Metapex calcium hydroxide with lodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

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

Device Description

Metapex calcium hydroxide with Lodoform 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 Metapex 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 text is a 510(k) Summary for a dental device called "Metapex". This document is for a medical device seeking clearance based on substantial equivalence to a predicate device, not for a new device requiring rigorous clinical trials to prove efficacy against acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, in the typical sense of a novel device, is not explicitly present.

For 510(k) submissions, the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device by showing similar indications for use, technological characteristics (materials, design, operational principles), and performance (often through adherence to recognized standards for physical, chemical, and biological properties). The "study" isn't a prospective clinical efficacy study but rather testing to show the new device meets the same standards as the predicate.

However, I can extract the relevant information presented in the document that aligns with the spirit of your request.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically aligned with relevant international standards and direct comparisons to a predicate device. The performance is reported as meeting these standards or being similar to the predicate.

Acceptance Criteria (based on ISO 6876 & ISO/TR 7405)	Reported Device Performance (Metapex)
Physical Properties (per ISO 6876):
- Fluidity	Meets ISO 6876
- Working Time	Meets ISO 6876
- Film Thickness	Meets ISO 6876
- Radiopacity	Meets ISO 6876
- Solubility & Disintegration	Meets ISO 6876
Biocompatibility:
- Freedom from toxicity (Agar diffusion test)	Meets ISO/TR 7405 (Freedom from toxicity)
- Biocompatible (Acute intravenous application)	Meets ISO 10993-11 (Biocompatible)
Design, Construction, Components:	Premixed paste, packaged in plastic syringe ready to be dispensed
Labeling/Intended Use Equivalence	Temporary or permanent root canal sealer; similar to predicate
Human Factors	Dispensed ready to use (similar to predicate)

"Study" Proving Acceptance Criteria:

The "study" in this context is a series of tests and analyses conducted to demonstrate that the Metapex device meets the specified ISO standards for dental root canal sealing materials (ISO 6876) and biocompatibility (ISO/TR 7405 and ISO 10993-11), and that it is substantially equivalent to the predicate device (Vitapex Pre-Loaded Dental Syringe (K973667)). This is not a clinical efficacy trial, but rather a set of bench tests and a comparison of device characteristics.

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

The document does not provide specific details on the sample sizes used for each individual test (e.g., how many samples were tested for fluidity, working time, etc.). The data provenance is implied to be from laboratory testing conducted by or for the manufacturer (Meta Dental Co. / Meta Biomed Co., Ltd). The specific country of origin for the lab data is not explicitly stated, but the manufacturer is based in Elmhurst, NY, and the correspondent in South Korea (Meta Biomed Co., Ltd). This would be considered prospective laboratory testing rather than retrospective data analysis.

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)

This is not applicable. For a 510(k) submission focusing on substantial equivalence through physical and biological property testing, "ground truth" is established by adherence to recognized international standards (ISO 6876, ISO/TR 7405, ISO 10993-11) and direct comparison to a legally marketed predicate device. There is no expert consensus on the "truth" of an image or clinical outcome in this context.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in expert opinions. This 510(k) summary focuses on laboratory testing against established 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 device is a dental material, a root canal sealer, not an AI software or imaging system that would involve human readers or AI assistance.

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

Not applicable. This device is not an algorithm or AI system.

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

For this 510(k) submission, the "ground truth" for demonstrating device performance and safety is based on internationally recognized technical standards (ISO 6876 for physical properties of dental root canal sealers, and ISO/TR 7405 / ISO 10993-11 for biocompatibility). The "truth" is that the device's measured properties adhere to these standards and are similar to those of the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of device (a dental material). This term is relevant for machine learning or AI models.

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

Not applicable, as there is no training set for this device.

