be considered standalone performance. The "±3 ISV" error of measurement is a standalone performance metric.
Type of Ground Truth Used:
- Likely bench-top measurements / calibrated experimental setup. The device measures a physical property (time between abutment and striking rod, quantified as ISV). The "ground truth" for evaluating its accuracy would come from highly controlled conditions where the "true" stability or a reference value is known (e.g., using standardized implant models with predefined stability levels or comparing to a gold standard measurement technique). It is not pathology, expert consensus, or outcomes data.
Sample Size for the Training Set:
- Not applicable/Not specified. This device is described as a mechanical measurement device using an acceleration sensor, not an AI/machine learning device that requires a "training set" in the conventional sense. The "principle to measure the contact time according to the acceleration change... by using the acceleration sensor mounted on the Attack Pole" suggests a direct physical measurement.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there's no indication of a "training set" for an AI algorithm.

Summary of Device Performance Test and Conclusion:

The performance evaluation for "The Trust" appears to have focused on demonstrating its technical accuracy and equivalence to a legally marketed predicate device (AnyCheck IMT-100). The key performance metric highlighted is the "Error of measurement value" of ±3 ISV, which matches that of the predicate. The submission argues that similarities in operational principles and biological safety, despite minor design differences (e.g., how the calibrator is integrated, magnetic vs. screw connection for the attack pole), do not raise new questions of safety or effectiveness. Biocompatibility testing was also conducted according to ISO 10993 standards and found the materials to be non-toxic and non-sensitizing.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

August 9, 2024

Genoss Co., Ltd Jiyeon Lee RA staff 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do SOUTH KOREA

Re: K222688

Trade/Device Name: The Trust Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: July 16, 2024 Received: July 16, 2024

Dear Jiyeon Lee:

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

510(k) Number (if known) K222688

Device Name The Trust

Indications for Use (Describe)

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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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The font is bold and sans-serif, with the "O" in "OSS" having a unique design where the top part of the "O" is open and connects to the "S".

510(k) Summary

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	Head Office: 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu,Suwon-si, Gyeonggi-do, KoreaManufacturing site: D-Factory, 56, Changnyong-daero 256 beon-gil,Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax	+82-70-7098-7573
Contact person	Jiyeon Lee / RAjylee3@genoss.com
Summary Date	8/6/24

2. Device Name

Proprietary name:	The Trust
Regulation description:	Dental Implant stability measuring device
Classification name:	Handpiece, Direct Drive, AC-Power

3. Predicate Device

K180953	AnyCheck IMT-100
---------	------------------

4. Description

5. Indication for use

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Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter, lime green color. The font is bold and sans-serif, with a slightly rounded appearance. The letters are closely spaced, giving the word a compact and unified look.

6. Comparison Technological Characteristics with the Predicate Devices

The Trust was compared to the predicate device, Anycheck IMT-100, from a technical, and biological perspective. The comparison of the predicate device to the subject device does not raise any new questions of safety and effectiveness. The reasons for this are shown in the table below.

	Device name	The Trust	AnyCheck IMT-100
	Manufacture	Genoss Co., Ltd.	DMS Co., Ltd.
	510(K) Number	New device	K180953
	Classification	Class I	Class I
	RegulationNumber	21 CFR 872.4200	21 CFR 872.4200
	ClassificationProduct Code	EKX	EKX
Clinical	Target population	Human Tooth	Human Tooth
	Indication for use	The Trust is restricted to usage withDentium implant system, and the angle ofthe Attack Pole to the abutment must bemaintained at 90° when in use.	The AnyCheck IMT-100 isindicated for use in measuring thestability of implants in the oralcavity and maxillofacial region
	Performance Property	The Trust measures the time whenthe rod hits the installed implantbase by mechanically vibration,and quantifies the stability of theimplant. The contact time is theprinciple of measuring the contacttime according to the change in theacceleration of the moment struckusing the accelerometer mountedon the strike rod. The higher thenumber, the implant stability ismore rigid.	AnyCheck measures the time whenthe rod hits the installed implantbase by mechanically vibration,and quantifies the stability of theimplant. The contact time is theprinciple of measuring the contacttime according to the change in theacceleration of the moment struckusing the accelerometer mountedon the strike rod. The higher thenumber, the implant stability ismore rigid.
	Anatomical Location ofUse	Implant or Abutment	Implant or Abutment
	Anatomical Sites	Root canal, Softened dentin	Root canal, Softened dentin
Technical	Error of measurementvalue	±3 ISV	±3 IST
	Angle deviation	Alarm sounds when out of angle ofuse(Setting angle 0~90°)	Alarm sounds when out of angle ofuse(Setting angle 0~30°)
	Size and Weight	Instrument size:220 x 25 x 27.5 mmInstrument weight: 80g	Instrument size:195 x 31.8 mmInstrument weight: 100g
	Electrical RatedVoltage/Current	DC 3.7V / 0.5A	DC 5V / 1A
	Auto Power off	120sec (±10%)	60sec
	Tapping Strength, Times	Under 3N7 times0.3 sec / 1 time	Less than 1.3N6 times0.5 sec / 1 time

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Image /page/6/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The "GEN" part of the word is in a dark green color, while the "OSS" part is in a lighter green color. The letters are bold and slightly rounded, giving the word a modern and professional look. The overall design is clean and simple, making it easily recognizable.

