BISCOVER LV is a low viscosity, light-cured resin formulation used to seal restorations and etched enamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LV cures without any sticky oxygen-inhibited layer. BISCOVER LV may reduce or even eliminate the need for manual polishing.

AI/ML Overview

The provided document is a 510(k) premarket notification summary and the FDA's substantial equivalence letter for a dental surface sealant named BISCOVER LV. It does not contain information about a study with specific acceptance criteria that proves device performance in the way typically seen for diagnostic or AI-enabled devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on its intended use, chemical composition, and mechanical/physical properties. Here's a breakdown of the information that is available, structured to match your request where possible, and noting where information is absent:

1. Table of acceptance criteria and the reported device performance

Property/Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (BISCOVER LV)
Intended use	Resin sealant	Resin sealant
Chemical composition	Light-Cured, Multifunctional Acrylate Resin	Light-Cured, Multifunctional Acrylate Resin
Mechanical/physical properties	Low viscosity clear resin liquid, light cured to smooth polish surface	Low viscosity clear resin liquid, light cured to smooth polish surface
Biocompatibility	Not explicitly stated as a criterion, but implied	Non-toxic (based on testing)

Note: The "acceptance criteria" here are implicitly the characteristics of the predicate device, BISCOVER Liquid Polish, as the goal is to demonstrate "substantial equivalence." The reported performance for BISCOVER LV essentially matches these characteristics, indicating it meets the implicit "acceptance criteria" for equivalence.

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 provided in the document. The submission states, "Side by side comparisons of BISCOVER LV to the predicate device BISCOVER Liquid Polish clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device." However, no details on the sample size or provenance of these comparisons are given.

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 and not provided. This type of information is relevant for studies involving subjective human assessment or diagnostic accuracy, which is not the nature of this submission for a dental material.

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

This information is not applicable and not provided. This is typically relevant for studies where a "ground truth" needs to be established through expert consensus, which wasn't the method for evaluating this dental material.

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 and not provided. This type of study is relevant for diagnostic devices involving human interpretation, especially AI-assisted ones. BISCOVER LV is a dental material, not a diagnostic tool, and involves no "human readers" in this context.

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

This information is not applicable and not provided. This is relevant for AI algorithms, which BISCOVER LV is not. The evaluation of BISCOVER LV involved direct testing of its material properties and comparison to a predicate device.

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

The "ground truth" in this context is the established characteristics and performance of the predicate device (BISCOVER Liquid Polish). The "study" (or rather, the testing) aimed to show that BISCOVER LV possessed similar or identical properties (intended use, chemical composition, mechanical/physical properties) and was biocompatible.

8. The sample size for the training set

This information is not applicable and not provided. Dental materials are not "trained" like AI algorithms. Their properties are inherent to their formulation and manufacturing process, and verified through laboratory and biocompatibility testing.

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

This information is not applicable and not provided. As above, the concept of a "training set" and "ground truth for a training set" does not apply to the evaluation of this dental material. The "ground truth" for the comparison was derived from the characteristics of the legally marketed predicate device.

Summary of the Study/Evaluation:

The provided document describes a substantial equivalence determination rather than a traditional clinical study with defined performance metrics against a ground truth as one might expect for a diagnostic device. The "study" involved:

Comparison of properties: Side-by-side comparison of BISCOVER LV's intended use, chemical composition, and mechanical/physical properties with those of the predicate device, BISCOVER Liquid Polish.
Biocompatibility testing: BISCOVER LV was tested and found to be non-toxic.

The conclusion drawn is that BISCOVER LV is "substantially equivalent" to BISCOVER Liquid Polish, satisfying the requirements for 510(k) clearance based on its safety and efficacy being comparable to a legally marketed device. Specific details on the methodologies (e.g., how many samples were tested for viscosity or surface smoothness, what exact biocompatibility tests were performed) are not included in this summary.

Summary

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Image /page/0/Picture/0 description: The image shows the date "FEB - 1 2005" at the top. Below the date is a handwritten number, "K043168". The date is printed in a simple, sans-serif font, while the number is written in a cursive style. The image appears to be a scan or photocopy of a document.

Page 5-1

Section 5 510 (k) SUMMARY

Applicant:	Bisco, Inc.1100 W. Irving Park RoadSchaumburg IL, 60193
Contact Person:	Benjamin LichtenwalnerTel: 847-534-6146Fax: 847-534-6111
Date Prepared:	November 15, 2004
Trade Name:	BISCOVER LV
Common Name:	Surface Sealant
Classification/Name:	Coating Material for Resin FillingsClass II per 21 CFR 872.3310

Description of Applicant Device:

Intended uses of Applicant Device:

BISCOVER LV is used to seal and polish direct composites (cured), indirect composites, provisionals, acrylig appliances, Resin-Modified Glass Ionomers, Enamel before or after orthodontic bracement, and etched Enamel.

Predicate Devices: BISCOVER Liquid Polish (K030354) dated February 19, 2003.

Significant Performance Characteristics:

BISCOVER LV to BISCOVER Liquid Polish

Property	BISCOVER	BISCOVER LV
Intended use	Resin sealant	Resin sealant
Chemical composition	Light-Cured, MultifunctionalAcrylate Resin	Light-Cured, MultifunctionalAcrylate Resin
Mechanical /physicalproperties	Low viscosity clear resin liquidlight cured to smooth polishsurface	Low viscosity clear resin liquidlight cured to smooth polishsurface

Side by side comparisons of BISCOVER LV to the predicate device BISCOVER Liquid Polish clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LV was tested for biocompatibility and was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER LV.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, stacked on top of each other.

Public Health Service

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193

Re: K043168

Trade/Device Name: BISCOVER LV Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: January 24, 2005 Received: January 25, 2005

Dear Mr. Lichtenwalner:

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 approvisions 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 (1 Nr.), It may of buryer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lichtenwalner

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of act FDA has made a determination that your device complies with other requirements moan that I Dr I has made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bakes and squirements, including, but not limited to: registration 1 ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirences as bet ferin in all of 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) I mis letter will and in Jorde FDA finding of substantial equivalence of your device to a premarket notification - I s 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), If you desire specific at no a 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 may obtain other generational 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,

Chiu Lin, Ph.D.

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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510 (k) Number (if known):

BISCOVER LV Device Name:

Indications for Use:

BISCOVER LV is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.

BISCOVER LV is used to Seal and Polish:

1. Direct composites (cured)
1. Indirect composites
1. Provisionals
1. Acrylic appliances
1. Resin-modified Glass Ionomers
1. Enamel before or after orthodontic bracket placement
1. Etched Enamel

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Ruma

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Olvision of Anesthesiology, General Hospital, Inrection Control. Dental Devices

310(k) Number K043161

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.