REVEAL Bulk is a light-activated restorative composite, optimized to allow for simpler and faster posterior restorations. REVEAL Bulk is intended to combine superior levels of handling, depth of cure, and polishability to perform as an optimum functional and aesthetic bulk fill composite.

AI/ML Overview

The provided document is a 510(k) summary for a dental restorative material called REVEAL Bulk. It does not describe a study involving an AI device or a comparative effectiveness study with human readers. Instead, it focuses on demonstrating substantial equivalence of REVEAL Bulk to an existing predicate device based on physical, mechanical, and biocompatibility properties.

Therefore, many of the requested categories for AI device studies, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and performance of the REVEAL Bulk device for its intended use as a dental restorative material.

Acceptance Criteria and Reported Device Performance for REVEAL Bulk

1. Table of Acceptance Criteria and Reported Device Performance:

Physical / Mechanical Property	Acceptance Criteria (based on ISO 4049:2009 for some tests and equivalence to predicate)	REVEAL Bulk Reported Performance
Diametral Tensile Strength	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicates.
Flexural Strength (ISO 4049:2009)	Meets requirements of ISO 4049:2009	Meets the requirements of ISO 4049:2009 for Flexural Strength.
Flexural Modulus	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate for Flexural Modulus.
Radiopacity (ISO 4049:2009)	Meets requirements of ISO 4049:2009	Meets the requirements of ISO 4049:2009 for Radiopacity.
Water Sorption (ISO 4049:2009)	Meets requirements of ISO 4049:2009	Meets the requirements of ISO 4049:2009 for Water Sorption.
Solubility (ISO 4049:2009)	Meets requirements of ISO 4049:2009	Meets the requirements of ISO 4049:2009 for Solubility.
Depth of Cure (ISO 4049:2009)	Predicate: 4 mm; REVEAL Bulk: 5 mm (considered an improvement)	5 mm
Volumetric Shrinkage	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate.
Compressive Strength	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate.
Wear	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate.
Polish Retention	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate.
Surface Hardness	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate.
Cusp Deflection	Equivalent to predicate (Filtek Bulk Fill K141081)	Equivalent to the predicate.
Biocompatibility (ISO 7405:2008 & 10993-1)	Meets requirements of biocompatibility standards	Meets the requirements of the testing (Cytotoxicity).

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes (number of specimens) used for each physical/mechanical test.
The data provenance is from laboratory testing conducted by Bisco, Inc. (the applicant) on their REVEAL Bulk device. The standards referenced (e.g., ISO 4049:2009, ISO 7405:2008, ISO 10993-1) are international standards for dental materials and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the "ground truth" for this medical device submission relies on established international standards (e.g., ISO for physical properties) and scientific principles for material characterization, rather than human expert consensus on diagnostic images or clinical outcomes. The performance is measured against these objective standards and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

This question is not applicable as there is no human interpretation or adjudication involved in the objective physical and mechanical property testing of a dental restorative material. The results are quantitative measurements against defined criteria.

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 question is not applicable. The submission is for a dental restorative material, not an AI device. No MRMC study was conducted.

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

This question is not applicable. The submission is for a dental restorative material, not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on established international standards and predicate device performance. For example:
- ISO 4049:2009 for polymer-based restorative materials, specifying test methods and requirements for properties like flexural strength, radiopacity, water sorption, solubility, and depth of cure.
- ISO 7405:2008 and ISO 10993-1 for biological evaluation of medical devices (biocompatibility).
- Equivalence to a legally marketed predicate device (Filtek Bulk Fill K141081) for other properties like diametral tensile strength, volumetric shrinkage, compressive strength, wear, polish retention, surface hardness, and cusp deflection.

8. The sample size for the training set:

This question is not applicable. This is not an AI device or a machine learning model, so there is no "training set."

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

This question is not applicable. There is no training set for this type of device submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 4, 2017

Bisco. Inc. Rvan Hobson Regulatory Affairs Product Registration Coordinator 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K171147

Trade/Device Name: REVEAL Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: May 10, 2017 Received: May 11, 2017

Dear Ryan Hobson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Andrew I. Steen -S

for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171147

Device Name REVEAL Bulk

Indications for Use (Describe)

1. Direct anterior and posterior restorations (including occlusal surfaces)
1. Base/liner under direct restorations
1. Core build-ups
1. Splinting
1. Indirect restorations including inlays, onlays and veneers
1. Restorations of deciduous teeth
1. Extended fissure sealing in molars and premolars
1. Repair of defects in porcelain restorations, enamel, and temporaries

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the BISCO company logo. The logo consists of five three-dimensional hexagons in a row, alternating between red and blue. The word "BISCO" is written in large, bold letters below the hexagons, with the top half of the letters in gray and the bottom half in black.

