TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutta- percha.

Device Description

TRC-Paste is an immediately available pre-mixed root canal filling material based on Calcium hydroxide and Polypropylene Glycol 2000. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or infected root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.

AI/ML Overview

The provided text describes a 510(k) summary for the device TRC-Paste, a temporary root canal filling material. It outlines non-clinical performance data and states that the device is substantially equivalent to a predicate device. However, the document does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, the performance data presented is for a traditional medical device (a paste) and focuses on compliance with established ISO and ASTM standards for material properties and biocompatibility.

Here's an analysis of the provided information, framed to address your request, with a clear indication of what is missing based on the typical requirements for AI/ML device studies:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Based on Referenced Standards)	Reported Device Performance
ISO 6876:	All test results met the preset test criteria.
- Radiopacity	Met criteria.
- Flowability	Met criteria.
ISO 10993-5: Cytotoxicity	All test results met the preset test criteria.
- Biocompatibility (Cytotoxicity)	Met criteria.
ISO 10993-6: Implantation	All test results met the preset test criteria.
- Biocompatibility (Implantation)	Met criteria.
ISO 10993-11: Short-term systemic toxicity (Oral)	All test results met the preset test criteria.
- Biocompatibility (Systemic Toxicity)	Met criteria.
ASTM F1980-07: Shelf life test	All test results met the preset test criteria.
- Shelf life	Met criteria.
Other Bench Testing:	All test results met the preset test criteria.
- Appearance	Met criteria.
- Volume	Met criteria.
- Packaging	Met criteria.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical bench tests performed by KM Corporation. The 510(k) summary states, "All the test results met the preset test criteria." This implies that for each listed standard (ISO 6876, ISO 10993-5, ISO 10993-6, ISO 10993-11, ASTM F1980-07) and other bench tests, the TRC-Paste exhibited properties within the acceptable limits defined by those standards.

Regarding the AI/ML specific information requested, the provided document does NOT contain this information because the device is a material, not an AI/ML algorithm. Therefore, the following points are largely not applicable or missing from this specific submission:

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

Not Applicable / Missing: This information is not relevant for a physical material product. The "test set" here refers to samples of the TRC-Paste material, implicitly tested in a lab setting. No specific sample sizes for these bench tests are provided 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 / Missing: This is not relevant. Ground truth for material properties is established by objective measurements against recognized standards, not by expert consensus in the diagnostic sense.

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

Not Applicable / Missing: This refers to expert adjudication for clinical or imaging data, which is not part of this device's evaluation.

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 / Missing: This is for AI/ML diagnostic aids, not a root canal filling material.

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

Not Applicable / Missing: This is for AI/ML algorithms.

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

Type of Ground Truth (for a material): The "ground truth" for this device's performance is objective measurement against the limits and specifications defined by the referenced international standards (ISO, ASTM) for properties like radiopacity, flowability, cytotoxicity, implantation response, systemic toxicity, and shelf life.

8. The sample size for the training set

Not Applicable / Missing: This is for AI/ML models.

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

Not Applicable / Missing: This is for AI/ML models.

In summary, the provided document details the non-clinical performance data for a temporary root canal filling material, showing its compliance with various ISO and ASTM standards to demonstrate substantial equivalence. It does not involve AI/ML technology, so many of the requested data points (related to algorithms, readers, ground truth establishment for diagnostic tasks, etc.) are not present in this type of submission.

Summary

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510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 04/09/2014

1. Applicant / Submitter:

KM Corporation 727 , Seoun-ro, Miyang-myeon, Anseong-si, Gyeonggi-do, 456-843, Republic of Korea

Tel: +82-31-678-3451 Fax: +82-31-678-3489

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 9283 1 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:	TRC-Paste
Common Name:	Temporary Root Canal Filling Material
Classification Name:	Root Canal Filling Resin
Classification:	Class II, 21 CFR 872.3820
Classification Product Code:	KIF

4. Predicate Device:

Metapex by Meta Dental Co. (K032603)

5. Device Description:

TRC-Paste is an immediately available pre-mixed root canal filling material based on Calcium hydroxide and Polypropylene Glycol 2000.

This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or infected root canal therapies, it can be

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used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.

6. Intended Use:

7. Performance Data(Non-Clinical):

The following properties were tested based on the referenced standards. All the test results met the preset test criteria.

= ISO 6876 - Radiopacity, Flowability
ISO 10993-5 Cytotoxicity
- ISO 10993-6 Implantation
· ISO 10993-11 Short-term systemic toxicity(Oral)
· ASTM F1980-07 Shelf life test
· Other bench testing Appearance, volume, and packaging tests

8. Substantial Equivalence

The TRC-paste is substantially equivalent to the predicate device described herein with respect to intended use, device design, main raw material, accessory components, and delivery method.

The difference is the compositions of some additives: however, the biocompatibility and the performance testing results show that this difference does not raise issues in safety and effectiveness.

9. Conclusion:

Based on the testing results, KM Corporation concludes that the TRC-Paste is substantially equivalent to predicate device.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 9, 2014

KM Corporation C/O Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue. Suite 110 Fullerton. CA 92833

Re: K133716

Trade/Device Name: TRC-Paste Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: January 13, 2014 Received: January 15, 2014

Dear Ms. 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.

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Page 2 - Ms. Chung

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner - S

Erin I. Keith, M.S. Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page,

510(k) Number (if known) K133716

Device Name TRC-Paste

Indications for Use (Describe)

TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutts.

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

Prescription Use (Parl 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Image /page/4/Figure/11 description: This image shows a document with the heading "FOR FDA USE ONLY". It indicates the concurrence of the Center for Devices and Radiological Health (CDRH). The document includes a signature, identified as "Sheena A. Green-S", and a date and time stamp of "2014.04.09 11:03:10 -04'00'". The form number "FORM FDA 3881 (9/13)" and page number "Page 1" are also visible.

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.