Metacem is a high strength, permanent visible light cured (VLC), dual cured or self-cured resin cement for use with dentin/enamel adhesive prime and bone systems, to adhesively bond and lute indirect restorations to tooth structure. Metacem consists of a methacrylate base paste and catalyst paste which in use are instantly mixed from a dual syringe of form a dual-cured cement. This mixed version of the cement will self-cure or can be light cured, or both. The dual cure is effective for dark shade, thick or opaque cementation.

AI/ML Overview

The provided document is a 510(k) Summary for a dental cement called Metacem. It aims to demonstrate substantial equivalence to a predicate device, also named Metacem (K081913). The document focuses on regulatory approval rather than providing a detailed study report with acceptance criteria for an AI/ML device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving a device meets acceptance criteria (in the context of an AI/ML device) cannot be fully provided based on the given text.

The document describes performance tests for a dental cement, not an AI/ML device. The "acceptance criteria" discussed are primarily based on relevant ISO standards for dental materials.

However, I can extract the relevant performance data and address the components of your request that are applicable to this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a dental cement, acceptance criteria are typically defined by international standards like ISO 4049 and ISO 11405. The document presents the performance of the subject device (Metacem, K171449) against these standards and compares it to a predicate device (Metacem, K081913).

Acceptance Criteria (Standard Reference)	Predicate Device Performance (K081913)	Subject Device Performance (K171449)	Met Acceptance Criteria (Yes/No)
Film thickness (ISO 4049:2009)	0.034 ± 0.006 mm (34 µm)	26.4 µm	Yes (Lower is generally better for film thickness)
Working time (ISO 4049:2009)	2 min 32 sec	Homogeneous (No specific time given, but implies consistent working properties similar to predicate)	Implied Yes (similar to predicate)
Setting time (ISO 4049:2009)	5 min 17 sec	A1: 3min 14sec, A3: 3min 04sec, B2: 3min 57sec, OP: 3min 34sec, TL: 2min 28sec	Yes (Within expected ranges for dental cements, variations expected for different shades)
Flexural strength (ISO 4049:2009)	99 ± 16.1 MPa	120.5 MPa	Yes (Subject device shows higher flexural strength, which is favorable)
Water sorption (ISO 4049:2009)	29.31 ± 6.81 µm/mm³	14.0 µg/mm³	Yes (Lower water sorption is favorable)
Solubility (ISO 4049:2009)	2.33 ± 1.30 µm/mm³	0.5 µg/mm³	Yes (Lower solubility is favorable)
Radio-opacity (ISO 4049:2009)	2.33 ± 0.34 mm	2.3 mm	Yes (Comparable to predicate)
Color/Color stability (ISO 4049:2009)	Consistency	Consistency	Yes (Implied similar to predicate)
Tensile Bond Strength - Enamel (ISO 11405)	28.3 MPa	27.5 MPa	Yes (Comparable to predicate)
Tensile Bond Strength - Dentin (ISO 11405)	7.6 MPa	6.1 MPa	Yes (Comparable to predicate - though slightly lower, FDA deemed it substantially equivalent)
Shear Bond Strength - Dentin (ISO29022:2013)	N/A	3MPa	N/A (Predicate data not available in this table)
Shear Bond Strength - Enamel (ISO29022:2013)	N/A	15MPa	N/A (Predicate data not available in this table)
Biocompatibility (ISO 10993 series)	Not explicitly listed, but implied through prior approval	Tested according to ISO 10993-1, -5, -10, -11	Yes
Shelf life	2 years	2 years	Yes

Note: For some metrics, the wording implies "meets" by being substantially equivalent or demonstrating favorable characteristics compared to the predicate device, or by complying with the specified ISO standard.

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

Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., how many specimens for flexural strength, etc.). It only lists the tests performed according to ISO standards.
Data Provenance: The tests were conducted by Meta Biomed Co., Ltd. (South Korea) for their product Metacem. The data is retrospective in the sense that it's reported from completed tests for the 510(k) submission.

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

This question is not applicable to this document. The "ground truth" for a dental cement's performance is established through standardized physical and chemical property testing (e.g., ISO standards), not through expert clinical consensus or interpretation of images. There are no "experts" in the context of interpreting data for ground truth in this type of submission.

4. Adjudication method for the test set

This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data, which is not relevant for the physical and chemical testing of a dental cement.

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

This question is not applicable to this document. This is a submission for a dental cement, not an AI/ML device. Therefore, no MRMC study involving human readers or AI assistance would have been performed.

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

This question is not applicable to this document. This is a submission for a dental cement, not an AI/ML device.

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

The "ground truth" for the performance of this dental cement is established by objective measurements against internationally recognized standards (e.g., ISO 4049, ISO 11405, ISO 10993). For example:

Flexural strength is measured by breaking specimens and recording the force.
Water sorption is measured by changes in specimen weight after immersion.
Biocompatibility is assessed through specific in-vitro and in-vivo tests outlined in the ISO 10993 series.

