The provided text describes the regulatory clearance of a root canal filling resin, Well-Root™ ST, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, clinical outcomes, or human-in-the-loop performance, as implied by the request. Instead, the "performance data" section refers to bench testing against ISO standards and biocompatibility tests. These are typically used to demonstrate the physical, chemical, and biological safety of a material, not to evaluate the diagnostic or clinical efficacy of an AI-powered medical device.

Therefore, many of the requested items, particularly those related to diagnostic accuracy, a test set, ground truth, experts, and comparative effectiveness studies, cannot be answered from the provided text.

Here's an attempt to answer the questions based only on the information available in the provided text, highlighting where the information is not present or not applicable to the context of AI device studies:

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

The document lists performance standards it conformed to (ISO 6876 and ISO 10993 series), and mentions that "the test result of the subject device satisfies the requirement of the ISO 6876" and "the results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness." However, specific numerical acceptance criteria and reported performance values for these tests are not detailed in the provided text.

The document mentions compliance with the following ISO standards and specific tests within them:

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 6876: Flow	Satisfies requirements
ISO 6876: Setting Time	Satisfies requirements
ISO 6876: Film Thickness	Satisfies requirements
ISO 6876: Solubility and disintegration	Satisfies requirements
ISO 6876: Radio-opacity	Satisfies requirements
ISO 6876: Working time	Satisfies requirements
ISO 10993-5 (Cytotoxicity)	Compliant
ISO 10993-10 (Sensitivity-LLNA, GPMT)	Compliant
ISO 10993-11 (Acute systemic Toxicity)	Compliant
ISO 10993-3 (Genotoxicity: Bacterial reverse mutation (Ames), In vitro mammalian chromosomal aberration)	Compliant
ISO 10993-6 (Implantation)	Compliant
Shelf Life: Appearance	Compliant
Shelf Life: ISO 6876 tests (Flow, Setting Time, Film Thickness)	Compliant

Note: The text explicitly states, "the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance." It also mentions for shelf life "Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)" were conducted, implying compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This document describes physical, chemical, and biocompatibility testing of a root canal filling resin, not an AI-powered diagnostic device that would typically have a "test set" of data (e.g., images, patient records). The testing methods for ISO standards usually involve a defined number of samples for each test (e.g., N=3 or N=5 for flow, setting time, etc.), but these specific numbers are not given in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth, in the context of diagnostic AI, refers to the confirmed correct diagnosis or outcome. For a physical device like a root canal sealer, "ground truth" would relate to the validated methods of the ISO standards themselves, not expert judgment on cases.

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

Not applicable/Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations (e.g., in reading medical images) for establishing ground truth, which is not the type of study described here.

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. This is not a study involving human readers or AI assistance. It is a submission for a physical medical device.

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

No. This is not an algorithm or AI device.

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

For the ISO and biocompatibility tests: The "ground truth" is established by the specified methodologies and criteria outlined within the respective ISO standards (e.g., ISO 6876 for physical properties of root canal filling materials, ISO 10993 series for biocompatibility). These standards define the acceptable range or characteristics for the device's performance.

8. The sample size for the training set

Not applicable/Not provided. As this is not an AI device, there is no "training set."

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

Not applicable/Not provided. As this is not an AI device, there is no "training set" or corresponding ground truth establishment in that context.

Summary

{0}------------------------------------------------

December 20, 2017

Vericom Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc 690 Roosevelt Irvine, California 92620

Re: K170950

Trade/Device Name: Well-Root ST Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 20, 2017 Received: November 21, 2017

Dear Priscilla Chung:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

Page 2 - Priscilla Chung

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K170950

Device Name

Well-Root™ ST

Indications for Use (Describe)

Permanent sealing of root canal

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

☑ Prescription Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
-----------------------------------------------------------	----------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary (K170950)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 12/15/2017

1. Applicant / Submitter:

Vericom Co., Ltd. 48,Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do, 200-944, Republic of Korea Tel: +82-31-441-2881 Fax: +82-31-441-2883

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Trade Name: Well-Root™ ST
Classification Name: Root Canal Filling Resin
Classification regulation: 21CFR 872.3820
Product Code: KIF

4. Predicate Device:

Primary Predicate Device: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International
. Reference Device: iRoot SP (K080917) by Innovative BioCeramix, Inc.

5. Description:

Well-Root™ ST is a convenient premixed ready-to use composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder. We offer the following three types of package configuration. The raw materials including chemical composition of the Well-Root ST Type C (E) and Well-Root ST Type F (for sample) are the same. The only difference between the types are the net weight.

{4}------------------------------------------------

Package Type Name	Package Contents
Well-Root ST Type C	2g Syringe 1ea, Disposable Tip 20ea, Holder 1ea
Well-Root ST Type E	2g Syringe 1ea, Disposable Tip 15ea, Holder 1ea
Well-Root ST Type F(for sample)	0.5g Syringe 1ea, Disposable Tip 3ea, Holder 1ea

6. Indications for use:

Permanent sealing of root canal

7. Comparison to the Cleared Device

Well-Root™ ST has the same intended use as the predicate devices: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International and iRoot SP (K080917) by Innovative BioCeramix, Inc. The indication of the statement of the subject device is more simplified than the predicate devices but it does not contain new indications.