510 (k) SUMMARY

Applicant:

Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193

Contact Person:

Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143

Date Prepared: 10 May 2017

Trade Name: Common Name: Product Code: Classification/Name: REVEAL Bulk Light-Cured Bulk Fill Composite EBF Tooth Shade Resin Material Class II per 21 CFR 872.3690

Predicate Devices:

REVEAL Bulk is substantially equivalent to:

Filtek Bulk Fill Posterior Restorative, by 3M ESPE, K141081

Indications for Use:

1. Direct anterior and posterior restorations (including occlusal surfaces)
1. Base/liner under direct restorations
1. Core build-ups
1. Splinting
1. Indirect restorations including inlays, onlays and veneers
1. Restorations of deciduous teeth
1. Extended fissure sealing in molars and premolars
1. Repair of defects in porcelain restorations, enamel, and temporaries

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Image /page/4/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of connected hexagons in red and blue colors. Below the hexagons, the word "BISCO" is written in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.

510 (k) SUMMARY (continued)

The indications for use of REVEAL Bulk are identical to those for Filtek Bulk Fill (K141081) and are summarized in the table below:

Filtek Bulk Fill (K141081)	REVEAL Bulk
Direct anterior and posterior restorations (including occlusal surfaces) Base/liner under direct restorations Core build-ups Splinting Indirect restorations including inlays, onlays and veneers Restorations of deciduous teeth Extended fissure sealing in molars and premolars Repair of defects in porcelain restorations, enamel, and temporaries	Direct anterior and posterior restorations (including occlusal surfaces) Base/liner under direct restorations Core build-ups Splinting Indirect restorations including inlays, onlays and veneers Restorations of deciduous teeth Extended fissure sealing in molars and premolars Repair of defects in porcelain restorations, enamel, and temporaries

Description of Applicant Device:

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Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, with the two outer hexagons being red, the middle hexagon being blue, and the two inner hexagons being white. Below the hexagons is the word "BISCO" in gray and black.

510 (k) SUMMARY (continued)

Technological Characteristics:

All components of REVEAL Bulk are based upon industry standard chemistry. The chemical composition of REVEAL Bulk is similar to Filtek Bulk Fill (K141081) summarized in the table below:

Chemical Composition	Filtek Bulk Fill (K141081)	REVEAL Bulk
Filler	Inorganic glass fillers(Ceramic, Silica, Zirconia, YtterbiumFluoride)	Inorganic glass fillers(Barium and Ytterbium Fluoride)


Resin composition	Methacrylate based resin matrix	Methacrylate based resin matrix
Adhesion	Requires use of dental adhesive	Requires use of dental adhesive
Polymerization Method	Light induced polymerization to forma hard composite.	Light induced polymerization to form ahard composite.

Physical Mechanical Property	Filtek Bulk Fill (K141081)	Reveal Bulk
Radiographic Appearance	Radiopaque	Radiopaque
Depth of Cure	4 mm	5 mm
Delivery system	Syringe and unit-dose	Syringe and unit-dose

The difference in filler is REVEAL Bulk's use of Barium Glass, an industry standard filler and is substantially equivalent in performance to Filtek Bulk Fill's fillers. Additionally, REVEAL Bulk's depth of cure, from a single point cure, is 5mm as determined by ISO 4049:2009(E), an improvement, and does not raise new questions of safety or efficacy. Both REVEAL Bulk and the predicate device are methacylate based light cured composite devices that require the use of a dental adhesive and are available in syringes and unit dose.

BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.

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510 (k) SUMMARY (continued)

Performance Data:

The following physical/mechanical properties of REVEAL Bulk were tested:

Physical / Mechanical Property	REVEAL Bulk
Diametral Tensile Strength	REVEAL Bulk is equivalent to the predicates.
Flexural Strength / FlexuralModulus(ISO 4049:2009)	REVEAL Bulk meets the requirements of ISO 4049:2009 forFlexural Strength. REVEAL Bulk is equivalent to the predicatefor Flexural Modulus.
Radiopacity(ISO 4049:2009)	REVEAL Bulk meets the requirements of ISO 4049:2009 forRadiopacity.
Water Sorption and Solubility(ISO 4049:2009)	REVEAL Bulk meets the requirements of ISO 4049:2009 forWater Sorption and Solubility.
Depth of Cure (ISO4049:2009)	Predicate: 4 mm, REVEAL Bulk: 5 mm
Volumetric Shrinkage	REVEAL Bulk is equivalent to the predicate.
Compressive Strength	REVEAL Bulk is equivalent to the predicate.
Wear	REVEAL Bulk is equivalent to the predicate.
Polish Retention	REVEAL Bulk is equivalent to the predicate.
Surface Hardness	REVEAL Bulk is equivalent to the predicate.
Cusp Deflection	REVEAL Bulk is equivalent to the predicate.

Biocompatibility:

An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of REVEAL Bulk. It is concluded from the evaluation and the results of the Cytotoxicity testing that REVEAL Bulk meets the requirements of the testing.

Conclusion:

It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that REVEAL Bulk is substantially equivalent in safety and effectiveness to the predicate device.

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.