Point 4 Flowable is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Device Description

AI/ML Overview

I am able to extract the requested information and have provided it below. Please note that the document provided is a 510(k) summary for a dental restorative material, which primarily focuses on demonstrating substantial equivalence to a predicate device based on material properties, mechanical testing, and intended use, rather than clinical performance data typical for AI/ML-driven devices. Therefore, many of the requested fields related to clinical study design, ground truth, and reader studies are not applicable or cannot be found in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

Based on the provided document, the "acceptance criteria" for Point 4 Flowable are primarily established by demonstrating substantial equivalence to a legally marketed predicate device (Kerr Corporation, Revolution Formula 2). The "device performance" is described through its physical and chemical properties and intended use, aligning with the predicate. Specific quantitative acceptance criteria with reported performance values in the context of clinical efficacy or diagnostic accuracy, as would be expected for a software device, are not present in this 510(k) summary. This document does not describe a "standalone" performance evaluation in the context of an AI algorithm's diagnostic accuracy.

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Substantial Equivalence	Device functions in a manner similar to and is intended for the same use as the predicate device.	"Point 4 Flowable is substantially equivalent to other legally marketed devices in the United States. The composite restorative marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center."
Intended Use Safety & Efficacy	Suitable for specified dental restorations and functions.	"Point 4 Flowable is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups."
Material Classification	Meets classification for Tooth Shade Resin Material.	Classified as "Tooth Shade Resin Material, per 21 CFR § 872.3690."

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

Not applicable in this document. The 510(k) summary for "Point 4 Flowable" describes a conventional dental restorative material, not a device that underwent testing with a "test set" of patient data in the typical sense for an AI/ML device. The determination of substantial equivalence is based on material properties, physical testing, and intended use, not clinical trial data with a 'test set' of patient images or diagnostic outcomes.

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

Not applicable. As described above, this document does not refer to a test set requiring ground truth established by experts for diagnostic or performance evaluation in the context of an AI/ML device.

4. Adjudication Method for the Test Set:

Not applicable. No "test set" requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a 510(k) for a dental material, not an AI/ML diagnostic aid that would typically undergo an MRMC study to evaluate human reader improvement with AI assistance.

7. Type of Ground Truth Used:

Not applicable for a device of this type in the context of clinical diagnostic accuracy. "Ground truth" for this device would refer to its material properties and chemical composition meeting specifications, rather than clinical outcomes or expert consensus on diagnostic interpretations.

8. Sample Size for the Training Set:

Not applicable. This document pertains to a physical dental material, not an AI/ML device that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth in that context.

Summary

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AUG 2 7 2001

Image /page/0/Picture/1 description: The image shows a logo for "Sybron Dental Specialties". The logo features the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a simple, sans-serif font. The logo is black and white.

K012321

SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: July 2001

Device Name:

Trade Name Point 4 Flowable .
Common Name Light-Curable Dental Restorative Material .
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, Revolution Formula 2 .

Device Description:

Intended Use of the Device:

The intended use of Point 4 Flowable is for use as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Substantial Equivalence:

Point 4 Flowable is substantially equivalent to other legally marketed devices in the United States. The composite restorative marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird with stylized wings and body.

AUG 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Collen Boswall Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re : K012321 Trade/Device Name: Point 4 Flowable 21 CFR 872.3690 Requlation Number: Requlatory Class: II Product Code: EBF Dated: July 18, 2001 Received: July 23, 2001

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Ms. Boswell

his response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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 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/dsmamafin.html/

Sincerely,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO12321

Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

Labels	Values
510(k) Number (if known):	K012321

Device Name: Point 4 Flowable

Indications For Use:

Point 4 Flowable is a low viscosity light cure hybrid resin restorative suitable for Class III, Class
IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of
porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure
sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)

ASBete DDS for Dr. Rume
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number K012321

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.