This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

AI/ML Overview

This 510(k) summary describes a new dental restorative material, CLEARFIL AP-X PLT, which is substantially equivalent to a previously cleared device, CLEARFIL AP-X. Due to this substantial equivalence claim for a dental material, the provided document does not contain information typically found in studies for AI/ML-powered medical devices. Therefore, I cannot provide a detailed response for points 2 through 9 as they are not applicable or the information is not present in the provided text.

Here's what I can extract and infer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a dental material, "acceptance criteria" and "device performance" are typically related to material properties (e.g., strength, biocompatibility, setting time, wear resistance, color stability) which are evaluated against industry standards or the predicate device's established performance. The submission is based on substantial equivalence, implying that the new device meets or performs similarly to the predicate.

Acceptance Criteria Category	Reported Device Performance (CLEARFIL AP-X PLT)
Technological Characteristics	Substantially the same as CLEARFIL AP-X (K012740)
Chemical Ingredients	Substantially the same as CLEARFIL AP-X (K012740)
Safety	Substantially the same as CLEARFIL AP-X (K012740)
Intended Use	Same as CLEARFIL AP-X (K012740)
Classification	Same as CLEARFIL AP-X (K012740) - Tooth shade resin material, 21 CFR 872.3690

Study Proving Acceptance Criteria:
The document states, "This device is substantially same to CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740). Therefore CLEARFIL AP-X and CLEARFIL AP-X PLT are substantially equivalent on the technological characteristics, chemical ingredients and safety."

This statement implies that the "study" proving acceptance criteria is a comparison of the new device (CLEARFIL AP-X PLT) to its predicate device (CLEARFIL AP-X) across these characteristics. However, the details of this comparative study (e.g., specific tests, methodologies, results of material properties) are not included in this 510(k) summary. These details would typically be in the full submission, but not in the summary document.

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

This information is not applicable to this type of 510(k) submission for a dental composite material, which does not involve a "test set" in the context of an AI/ML device. The "test" here refers to material testing or equivalence comparisons, not clinical image or diagnostic data.

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 information is not applicable. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for this material-based device submission.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, not for material equivalence comparisons.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable in the typical sense. For a dental material, "ground truth" might refer to established physical, chemical, and biological properties measured by standardized tests, rather than clinical diagnostic ground truth. The basis for declaring equivalence is a comparison of these material properties, not a diagnostic outcome.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

Summary

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OCT 2 5 2002

[CLEARFIL AP-X

Image /page/0/Picture/3 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is also shaped like a square. Below the symbol is the word "KURARAY" in a bold, sans-serif font.

KURARAY MEDICAL INC.

Dental Material Department 3-1-6 Nihonbashi, Chuo-ku, Tokyo 103-8254, Japan Tel : +81.3.3277.6949 Fax : +81.3.3277.6956

510(k) SUMMARY

1. Submitter
1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) 1. Contact person	Koji Nishida
	Dental Material Department, Kuraray Medical Inc.

Masaya Sasaki 2. Contact person in U.S.A. Kuraray America Inc. 101 East 52nd Street, 26th Floor New York, NY 10022 Telephone : (212)-986-2230 (Ext.115) 1-(800)-879-1676 Facsimile : (212)-867-3543 4) Date August 25, 2002

2. Name of Device

1) Proprietary Name	CLEARFIL AP-X PLT
2) Classification Name	Tooth shade resin material (21CFR 872.3690)
3) Common/Usual Name	Composite resin restorative

1. Predicate device:
  The predicate device is as follow.

CLEARFIL AP-X by Kuraray Medical Inc. (K012740)

1. Description for the premarket notification
  This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

5. Statement of the intended use

The intended uses of this device are as follows. They are the same as CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740).

Class I, II, V restorations of posterior teeth 1)
Class III, IV, V restorations of anterior teeth 2)
1. Cervical cavities or defects involving root surfaces

Statement of the technological characteristics and safety

This device is substantially same to CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740). Therefore CLEARFIL AP-X and CLEARFIL AP-X PLT are substantially equivalent on the technological characteristics, chemical ingredients and safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

OCT 2 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical, Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K023002

Trade/Device Name: CLEARFIL AP-X PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth-Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 04, 2002 Received: September 09, 2002

Dear Ms. Sasaki:

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.

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.

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Page 2 - Ms. Masaya Sasaki

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timot 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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KO23002 510(k) Number (if known): .

Device Name: CLEARFIL AP-X PLT

Indications for Use

CLEARFIL AP-X PLT is indicated for the following applications:

Class I, II, V restorations of posterior teeth

1. Class III, IV, V restorations of anterior teeth

Cervical cavities or defects involving root surfaces

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

La Aulhuts

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number ._

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.