Components	Front HousingAttack PoleBody – Power and operationbutton, LCD windowUSB ConnectorUSB C-type Cable	AnyCheck Main BodyTapping RodTapping Rod Front GuideON/OFF SwitchLCD DisplayTarget BarTapping Rod Allen WrenchUSB C Type Cable
Rated Voltage	DV 5V (USB C-Type)	DV 5V (USB C-Type)
Operation Mode	Continuous Operation	Continuous Operation
Display	Power ON displayOperation displayStart Charging displayISV scale display (1~99)Operating Error displayCharging error display	ON/OFF displayOperation displayCharging displayIST scale display (0~99),Error display (Error)
Commands/Function	Power ONMeasurementPower OFF	Power ONActionPower OFF
Mechanical/	The Trust is designed and	AnyCheck is designed and
Electrical safety/	manufactured with applicable	manufactured with applicable
Standards	standards: IEC 60601-1	standards: IEC 60601-1
Chemical Safety	Biocompatible	Biocompatible
Cytotoxicity/Oral mucosa irritation/Skin sensitization	According to ISO 10993-5ISO 10993-10ISO 10993-12	According to ISO 10993-5ISO 10993-10ISO 10993-12
Sterilization	User sterilization and disinfection	User sterilization and disinfection

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Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter, lime green color. The font is bold and slightly italicized, giving the word a dynamic and modern appearance.

6.1 Gap Analysis

Gap (1): Accessories for measurement of stability

There are differences in the components of the subject device and the predicate device, but those differences do not affect the safety and effectiveness of this product.

-Tapping Rod: The tapping rod of the predicate device is a component that plays the same role as the attack pole of the subject device, and is a component that measures the stability of the implant by tapping the healing abutment.

-Front Guide Tapping Rod: The Front Guide Tapping Rod in the predicate device is a component that guides the movement of the tapping rod to measure implant stability, and the Front Housing in the subject device performs the same role. Therefore, there are no issues with the safety and effectiveness of the product.

Gap (2): Discussion of the similarities

-Technical: Both the predicate and subject devices are utilized on the implant abutment to measure contact duration by striking it, expressing implant stability numerically. These products are deemed equivalent as they operate on the same principle at the same site.

-Biological: Both the predicate and subject devices are medical devices with components that contact the body. Biological evaluation requirements for both products adhere to the FDArecognized ISO 10993 consensus standard, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." There are no concerns regarding the safety and effectiveness of the product.

Gap (3): Discussion of the difference

Predicate device has a component called a target bar to ensure the accuracy of measurements. Subject device does not include this component. Instead, we included a calibrator within the subject device. Subject device derives measurement values by calculating the contact time between the abutment and the Attack Pole, but when operating in the air, its movement is stopped by a component called a Collar spacer. Because the attack pole does not touch the object, contact time cannot be calculated. Therefore, the measurement will be 0 and the user can assume that the machine is operating normally. Therefore, if the measured value is displayed as 0 when operating in the air, it is operating normally. In conclusion, a calibrator like the Target Bar on the predicate device is built into the subject device.

In the case of predicate device, the tapping rod and the main body are connected by screwing, so an Allen wrench is used to ensure a firm connection. However, in the case of subject, the Attack Pole and the body are connected by magnets, so there is no need for separate connection parts. This difference in parts does not affect the effectiveness or safety of the product.

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Image /page/8/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The "GEN" part of the word is in dark green, while the "OSS" part is in a lighter, lime green color. The font is bold and slightly italicized, giving the word a dynamic and modern appearance. The overall design is clean and simple, with a focus on the typography.

7. Biocompatibility Data

Biocompatibility testing on the proposed The Trust has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use.

8. Performance Data

All test results show that the materials, manufacturing processes and design used in The Trust met established specifications required for consistent performance for the intended use. Additionally, performance comparison tests with already licensed products confirm that the two products have similar performance (refer to 002 Equivalence test to AnyCheck). Therefore, there is no effect on the safety or effectiveness of this device.

9. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that comparing the two devices does not raise new questions about safety and effectiveness.

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.