Summary

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OCT = 7 2003 510(k) Summary 1

Date of Summary Preparation: July 30, 2003 1.1
Jenny Sohn, Official Correspondent 1.2 Manufacturers Contact Person: TEL (718)-639-7460 FAX (718)-639-7408 Meta Dental Co. 41-19, 77th Street

Elmhurst, NY 11373

1.3 Metapex Trade Name:

Classification Name, Product Code, Class, Classification Reference: 1.4

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

1.5 Standards/Special Controls:

ISO 6876 Dental root canal sealing materials.

1.6 Indications for Use:

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

1.7 Device Description:

Metapex calcium hydroxide with lodoform 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 Metapex device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

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Substantially Equivalent Commercially Available Devices: 1.8

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

Vitapex Pre-Loaded Dental Syringe ~ (K973667)

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

1.9 Substantial Equivalence Comparison:

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

	Metapex	Vitapex Pre-Loaded DentalSyringe
Labelling	Temporary or permanent rootcanal sealer	Temporary or permanent rootcanal sealer
Intended Use	For use, as a temporary orpermanent root canal sealer, tostimulate healing process due tothe mixture of calcium hydroxideand iodoform and the inductioneffect of these two ingredients.Used to promote healing effectsand to help prevent bacterialcontamination of the canal, as thetwo ingredients improve theinduction effect for hard tissueinduction and deposition. To beused as a medicament for thetreatment of infected root canals,and as a permanent, low volumeadditive to the filling process of atreated root canal to assist in theinduction and deposition of hardtissue to make the healing processmore rapid and complete. For usein the treatment of infected rootcanals, or following pulpectomy, orfor apexegenesis or apexificaation,and/or for the tip filling of prepared,treated root canals at the time offinal filling with gutta-percha.Intended for use by qualifiedhealthcare personnel trained in itsuse.	For use, as a temporary orpermanent root canal sealer, tostimulate healing process due tothe mixture of calcium hydroxideand iodoform and the inductioneffect of these two ingredients.Used to promote healing effectsand to help prevent bacterialcontamination of the canal, as thetwo ingredients improve theinduction effect for hard tissueinduction and deposition. To beused as a medicament for thetreatment of infected root canals,and as a permanent, low volumeadditive to the filling process of atreated root canal to assist in theinduction and deposition of hardtissue to make the healingprocess more rapid and complete.For use in the treatment ofinfected root canals, or followingpuipectomy, or for apexegenesisor apexificaation, and/or for thetip filling of prepared, treated rootcanals at the time of final fillingwith gutta-percha.Intended for use by qualifiedhealthcare personnel trained in itsuse.
HumanFactors	Dispensed ready to use	Dispensed ready to use
SimilarPhysicalProperties	ISO 6876 Fluidity, Working Time,Film Thickness, Radiopacity,Solubility & disintegration	ISO 6876 Fluidity, Working Time,Film Thickness, Radiopacity,Solubility & disintegration

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	Metapex	Vitapex Pre-Loaded DentalSyringe
Biocompatibility	Freedom from toxicity per ISO/TR7405 Agar diffusion test	Freedom from toxicity per ISO/TR7405 Agar diffusion test
	Biocompatible per ISO 10993-11Acute intervenous application	Biocompatible per ISO 10993-11Acute intervenous application
Design,Construction,Components	Premixed paste, packaged inplastic syringe ready to bedispensed through disposable tipsinto root canal	Premixed paste, packaged inplastic syringe ready to bedispensed through disposable tipsinto root canal

1.10 Indications and Contraindications:

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

1.11 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, Metapex 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 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: K032603

Trade/Device Name: Metapex Calcium Hydroxide with Lodoform 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 (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.

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 vour device to proceed to the market.

If you 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, >

Quls

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

Enclosure

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032603

Indications for Use

Page 1 of

510(k) Number:

Metapex Calcium Hydroxide with lodoform Root Canal Filling Device Name :

Indications for Use:

Metapex calcium hydroxide with lodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexedenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with qutta-percha.

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

Suer Rump

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

510(k) Number:

(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) OR

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.