Metapaste calcium hydroxide with Barium Sulfate is a device consisting of a temporary root canal sealer paste contained within a plastic syringe, packaged with disposable applicator tips and a plastic ring rotator for direction control of the tip. It is a device intended for use by qualified healthcare personnel trained in its use.

The Metapaste device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

AI/ML Overview

The provided document is a 510(k) summary for a dental device (Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with a test set.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this document. The submission relies on a comparison of characteristics and compliance with existing standards (ISO 6876 and ISO/TR 7405) to establish equivalence.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific acceptance criteria in a quantitative table format that a study would aim to meet. Instead, it compares the "Physical Properties" and "Biocompatibility" of Metapaste with its predicate devices, indicating that Metapaste meets the standards required of such devices. The "performance" is implicitly stated as being equivalent to the predicate devices and compliant with the listed ISO standards.

Characteristic	Acceptance Criteria (Implied by Standards & Predicate)	Metapaste Reported Performance
Physical Properties:	ISO 6876 (Fluidity, Working Time, Film Thickness, Radiopacity, Solubility & Disintegration)	Complies with ISO 6876 for Fluidity, Working Time, Film Thickness, Radiopacity, Solubility & disintegration
Biocompatibility:	ISO/TR 7405 Agar diffusion test (Freedom from toxicity), ISO 10993-11 Acute intervenous application (Biocompatible)	Freedom from toxicity per ISO/TR 7405 Agar diffusion test. Biocompatible per ISO 10993-11 Acute intervenous application.
Labelling:	Temporary root canal sealer	Temporary root canal sealer
Intended Use:	Similar to predicate	Similar to predicate
Human Factors:	Dispensed ready to use	Dispensed ready to use
Design, Construction, Components:	Premixed paste, packaged in plastic syringe, disposable tips	Premixed paste, packaged in plastic syringe, disposable tips

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

Sample Size: Not specified. The document refers to compliance with ISO standards, which would involve testing, but the sample sizes for these tests are not provided in this summary.
Data Provenance: Not specified, but implied to be from laboratory testing conforming to ISO standards. The country of origin of the data is not mentioned. The studies would be considered prospective in the context of validating performance against standards.

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

This information is not applicable and not provided. The "ground truth" here is compliance with established international standards (ISO). The standards themselves are developed by expert consensus in their respective fields, but there's no mention of specific experts establishing ground truth for Metapaste's individual tests.

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

Not applicable and not provided. This type of adjudication is typically for image-based or clinical diagnostic studies, not for material property testing or biocompatibility assessments against defined standards.

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 is a material science and biocompatibility assessment, not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" used is adherence to international standards for dental materials (ISO 6876) and biocompatibility (ISO/TR 7405, ISO 10993-11). These standards define acceptable ranges for physical properties and methods for assessing safety.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, as there is no training set.

Summary

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K032605

OCT - 8 2003

1	510(k) Summary
1.1	Date of Summary Preparation:	June 26, 2003
1.2	Submitter/Contact Person:	Jenny Sohn, Official Correspondent
		TEL (718)-639-7460FAX (718)-639-7408Meta Dental Co.41-19, 77 th StreetElmhurst, NY 11373
1.3	Trade Name/Common Name:	Metapaste Calcium Hydroxide with BariumSulfate Temporary Root Canal Filling
1.4	Common Name:	Temporary Root Canal Sealer

Classification Name, Product Code, Class, Classification Reference: 1.5

Classification Name	Product Code	Class	21CFR §
Root Canal Filling Resin	KIF	II	872.3820

Standards/Special Controls: 1.6

ISO 6876 Dental root canal sealing materials.

Indications for Use: 1.7

Metapaste is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth.

Metapaste is intended for use by qualified healthcare personnel trained in its use.

1.8 Device Description:

The Metapaste device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

Substantially Equivalent Commercially Available Devices: 1.9

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The Metapaste device is substantially equivalent to the predicate device described hercin with respect to indications for use, device design, materials, and method of manufacture:

Pulpdent Calcium Hydroxide Preparation - K022734

Pulpdent Calcium Hydroxide Preparations -- K944945 (Device Listing: Tempcanal-Temporary Calcium Hydroxide Root Canal Treatment 21 CFR § 872.3250)

The predicate devices are commercially available and a marketed Class II device indicated for use as a temporary root canal sealer.

1.10 Substantial Equivalence Comparison:

Metapaste is similar to commercially available device with respect to intended use, material, design and operational principles as follows:

	Metapaste	Pulpdent Calcium	Pulpdent Calcium
		Hydroxide Preparation	Hydroxide Preparation
		(Tempcanal K944945)	(K022734)
Labelling	Temporary root canalsealer	Temporary root canal sealer	Temporary or permanent rootcanal sealer
Intended Use	Metapaste is abiocompatible rootcanal sealer used for thetemporary filling ofroot canals afterendodontic surgery.Metapaste can be usedon its own and for vitalpulpdectomics indecidious teeth.Metapaste is intendedfor use by qualifiedhealthcare personneltrained in its use.	A calcium hydroxide cavityliner material intended to beapplied to the interior of aprepared cavity beforeinsertion of restorativematerial, such as amalgam, 10protect the pulp of a tooth.	A biocompatiblepolydimethylsiloxane basedroot canal sealer used for thetemporary and permanentfilling of root canals afterendodontic surgery. Can beused on its own, inconjunction with Gutta Perchaand for vital pulpdectomies indeciduous tecth.
HumanFactors	Dispensed ready to use	Dispensed ready to use	Dispensed ready to use
Similar	ISO 6876 Fluidity.	ISO 6876 Fluidity, Working	ISO 6876 Fluidity, Working
Physical	Working Time, Film	Time, Film Thickness,	Time, Film Thickness,
Properties	Thickness, Radiopacity,Solubility &	Radiopacity, Solubility &disintegration	Radiopacity, Solubility &disintegration
	disintegration
Biocompatibility	Freedom from toxicityper ISO/TR 7405 Agardiffusion test	Freedom from toxicity perISO/TR 7405 Agar diffusionાટડા	Biocompatible
	Biocompatible per ISO10993-11 Acuteintervenous application	Biocompatible per ISO 10993-11 Acute intervenousapplication

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	Metapaste	Pulpdent CalciumHydroxide Preparation(Tempcanal K944945)	Pulpdent CalciumHydroxide Preparation(K022734)
Design,Construction,Components	Premixed paste,packaged in plasticsyringe ready to bedispensed throughdisposable tips into rootcanal	Premixed paste, packaged inplastic syringe ready to bedispensed through disposabletips into root canal	Premixed paste, packaged inplastic syringe ready to bedispensed through disposabletips into root canal

1.11 Indications and Contraindications:

Relative indications and contraindications for Metapaste and commercially available devices for similar intended uses are the same.

1.12 Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Meta Biomed Co., Ltd concludes that the new device, Metapaste root canal sealer, is safe, effective and substantially equivalent to the predicate device as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 2003

Meta Biomed Company Limited Institute C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K032605

Trade/Device Name: Metapaste Calcium Hydroxide with Barium Sulfate Root Canal Filling Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: September 22, 2003 Received: September 23, 2003

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Devine

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clues

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 032605

Indications for Use

Page 1_of_1

510(k) Number:

Device Name : Metapaste Calcium Hydroxide with Barium Sulfate Root Canal Filling

Indications for Use:

For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth.

Metapaste is intended for use by qualified healthcare personnel trained in its use.

Susan Runno

510(k) Number:

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use

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.