8. The sample size for the training set

This question is not applicable to this document. This is a submission for a dental cement, not an AI/ML device. There is no concept of a "training set" for such a product.

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

This question is not applicable to this document. As there is no AI/ML component, there is no training set or ground truth established for it.

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 and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Meta Biomed Co., Ltd % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K171449

Trade/Device Name: Metacem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: February 7, 2018 Received: February 14, 2018

Dear April 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. 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

May 15, 2018

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K171449

Device Name Metacem

Indications for Use (Describe) Adhesive cementation of:

· Crown & Bridges (Ceramic, Composite, Porcelain, Metal)
· Inlay / Onlay cementation
· Bonding for porcelain veneers
· Endodontic posts cementation
· Core build up

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

Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ybkyb12@gmail.com Phone: +82-43-230-8959 Fax: +82-43-218-1988

Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Metacem
Classification Name: cement, dental
Product Code: EMA ●
Panel: Dental
Regulation Number: 21 CFR 872.3275
Device Class: Class II ●
Date prepared: 05/08/2018 ●

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

K081913, Metacem manufactured by Meta Biomed Co., Ltd. ●

General Description

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Indication for Use

Adhesive cementation of:

Crown & Bridges (Ceramic, Composite, Porcelain, Metal) ●
Inlay / Onlay cementation .
Bonding for porcelain veneers ●
Endodontic posts cementation ●
Core build up ●

Comparison of technological Characteristics with Predicate Devices:

	Specification	Subject Device	Primary Predicate Device
Manufacturer	-	META BIOMED CO., LTD.	META BIOMED CO., LTD.
Device Name	-	Metacem	Metacem
510(k) Number	-	NA	K081913
Classification Name	-	Dental Cement	Dental Cement
Product Code	-	EMA	EMA
Regulation Number	-	21 CFR 872.3275	21 CFR 872.3275
Indications for Use	-	Adhesive cementation of:Crown & Bridges (Ceramic, Composite, Porcelain, Metal) Inlay / Onlay cementation Bonding for porcelain veneers Endodontic posts cementation Core build up
Intended Use	-	Metacem is intended for use in the cementing or fixation of restorations and appliances such as inlays, onlays, veneers, crowns, bridges and posts classed by Type 2, Class 3 according to ISO 4049.
General Composition	-	Bis-GMA [Bisphenol A Glycerolate (1glycerol/Phenol)dimethacrylate] TEGDMA [Tri(ethylene glycol)dimethacrylate] Camphorquinone DEPT [2,2'-(P-Tolyimino)diethanol]
Film thickness	ISO 4049:2009	26.4 $μ$ m	0.034 ± 0.006 mm(34 $μ$ m)

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Working time	ISO 4049:2009	homogeneous	2 min 32 sec
Setting time	ISO 4049:2009	A1: 3min 14secA3: 3min 04secB2: 3min 57secOP: 3min 34secTL: 2min 28sec	5 min 17 sec
Flexular strength	ISO 4049:2009	120.5 MPa	99 ± 16.1 MPa
Water sorptionsolubility	ISO 4049:2009	Water sorption : 14.0 µg/mm³Solubility : 0.5 µg/mm³	Water sorption : 29.31 ± 6.81 µm/mm³Solubility : 2.33 ± 1.30 µm/mm³
Radio-opacity	ISO 4049:2009	2.3 mm	2.33 ± 0.34 mm
ColorColor stability	ISO 4049:2009	Consistency	Consistency
Tensile BondStrength	ISO 11405	Enamel: 27.5 MPaDentin: 6.1 MPa	Enamel: 28.3 MPaDentin: 7.6 MPa
Shear Bond Strength	ISO29022:2013	Dentine: 3MPaEnamel: 15MPa	N/A
Shelf life	-	2 years	2 years

Non-clinical Testing

The subject device was tested to evaluation its safety and effectiveness according to the following standards:

-Biocompatibility Tests according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-10:2010. ISO 10993-11:2006.
-Performance tests such as film thickness, working time, Flexular strength, water sorption/solubility, radio-opacity, and color/color stability according to ISO 4049:2009.
Shelf Life tests according to ISO4049:2009. -
Shear Bond Strength tests for dentin and enamel according to ISO 11405:2015. -

Conclusions

The subject device is similar to the predicate devices in that they are all dual-curing, radio-opaque and self-adhesive resin cements to be used for permanently cementing restorations.

The subject device and the predicate devices has substantially equivalent of indications for use, shelf life, physical and mechanical properties. As depicted above, the flexular strength between the subject device and predicate device demonstrate higher values for the subject device. This difference does not affect the substantial equivalence.

The subject device is different from the predicate devices in that it contains the same key biocompatible ingredients, but in different proportions. The biocompatibility test report supports this difference and it does not affect the substantial equivalence.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.