A-Wear™ provides the dentist with a composite designed to yield high resistance to wear and abrasion and excellent polishing characteristics. In addition to these properties, Aand ublighty translucent (opacity <40%). A- Wear™ is cured by heat and light and is designed to be used with high quality dentin/enamel adhesive systems.

AI/ML Overview

The provided text is a 510(k) submission for a dental composite material called A-Wear™. While it provides information about the device's intended use and legal marketing status, it does not contain details about specific acceptance criteria and the studies that prove the device meets these criteria in the way you've outlined.

The document discusses the device's properties (high resistance to wear and abrasion, excellent polishing characteristics, translucent opacity) by description and comparison to a predicate device (Micronew™), but it does not present quantifiable acceptance criteria or study results to demonstrate these claims.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The information requested typically comes from performance testing sections of a submission, which are not present here.

However, I can extract the following limited information where available:

Acceptance Criteria and Device Performance (Based on descriptive claims, no quantitative data available):

Acceptance Criteria	Reported Device Performance
High resistance to wear and abrasion	A-Wear™ is designed to yield high resistance to wear and abrasion.
Excellent polishing characteristics	A-Wear™ has excellent polishing characteristics.
Opacity	A-Wear™ is highly translucent (opacity <40%).

Information not available in the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The document is a regulatory submission, not a study report.
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 for this type of device (dental composite) and information provided. Ground truth would typically be related to clinical outcomes or material property measurements, not expert consensus on images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not 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. This is a dental material, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned, but for a dental composite, ground truth would be based on validated material testing standards (e.g., ISO standards for wear, abrasion, translucency, bonding strength).
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of what is provided and what is not provided:

The provided text focuses on:

Identifying the legally marketed predicate device (Micronew™).
Describing the applicant device (A-Wear™) and its intended uses.
Stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

It does not include the detailed technical study reports, material testing results, or clinical data that would typically contain the acceptance criteria and performance data you've asked for. This level of detail would be in supporting documentation within the full 510(k) submission, not typically in the summary or clearance letter provided.

Summary

{0}------------------------------------------------

BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) Submission for A-Wear™

21 of 24

K012180

SUMMARY

Legally Marketed Predicate Device Micronew™

Micronew™ is a translucent composite designed to yield high resistance to wear and Microw - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - indirect or direct restorations.

Description of Applicant Device A-Wear™

Intended Uses of Applicant Device A-Wear™

A-Wear™ is intended for direct or indirect class III, IV, and V restorations and diastema closures. A-Wear™ is also intended for composite restorations bonded to tooth structure, metal, composite, fiber-reinforced substructure, and porcelain.

{1}------------------------------------------------

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, suggesting movement or flight. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

Mr. Steven J. Duray Mr. Beeven of Technical Business Support Services Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re : K012180 Trade/Device Name: A-Wear 872.3690 Requlation Number: Requlatory Class: II EBF Product Code: July 11, 2001 Dated: Received: July 12, 2001

Dear Mr. Duray:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Title 21, Parts 800 to 895. ਸ Federal Regulations, 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 regulation (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 action. In addition, FDA may publish further announcements

{2}------------------------------------------------

Paqe 2 - Mr. Duray

concerning your device in the Federal Register. Please note: this 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 deborizod in formalence of your device to a legally marketed predicate device results in a classification for your markets processor with your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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 qeneral 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,

A. Ulatowski Timo Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{3}------------------------------------------------

BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) Submission for A-Wear™

INDICATIONS FOR USE

510(k) Number (if known):	K012180
Device Name:	A-Wear™

Indications for Use:

1. Direct or indirect class III, IV, and V restorations.
Diastema closures. 2.
1. Composite restorations bonded to tooth structure.
1. Composite restorations bonded to metal.
1. Composite restorations bonded to composite or fiber-reinforced substructure.
Composite restorations bonded to porcelain. ે.
1. Direct or indirect veneers.

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)

Prescription for Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)
	(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K02180

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.