Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

Device Description

CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.

AI/ML Overview

The provided text describes a 510(k) submission for the "CLEARFIL CERAMIC PRIMER" device, which is a silane-coupling agent. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for a detailed AI/ML device study.

Instead, the core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as devices already on the market, rather than meeting specific quantifiable performance benchmarks like sensitivity/specificity for a diagnostic AI.

Here's an analysis based on the provided text, highlighting what is and is not present:

Key Takeaways from the document:

The device is a silane-coupling agent intended to enhance the adhesive surface for dental materials (porcelain, ceramics, hybrid ceramics, composite resin) and for intraoral repairs.
Substantial Equivalence: The primary method for proving the device's acceptability is through its similarity to predicate devices.
Performance Data: The document mentions "Tensile bond strength tests on the applicant device in comparison to the predicate devices" as evidence of effectiveness/performance. This is the only direct performance study mentioned, but no specific acceptance criteria or detailed results are provided.

Analysis against the Requested Information:

Since the provided document is a 510(k) summary focused on substantial equivalence rather than a detailed performance study with explicit acceptance criteria for an AI/ML device, much of the requested information (especially regarding AI-specific details like sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or not present.

Here's a breakdown based on the categories you requested, with responses tailored to the information available:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Implicit Criteria for Substantial Equivalence:
1. Chemical ingredients equivalent to predicate devices.	"All the chemical ingredients of the applicant device have been used in the predicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices."
2. Effectiveness/Performance (Tensile Bond Strength) as good as or better than predicate devices.	"Tensile bond strength tests on the applicant device in comparison to the predicate devices... tells (sic) the applicant device is as effective and performs as well as or better than the predicate devices."
3. Indications for Use align with predicate devices.	The Indications for Use listed for the CLEARFIL CERAMIC PRIMER are compared to those of predicate devices (Table 3), implying equivalence.
Explicit Numerical Acceptance Criteria:	Not explicitly stated. The document asserts "as well as or better than" but does not provide specific numerical thresholds for tensile bond strength or other metrics.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "Tensile bond strength tests" without details on the number of samples, replicates, or cases.
- Data Provenance: Not specified. The manufacturer is KURARAY MEDICAL INC., located in Japan. The tests were likely conducted internally or by a contracted lab, but the location and whether the data is retrospective or prospective are not mentioned.
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 / Not Present: This device is a chemical primer, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here would be the measured physical properties (e.g., tensile bond strength), not an expert consensus on an image or clinical case.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Present: As this is not an AI/ML diagnostic or interpretive device, adjudication methods for expert disagreement are irrelevant to the tensile bond strength testing mentioned.
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 / Not Present: This is not an AI-assisted device. Therefore, no MRMC study or analysis of human reader improvement with AI assistance was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Present: This is not an AI algorithm; it's a dental material.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: For the "Tensile bond strength tests," the "ground truth" would be the quantifiable physical measurement of the bond strength itself, obtained through laboratory testing. This is not subjective expert consensus, pathology, or outcomes data.
The sample size for the training set
- Not Applicable / Not Present: This device is not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established
- Not Applicable / Not Present: No training set exists for this type of device.

In summary: The provided document is a 510(k) summary for substantial equivalence of a dental primer, not a detailed technical report for an AI/ML device. Therefore, the information regarding specific acceptance criteria, detailed study design, sample sizes for training/test sets, expert involvement, and AI-specific performance metrics is largely absent or not applicable. The basis for acceptance is a qualitative assertion of "as well as or better than" predicate devices concerning chemical ingredients and tensile bond strength performance.

Summary

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[CLEARFIL CERAMIC PRIMER, KURARAY MEDICAL INC.]
Section 3: Summary

K061906

Image /page/0/Picture/1 description: The image is a logo for Kuraray. The logo is a black square with a white stylized letter "K" inside. The word "KURARAY" is printed in white letters below the square. The logo is simple and modern.

JRARAY MEDICAL. INC.

Quality Assurance Department

1-1-3 Otemachi, Chiyoda-ku, Tokyo, 100-0000 : +81-(0)3-6701-1706 Phone Facsimile: +81-(0)3-6701-1805

SEP 2 8 2006

Date: June 30, 2006

510(k) Summary

3-1. 510(k) owner (submitter)

1. Name

Address
Contact person
Contact person in U.S.

1604.0 K 1141.0 710.0

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Tukigawa Quality Assurance Department

KURARAY MEDICAL INC.

Koji Nishida KURARAY AMERICA INC. 101 East 52nd Street, 26th Floor New York, NY 10022 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

3-2. Name of Device

Classification name

CLEARFIL CERAMIC PRIMER 1) Trade / Proprietary name

Resin tooth bonding agent (21 CFF): section 872.3200. Product code: KLE)

Silane coupling agent

3-3. Predicate device

Common name
CLEARFIL PORCELAIN 510(k) Number: K012730 Product Code: BOND ACTIVATOR KLE 21 CFR Section: 872.3200 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL SE BOND 510(k) Number: K012442 Product Code: KLE 872.3200 21 CFR. Section: Applicant: KURARAY AMERICA, INC. 510(k) Number: K042913 3) CLEARFIL TRI-S BOND Product Code: KLE 21 CFR Section: 872.3200 Applicant: KURARAY COMPANY, LTD. 510(k) |Number: K905220 4) MONOBOND S Product Code: EBF 21 CFR Section: 872.3690 IVOCLAR NORTH AMERICA, INC. Applicant:

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3-4. Description of device

CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.

at is intended to be used for the indications listed in the right hand column of the below table that are equivalent to the predicate devices.

Table 3: Indications for Use and predicate devices

Indications for Use	Predicate devices
1) Surface treatment of porcelain,ceramics, hybrid ceramics or compositeresin	- MONOBOND S- CLEARFIL SE BOND (not indicating ceramics)- CLEARFIL TRI-S BOND and CLEARFILPORCELAIN BOND ACTIVATOR (notindicating ceramics or hybrid ceramics)
2) Intraoral repairs of fracturedcrowns/bridges made of porcelain,ceramics, hybrid ceramics or compositeresin	- MONOBOND S- CLEARFIL SE BOND (not indicating ceramics)- CLEARFIL TRI-S BOND and CLEARFILPORCELAIN BOND ACTIVATOR (notindicating ceramics or hybrid ceramics)

3-5. Technological characteristics of device

It can be said that the applicant device is as safe as, as effective, and performs as well as or better than the predicate devices with the followings:

1. Chemical ingredients
  All the chemical ingredients of the applicant device have been used in the predicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices.
1. Effectiveness / Performance
  Tensile bond strength tests on the applicant device in comparison to the predicate devices Tellshe bond sheight tests on the appass effective and performs as well as or better than the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K061906

Trade/Device Name: Clearfil Ceramic Primer Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: EBF Dated: June 30, 2006 Received: July 11, 2006

Dear Mr. Nishida:

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 cither 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. Nishida

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 Office of Compliance at (240) 276-0115. 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/industry/support/index.html.

Sincerely yours.

Snette Y. Michum Omd.

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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Indications for Use

$661906 510(k) Number (if known):

Device Name: ________________________________________________________________________________________________________________________________________________________________

Indications for Use:

1. Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
1. Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics,

hybrid ceramics or composite resin

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/C) R (Part 21 CFR 801 Subpart D)

Over-The-Counter Use __N/A (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)

Susan Runner

nesthesiology. General Hospital. Control. Dental E

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.