The provided text is an FDA 510(k) summary for a dental device called "Diapaste." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the information provided does not contain any data or discussion regarding the acceptance criteria and study proving a device meets performance criteria related to AI/ML or human-in-the-loop performance, as implied by the original question's structure. The document is a regulatory submission for a dental material (root canal filling resin), not an AI/ML powered medical device.

Therefore, I cannot extract the requested information (table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) because it is not present in the provided text.

The closest relevant sections in the document are about non-clinical performance data for the dental material itself, which are physical properties and biocompatibility tests, not AI/ML performance.

Here's an analysis of what is present in the document regarding performance:

1. A table of acceptance criteria and the reported device performance (for physical properties, not AI/ML):

Test	Requirement (Acceptance Criteria)	Result (Reported Device Performance)
Flowability	Each disc to have a diameter of not less than 17mm	21mm (mean value)
Film thickness	No more than 50µm	45µm (mean value)
Radiopacity	Equivalent to not less than 3mm of Aluminum	Not less than 3mm of Aluminum (approx. 5.3mm)

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

The document does not specify sample sizes for these performance tests.
Data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These are typical lab tests for material properties.

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

Not applicable. These are physical property measurements, not data requiring expert interpretation or ground truth establishment in the context of diagnostic AI.

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

Not applicable for physical property measurements.

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:

Not applicable. This device is a dental material, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm.

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

For physical properties, the "ground truth" is established by direct measurement against a standard (ISO 6876).
For biocompatibility, the "ground truth" is established by laboratory tests against ISO standards (ISO 7405, ISO 10993 series).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

In summary, the provided document does not contain the information requested about AI/ML device performance. It is a regulatory clearance for a traditional medical device (a dental filling material), primarily demonstrating substantial equivalence through comparison of indications for use, composition, and conformance to relevant material-specific performance and biocompatibility standards.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 27, 2020

Diadent Group International Kab Sun, Lee Quality Assurance Manager 16. Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, 28161 KOREA

Re: K190091

Trade/Device Name: Diapaste Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: February 19, 2020 Received: February 20, 2020

Dear Kab Sun, 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 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

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

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 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).

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 Quality Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190091

Device Name DIAPASTE

Indications for Use (Describe)

Aqueous ointment material that temporarily fills the root canal for the following indications:

Apexification
Temporary root filling
Root canal filling for primary teeth
Vital pulpotomy
Temporary pulp capping

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)

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

K190091 Diadent Group International

510(k) Summary

1 Application Information

Date Prepared:	March 26, 2020
Company Name andAddress:	DiaDent Group International
	16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea
Contact Person:	Kab Sun, Lee
	Quality Assurance Manager
	Phone: +82-43-266-2315
	FAX: +82-43-235-2315
	Email: diadent32@diadent.co.kr

2 Device Information

Device Type:	Root Canal Filling Resin
Regulation Description:	Root Canal Filling Resin
Review Panel:	Dental
Regulation Number:	21 CFR 872.3820
Product Code:	KIF
Device Class:	II
Device Name:	DIAPASTE

3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

	Primary Predicate Device	Reference Predicate Device
510(k) Number:	K032605	K060365
Applicant:	Meta Biomed Co., Ltd.	Ivoclar Vivadent
Device Name:	Metapaste	ApexCal
Regulation Number:	21 CFR 872.3820	21 CFR 872.3250
Product Code:	KIF	EJK
Device Class:	II	II

4 Device Configuration

Each model configurations of subject device are described as following:

Model Name	Contents
DiaPaste Type A	1 syringe(2g), 20 disposable tips, 1 silicone cap
DiaPaste Type B	1 syringe(2g), 10 disposable tips, 1 silicone cap
DiaPaste Type C	1 syringe(2g), 4 disposable tips, 1 silicone cap
DiaPaste Refill Kit	1 syringe(2g)
DiaPaste Intro Kit	1 syringe(0.5g), 4 disposable tips 1 silicone cap

5 Device Description

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

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

K190091

Diadent Group International

6 Intended Use/Indications for Use

Aqueous ointment material that temporarily fills the root canal for the following indications:

· Apexification
· Temporary root filling
· Root canal filling for primary teeth
· Vital pulpotomy
· Temporary pulp capping

7 Comparison Table and Discussion

This device compares to the legally marketed devices as follows:

