iRoot BP Injectable Root Canal Repair Filling Material (iRoot BP) is a convenient ready-to-use white hydraulic premixed injectable BioAggregate paste developed for permanent root canal repair and filling applications. iRoot BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP is packaged in a preloaded syringe and is supplied with disposable tips.

AI/ML Overview

The device in question, iRoot BP Injectable Root Canal Repair Filling Material, is a dental product and theprovided text describes its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific clinical acceptance criteria in the way an AI/ML device would.

Therefore, the following information is not applicable or not provided in the given text:

Acceptance criteria and reported device performance in a table (as this is not an AI/ML device with quantifiable performance metrics like accuracy, sensitivity, etc.).
Sample size for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone performance (without human-in-the-loop).
Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Instead, the documentation focuses on non-clinical tests to establish substantial equivalence.

Here's an analysis of the provided information, framed as closely as possible to your request, while acknowledging the limitations for a non-AI/ML device:

Device: iRoot BP Injectable Root Canal Repair Filling Material

1. Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices through comparable chemical, physical, and biocompatible properties, as well as similar performance specifications. The "reported device performance" are the results of these non-clinical tests compared to the established properties of the predicates.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices)	Reported Device Performance (Summary of Non-Clinical Test Results)
Equivalent chemical composition to predicate devices BioAggregate, iRoot SP, Jeltrate® Plus™ Impression Material, and Clearfil™ Ceramic Primer.	iRoot BP's main chemical composition is based on BioAggregate. Additional chemical components are found in iRoot SP, Jeltrate® Plus™ Impression Material, and Clearfil™ Ceramic Primer, which are deemed safe and effective.
Comparable physical properties to BioAggregate (flow, working time, setting time, dimensional change following setting, solubility, radiopacity).	Bench tests for iRoot BP included flow, working time, setting time, dimensional change following setting, solubility, and radiopacity, and demonstrated comparability to BioAggregate and iRoot SP.
Comparable biocompatibility properties (non-cytotoxic, non-mutagenic, no allergenic potential, good tolerance by subcutaneous tissue) to BioAggregate and iRoot SP.	iRoot BP was determined to be non-cytotoxic. Biocompatibility data from BioAggregate and iRoot SP (chemical components are shared) provided evidence that iRoot BP is non-mutagenic, does not cause an allergenic potential after multiple uses, and has good subcutaneous tissue tolerance.
Similar delivery system to iRoot SP.	iRoot BP has a comparable delivery system to iRoot SP (preloaded syringe with disposable tips).
Same indications for use as predicate devices.	iRoot BP has the same indications for use as specified for predicate devices (Repair of Root Perforation, Repair of Root Resorption, Root End Filling, Apexification, Pulp Capping).

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The testing described is primarily laboratory bench testing and biocompatibility assessment, not a clinical trial with a "test set" in the context of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable as the evaluation is based on non-clinical laboratory tests and established properties of predicate devices, not expert interpretation of clinical cases.

4. Adjudication Method for the Test Set

This is not applicable, as there isn't a test set requiring expert adjudication.

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 not an AI/ML system and does not involve human readers for interpretation.

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

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

7. The Type of Ground Truth Used

For physio-chemical properties and performance specifications, the "ground truth" is derived from established standards for dental materials and the known, FDA-accepted properties of the predicate devices (BioAggregate, iRoot SP, Jeltrate® Plus™ Impression Material, Clearfil™ Ceramic Primer).
For biocompatibility, the "ground truth" comes from standard biocompatibility testing protocols and the established safety profiles of the chemical components present in the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set for machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set mentioned or implied for this device.