All of the devices confirm to ISO 6876 and are provided non-sterile. Both Well-Root™ ST and the iRoot SP (K080917) premixed ready-to-use injectable white hydraulic cement paste.

The difference between the Well-Root™ ST and the primary predicate device (AH PLUS ROOT CANAL SEALER) are delivery form and setting time. However, the differences do not affect to safety and effectiveness of product considerably. Delivery forms are just one of the attributes medical devices have for convenience of use. For the setting time, the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance.

We identified the reference device (iRoot SP) for similar raw materials and delivery form premixed ready-to use injectable paste. Well-Root ST is composed of lubricants, radiopaque agent and thickening agents as the reference device. Main materials, Calcium aluminosilicate compound of Well-Root ST is similar to Calcium silicate of the reference device. Also zirconium oxide as radiopaque agent is contained in both subject device and the reference device.

The results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness. Therefore, it is concluded that Well-Root™ ST is substantially equivalent to the predicate device.

	Subject Device	Primary PredicateDevice	Reference Device
Trade Name	Well-Root™ ST	AH PLUS ROOTCANAL SEALER	iRoot SP
Manufacturer	VERICOM CO., LTD.	Dentsply International	Innovative BioCeramix,Inc.
510K Number	K170950	K960548	K080917
Product Code	KIF	KIF	KIF

Indications for Use	Permanent sealing ofroot canal	AH PLUS Root CanalSealer is used forpermanent sealing of rootcanals followingestablished endodonticprocedures.	• Permanent obturation ofthe root canal followingvital pulp-extirpation• Permanent obturation ofthe root canal followingremoval of infected ornecrotic pulp andplacement of intracanaldressings.iRoot SP is suitable for usein the single cone andlateral condensationtechnique.
	Insoluble, radiopaquematerial based on acalcium aluminosilicatecompound containing:	Epoxy resin paste(PasteA) and the amine-containing paste(Paste B)containing:	Insoluble, radiopaquematerial based on acalcium silicate compoundcontaining:
Raw materials	LubricantsZirconium oxideCalcium sulfatedihydrateTitanium dioxideInorganic glass(Calciumsodium phosphosilicate)	Paste ABisphenol-A epoxy resinBisphenol-F epoxy resinCalcium tungstateZirconium oxideSilicaIron oxide pigments	Thickening agentZirconium oxideFiller
	Calcium aluminosilicatecompound	Paste BDibenzyldiamineAminoadamantaneTricyclodecane-diamineCalcium tungstateZirconium oxideSilicaSilicone oil	Calcium phosphatemonobasicCalcium hydroxideCalciumsilicates(Tricalciumsilicate, Dicalciumsilicate)
Principle of operation	Well-Root™ ST is aconvenient premixedready-to-use injectablewhite hydraulic cementpaste developed forpermanent root canalfilling and sealingapplications. Well-Root™ ST is aninsoluble, radiopaquematerial which sets andhardens with moistureproviding from dentintubules during hydrationreaction. Well-Root™ST is packaged in a pre-loaded syringe and issupplied with disposabletips.	AH Plus Root CanalSealer consists of twocomponents, the epoxyresin paste(Paste A) andthe amine-containingpaste(Paste B) portionswhich are mixed prior toinsertion into the rootcanal.AH Plus Root CanalSealer is two-componentsystems that react via anepoxide/amine chemicalreaction to cause setting.	iRoot SP is a convenientpremixed ready-to-useinjectable white hydrauliccement paste developedfor permanent root canalfilling and sealingapplications. iRoot SP isan insoluble, radiopaquematerial which requiresthe presence of water toset and harden. iRoot SP ispackaged in a pre-loadedsyringe and is suppliedwith disposable tips.
PerformanceStandardConformance	Conformed to ISO 6876	Conformed to ISO 6876	Conformed to ISO 6876
Biocompatibility	Yes	Yes	Yes
Use	Prescription / Hospital	Prescription / Hospital	Prescription / Hospital
Delivery Forms	Single paste	Manual mixing of pasteA and paste B	Single paste
Sterility	Non-sterile	Non-sterile	Non-sterile

{5}------------------------------------------------

{6}------------------------------------------------

8. Performance Data

The following testing was conducted on our subject device:

. Shelf Life: Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)
ISO 6876: Flow, Film Thickness, Solubility and disintegration, Radio-opacity, Working time
ISO 10993-5 (Cytotoxicity), 10993-10 (Sensitivity-LLNA, GPMT), 10993-11 (Acute ● systemic Totoxicity), ISO 10993-3 (Genotoxicity-Bacterial reverse mutation(Ames), In vitro mammalian chromosomal aberration), ISO10993-6 (Implantation)

The subject device is different from the predicate devices in shelf life and raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate devices.

9. Conclusion

Based on documentation supplied with this submission, conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate devices.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.