	Subject Device	Primary PredicateDevice	Reference PredicateDevice
	DiaPaste	Metapaste	ApexCal	Discussion
RegulationNumber:	21 CFR 872.3820	21 CFR 872.3820	21 CFR 872.3250
510(k)Number	K190091	K032605	K060365	-
Indicationfor Use	Aqueous ointmentmaterial thattemporarily fills theroot canal for thefollowingindications:- Apexification- Temporary root filling- Root canal filling forprimary teeth- Vital pulpotomy- Temporary pulpcapping	Metapaste is abiocompatible root canalsealer used for thetemporary filling of rootcanals after endodonticsurgery. Metapaste can beused on its own and forvital pulpectomies indecidious teeth.Metapaste is intended foruse by qualified healthcarepersonnel trained in itsuse.	ApexCAL is a CalciumHydroxide paste that has acreamy consistency and issuitable for severalindications including:* Temporary disinfectantdressings in the obturationof root canals;* Indirect pulp capping ormanagement of deepcaries lesions; or* Direct pulp capping.
Composition	- Calcium hydroxide- Calcium carbonate- Zinc oxide- Barium sulfate- Water- Polyethylene glycol400- Polysorbate(Tween80)	Calcium HydroxideBarium SulfatePoly propylene glycol	- Calcium hydroxide- Bismuth carbonate- Zinc oxide- Polyethylene glycol- glycerin- Water
Period ofUse	Temporary(remains in the body for29 days or less)	Temporary	Temporary	equivalent
Physicalproperties	Conformed to ISO 6876- Flowability- Film Thickness- Radio-opacity	Conformed to ISO 6876		equivalent
Biocompatibility	Biocompatible- Cytotoxicity- Sensitization- Acute Systemic toxicity- Oral Mucosa irritation- Genetoxicity-Bacterial ReverseMutation- Genetoxicity-Micronucleustest	BiocompatibleFreedom from toxicity perISO/TR 7405 Agardiffusion test	Biocompatible	equivalent
PackageContents	• Syringe• Disposable Tip• Silicone Cap	• 2.2g paste in a syringe• Disposable tips• One ring rotator for thedirection control of the tip	• 2 syringes 2.5g each• 15 application tips	-

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

K190091

Diadent Group International

Differences

- Indication For Use

DiaPaste(K190091)	Primary Predicate Device(Metapaste, K032605)	Discussion
Aqueous ointment materialthat temporarily fills the rootcanal for the followingindications:· Apexification· Temporary root filling· Root canal filling forprimary teeth· Vital pulpotomy· Temporary pulp capping	Metapaste is abiocompatible root canalsealer used for thetemporary filling of rootcanals after endodonticsurgery.Metapaste can be used onits own and for vitalpulpectomies in decidiousteeth.Metapaste is intended foruse by qualified healthcarepersonnel trained in its use.	Diapaste and Primary predicate device(Metapaste) can be used for apexification &pulpectomy technique for root canaltreatment as temporary root canal fillingmaterials. The Indication for Use of Subjectand predicate devices has same contents.In the DiaPaste's Indication for Use, there arecontents of Pulpotomy and Temporary pulpcapping that is not found in Indication of useof Metapaste. It is a technique commonlyused of temporary root canal fillings and assuch does not affect the equivalence ofIndication of subject and predicate devices.

-Composition

Subject Device	Primary Predicate Device(K032605)	Reference PredicateDevice(K060365)	Discussion
- Calcium hydroxide- Calcium carbonate- Zinc oxide- Barium sulfate(Radiopaque)- Water- Polyethylene glycol 400- Polysorbate (Tween80)	Calcium HydroxideBarium Sulfate(Radiopaque)Poly propylene glycol	- Calcium hydroxide- Bismuth carbonate- Zinc oxide- Polyethylene glycol- glycerin- Water	The main ingredient ofsubject and predicatedevices is CalciumHydroxide. and thefunctions of otheradditives are similar(base, Radiopaque,pH controller,Stabilizer).Also, thebiocompatibility ofsubject device wasconfirmed bybiological safety study.

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

Diadent Group International

8. Non-Clinical performance data

This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:

-ISO 6876	Root Canal Sealing materials
-ISO 7405	Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
-ISO 10993-1	Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
-ISO 10993-3	Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-ISO 10993-5	Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity
-ISO 10993-10	Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-ISO 10993-11	-ISO 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity

The following Performance tests were conducted.

-Flowability
-Film thickness
-Radiopacity
-Biocompatibility test

Performance test (Physical properties):

Test	Requirement	Result	Pass/Fail
Flowability	Each disc to have a diameter of notless than 17mm	21mm (mean value)	Pass
Film thickness	No more than 50µm	45µm (mean value)	Pass
Radiopacity	Equivalent to not less than 3mm ofAluminum	Not less than 3mm ofAluminum (approx. 5.3mm)	Pass

9. Conclusion

Based on the above information and all data provided in this submission, including comparison of intended uses, technological characteristics discussion of differences of subject and predicate devices, show that the subject device and the predicate device have similar technical characteristic and chemical composition.

It is demonstrated that the subject device and the legally marketed devices identified in this submission are substantially equivalent.

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.