Summary

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K082943

510(k) SUMMARY

JAN - 6 2009

1628 West 75th Avenue Vancouver, BC V6P 6G2 Canada

Tel: 604-221-6800 Fax: 604-677-6129

INNOVATIVE BIOCERAMIX INC

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92

SUBMITTER:	Innovative BioCeramix Inc.1628 West 75th AvenueVancouver, BCV6P 6G2 CanadaTel: 604-221-6800 Fax: 604-677-6129
CONTACT:	Quanzu Yang
SUMMARY PREPARED:	September 26, 2008
TRADE NAME:	iRoot BP
COMMON NAME:	Injectable Root Canal Repair Filling Material
CLASSIFICATION NAME:	Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF)
PREDICATE DEVICES:	BioAggregate (K063422) Specific chemical compositions: BioAggregate (K063422)iRoot SP (K080917)Jeltrate® Plus™ Impression Material (K952614)Clearfil™ Ceramic Primer (K061906) Delivery system: iRoot SP (K080917)
DEVICE DESCRIPTION:	iRoot BP Injectable Root Canal Repair Filling Material (iRoot BP) is a convenient ready-to-use white hydraulic premixed injectable BioAggregate paste developed for permanent root canal repair and filling applications. iRoot BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot BP does not shrink during setting and demonstrates excellent physical

INTENDED USE:

Repair of Root Perforation �
properties. iRoot BP is packaged in a preloaded syringe and is supplied with
Repair of Root Resorption .
Root End Filling
Apexification

disposable tips.

Pulp Capping

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K082943

1628 West 75th Avenue
Vancouver, BC
V6P 6G2 Canada
Tel: 604-221-6800
Fax: 604-677-6129

INNOVATIVE BIOCERAMIX INC.

TECHNOLOGICAL CHARACTERISTICS:

iRoot BP and BioAggregate are designated for the equivalent dental applications, and have comparable chemical and physical properties, and performance specifications.

The main chemical composition of iRoot BP is based on BioAggregate. Additional predicate devices include: iRoot SP, Jeltrate® Plus™ Impression Material and Clearfil™ Ceramic Primer, each contains specific chemical components that are equivalent to those found in iRoot BP; providing evidence that these chemical components are safe and effective for medical device use. Furthermore, iRoot BP and iRoot SP have similar delivery systems.

NON-CLINICAL TESTS PERFORMED:

CONCLUSIONS:

iRoot BP has undergone extensive bench and biocompatibility testing to provide evidence that iRoot BP's chemical and physical properties are substantially equivalent to BioAggregate and iRoot SP. Bench tests included: flow, working time, setting time, dimensional change following setting, solubility, and radiopacity.

Biocompatibility test results determined that iRoot BP is non-cytotoxic. Since iRoot BP's chemical composition is based on the principal chemical components in both BioAggregate and iRoot SP, the biocompatibility test data of BioAggregate and iRoot SP provides biocompatibility evidence that iRoot BP is non-mutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.

iRoot BP has the same indications for use, provides similar chemical, physical and biocompatible properties, and demonstrates comparable performance specifications to BioAggregate. iRoot BP's main chemical composition is based on BioAggregate and the additional chemical components in iRoot BP's composition were found to be safe and effective in iRoot SP, Jeltrate® Plus™ Impression Material and Clearfilm Ceramic Primer. In addition, iRoot BP has a comparable delivery system to iRoot SP. Therefore, it is concluded that iRoot BP is safe, effective and substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 2009

Mr. Quanzu Yang President/ Chief Executive Office Innovative BioCeramix, Incorporated 1628 West 75th Avenue Vancouver, BC V6P 6G2 Canada

Re: K082943

Trade/Device Name: iRoot BP Injectable Root Canal Repair Filling Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: December 12, 2008 Received: December 29, 2008

Dear Mr. Yang:

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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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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding posimarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Snyde Y. Michael Duds

Ginette Y. Michaud, MD Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

82943

510(k) Number (if Known):

Device Name:

Indications for Use:

.
.

iRoot BP Injectable Root Canal Repair Filling Material

Repair of Root Perforation
Repair of Root Resorption
Root End Filling
Apexification
Pulp Capping

l Prescription Use (Part 21 CFR 801 Subpart D)

ੱਕ

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
S Y Michun Omd

(Division Stan-Uff) Division of Anesthesiology. General Hospital Infection Control. Dental Devices

510(k) Number: K082943

Page 1 of 1

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.