TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Description

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system.

TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm.

TRUST has no patient contact being a software only device. (stand-alone software)

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental abutment design software called TRUST. However, it does not contain any information regarding acceptance criteria, reported device performance, or any study details like sample size, ground truth establishment, or expert qualifications.

The document primarily focuses on establishing substantial equivalence to a predicate device (Abutment Design, K200100) by comparing intended use, technological characteristics, and hardware/software requirements.

Here's a breakdown of what is and is not present in the provided text:

What is present:

Device Name: TRUST
Indication for Use: "TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device."
Predicate Device: Abutment Design (K200100)
Confirmation of Non-clinical Testing: "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures."
Cybersecurity Analysis: "The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014."
Clinical Testing Statement: "Clinical testing is not a requirement and has not been performed."

What is explicitly missing or not described in the provided text, and therefore cannot be filled in based on this input:

A table of acceptance criteria and the reported device performance. The document states that "All test results have been reviewed and approved, showing the TRUST to be substantially equivalent to the primary predicate device," but it does not provide the specific criteria or the performance metrics themselves.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (While it mentions "software only device," it doesn't quantify its standalone performance or discuss specific studies.)
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Conclusion:

The provided document describes a device (TRUST software) and its intended use, and states that non-clinical testing and cybersecurity analysis were performed to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific details of acceptance criteria, device performance, or study methodology that would be required to complete the requested table and information points about test and training sets, ground truth, and expert evaluation.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

7/18/2023

Rgorithm Korea % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro Geumcheon-gu, Seoul 08503 Korea, South

Re: K221107

Trade/Device Name: TRUST Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: June 29, 2023 Received: June 30, 2023

Dear Sanglok 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 (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

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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 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,

Sherrill Lathrop Blitzer

Andrew Steen for 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

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Indications for Use

510(k) Number (if known) K221107

Device Name TRUST

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) Summary – Traditional 510(K)

The assigned 510(k) Number: K221107

01. Date of Submission: July 17, 2023

02. Applicant / Submitter

Roorithm Korea A-1502, 606 Seobusaet-gil, Geumcheon-gu, Seoul, 08504, Republic of Korea Tel. +82 2 6264 4688

03. Submission Correspondent

Sanglok. Lee Wise COMPANY Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: +82 2 831 3615 Email: info@wisecompany.org

04. Proposed Device Identification

Device Identification and Regulatory information Proprietary Name: TRUST Common Name: Dental Abutment Design Software For Dental Laboratory Device Class: Class II Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Product Code: PNP

Indication for use: TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

05. Predicate Device Identification

Predicate device 510(k) Number: K200100 Device Name: Abutment Design Manufacturer: 3Shape A/S

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06. Device Description

TRUST has no patient contact being a software only device. (stand-alone software)

Scientific Concept

The underlying scientific concept of TRUST is to apply digital imaging tools for computer aided design(CAD) of abutments.

The system supports the following types of digital data: STL and PLY Only(3D surface data)

	Subject Device	Predicate Device	Substantial Equivalence
Device Name	TRUST	Abutment Design	-
510K number		K200100	-
Classification	Class 2	Class 2	Equivalent
Intended use	TRUST is intended asan aid to the restorationof chewing function inpartially edentulousmandibles and maxillae.TRUST is a softwaredevice intended to beused by a dentalpractitioner or dentallaboratory staff fordesigning the patientspecific component ofone-piece typeabutment. The designresult is intended to beused by themanufacturer of an	Abutment Design isintended as an aid to therestoration of chewingfunction in partially orfully edentulousmandibles and maxillae.Abutment Design isintended for use by adental practitioner ordental laboratory staff fordesigning the patientspecific component of atwo-piece, one-piece, orhybrid dental implantabutment. The resultingabutment design isintended to be used by	Substantially EquivalentDiscussion - Intended useof the subject device is asubset of the predicatedevice's Intended use, andthe inclusion of 'fullyedentulous' or not does notraise any questions ofsubstantial equivalence.Discussion - The change inallowable abutment typesdoes not raise anyquestions of substantialequivalence.
	endosseous dentalimplant abutment tocreate the final device.	the manufacturer of anendosseous dentalimplant abutment tocreate the final device
Hardware requirements
OS	Windows 7, 8, 10 (64-bit)	Windows 7, 8, 8.1 or 10 (64-bit)	Equivalence
RAM	16GB	8 GB	Equivalence or higher
MonitorResolution	1920X1080 pixels	1920x1080 pixels	Equivalence
Video CardMemory	DirectX 11	1GB DirectX 11	Equivalence
AvailableHDD Space	500 GB (1TB if used asa standalone system ora server with the orderfolder)	500 GB (1TB if used as astandalone system or aserver with the orderfolder)	Equivalence
CPU	Intel I3 Dual core	Intel Core i7 orequivalent	Equivalence or lower
Network	Network Internetconnection	Network Internetconnection	Equivalence
USB ports	Software only	USB 2.0 port for 3Shapedesktop scanner	Not EquivalenceNo additional connectionrequired
Mouse	With the wheel buttonsupport	With the wheel buttonsupport	Equivalence
3D Mouse	Including wheel controlmouse	(Optional) 3DConnexionSpaceMouse™ Pro	Not EquivalenceIt only supports normalkeyboards and mouse.
Feature
Graphical UI	Yes	Yes	Equivalence
Windows OSplatform	Yes	Yes	Equivalence
Usesstandard PChardware	Yes	Yes	Equivalence

Digitallyimportstopographyof teeth by3D Scan	Yes	Yes	Equivalence
Uses 3DCAD designtools	Yes	Yes	Equivalence
Patientspecificabutmentdesign	Yes	Yes	Equivalence
Implant Bardesign	No	No	Equivalence
Export toremotemillingmachine byinternet	Yes	Yes	Equivalence
NetworkProtocol	Internet/TCP-IP	Internet/TCP-IP	Equivalence
Intendedusers	Dental practitioners anddentaltechnicians	Dental practitioners anddental technicians	Equivalence
Output type	The abutment is savedas a .TMZ file. Digitalencryptedproprietary .TMZ file onlyof the patient specificabutment component,not including theabutment-to implantconnection interface.Encryption is alwaysactive until the output isdecrypted by our serversduring the orderingprocess, when it is sentto an abutmentmanufacturer forcreation of the final	Digital encrypted or non-encrypted proprietaryor .STL file only of thepatient specific abutmentcomponent, not includingthe abutment-to implantconnection interface. Ifencryption is active or notwill solely be determinedby the 510(k) clearanceof the abutment system.	Equivalence
	device.
*Devicesubmissionincludes pre-manufacturedprosthetics	No	No	Equivalence

07. Summary of Technological Characteristics Comparison

TRUST has the same intended uses, principle of operation and similar technical characteristics and

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Abutment Design (K200100) is bundled with Intra-oral Scanner or model scanner. Trust is stand-alone and Web distribution S/W. Abutment Design(K200100) manages licenses in a USB dongle, while Trust manages licenses in the web.

The difference in use of a USB dongle compared to the subject license management in the web is addressed by cybersecurity measures which use the IP address to verify user's ID and password.

08. Non clinical Testing Data

Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005.

The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.

The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014.

All test results have been reviewed and approved, showing the TRUST to be substantially equivalent to the primary predicate device.

09. Clinical Testing

Clinical testing is not a requirement and has not been performed.

10. Substantial Equivalence Conclusion

Based on the results of software validation and the information provided herein, we conclude that the proposed device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)