ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.
Intended Use of ILLUSION: dental resin cement

Device Description

AI/ML Overview

The provided text describes a 510(k) summary for a dental resin cement called ILLUSION. It aims to establish substantial equivalence to a predicate device, "Choice™," and lacks detailed information typically found in a study report, particularly regarding acceptance criteria and performance data for a medical device that would involve human subjects or complex algorithms.

However, based on the provided information, I can extrapolate the "acceptance criteria" and "device performance" relating to the physical and mechanical properties of the dental cement as these are explicitly compared to the predicate device.

Here's the breakdown of the information as requested, using the available data:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (dental resin cement), the "acceptance criteria" are implied by the performance of the legally marketed predicate device, Choice™. The new device, ILLUSION, is deemed "substantially equivalent" if its performance falls within a comparable range to the predicate device, demonstrating similar safety and effectiveness for its intended use.

Technological Characteristic	Acceptance Criteria (Predicate Device: Choice™)	Reported Device Performance (ILLUSION™)
Intended Use	Cement	Cement
Chemical Composition	Dual-cured	Dual-cured
Physical/Mechanical Properties:
Diametrical Tensile Strength (Light-cured)	49 MPa	43 MPa
Diametrical Tensile Strength (Chemical-cured)	38 MPa	41 MPa
Compressive Strength (Light-cured)	198 MPa	260 MPa
Compressive Strength (Chemical-cured)	N/A (not reported for predicate)	231 MPa
Barcol Hardness (L/C 20 sec., 2 mm thickness)	79/60	82/59
Modulus (Light-cured)	8.7 GPa	5.6 GPa
Working Time (Min:Sec)	5:00/10:00	4:30/9:30

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) Summary, which typically references internal testing reports rather than providing them in full detail. The "study" mentioned here refers to the testing conducted by Bisco, Inc. to compare ILLUSION's properties against its predicate. The FDA reviewed these undisclosed test results and determined substantial equivalence.

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

Sample Size for Test Set: The table indicates numerical values followed by a number in parentheses (e.g., "49 MPa (8)"). This "(8)" or "(6)" likely represents the number of samples or measurements taken for that specific physical property test (e.g., 8 samples for diametrical tensile strength, 6 for compressive strength). This is a very small sample size for a "test set" in the context of clinical studies, but common for material property testing.
Data Provenance: The data is generated by Bisco, Inc., a company located in Schaumburg, IL, USA. This would be considered experimental/laboratory data rather than clinical data, and it is prospective in the sense that the testing was performed specifically to characterize the new device. There is no information regarding the country of origin of the data beyond the company's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of submission. For dental cements, "ground truth" is typically established through standardized material property testing, according to recognized ASTM or ISO standards, rather than expert interpretation or clinical consensus. There are no "experts" in the sense of clinicians establishing ground truth for physical properties like tensile strength or hardness, but rather skilled technicians performing tests according to methods.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader interpretations (e.g., radiology images) to resolve discrepancies among experts. For physical property testing, results are quantitative and typically averaged or analyzed statistically; there's no "adjudication" in this sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic devices involving human interpretation of clinical data (e.g., radiologists reading images). This 510(k) is for a dental material (cement), and its assessment relies on material properties rather than diagnostic performance or human reader interaction.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a "standalone algorithm performance" study was not done. This concept applies to AI/software as a medical device. ILLUSION is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the physical and mechanical properties of the dental cement is established by standardized testing methods (e.g., ISO, ASTM standards for dental materials) that yield quantitative measurements. The predicate device's performance provides the benchmark against which the new device's properties are compared. There is no pathology, outcomes data, or expert consensus used for these specific material properties.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device like a dental cement, there is no "training set" in this context. The characteristics of the material are inherent to its composition and manufacturing process, optimized through formulation development and testing.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no "training set" for this type of device.

Summary

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K 993192

510(k) Summary ILLUSIONTM

1: Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 847-534-6000 Contact: Kathryn B. Patterson, Regulatory Affairs Manager Date Propared: September 14, 1999
1. · Device Trade Name: ILLUSION Common/Usual Name: Dental Resin Cement Classification Name: Dental Cement [21 CFR 872.3275]
Choice™, K875313 (cleared March 10, 1988) ന് Predicate Device:
ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) 4. system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlavs, crowns and fixed partial dentures.
ડ, Intended Use of ILLUSION:
- . dental resin cement
II.LUSION possesses the same tcchnological characteristics as the predicate device, Choice. ਦੋ Below is a table which shows a side-by-side comparison of the technological characteristics.

Technological Characteristic	Choice	ILLUSION
Intended Use	Cement	Cement
Chemical Composition	Dual-cured	Dual-cured
Physical/Mechanical Properties:
Diametrical Tensile Strength (L/C*)	49 MPa (8)	43 MPa (8)
Diametrical Tensile Strength(C/C**)	38 MPa (8)	41 MPa (8)
Compressive Strength (L/C)	198 MPa (6)	260 MPa (6)
Compressive Strength (C/C)	N/A	231 MPa (6)
Barcol Hardness (L/C 20 sec., 2 mmthickness)	79/60 (3)	82/59 (3)
Modulus (L/C)	8.7 GPa (5)	5.6 GPa (5)
Working Time (Min:Sec)	5:00/10:00	4:30/9:30

*Light-cured

**Chemical-cured

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

Ms. Kathryn B. Patterson Regulatory Affairs Manager Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193

K993192 Re :

Illusion Trade Name: Regulatory Class: II Product Code: EMA Dated: August 23, 1999 Dated. August 24, 1999

Dear Ms. Patterson:

We have reviewed your Section 510 (k) notification of intent to
r the may be have founded above and we have determined the We have reviewed your section 310(x) hours betermined the
market the device referenced above and we have indications for market the device referenced above and wo market ons for
device is substantially equivalent (for the indications for device is substantially equivalent (ior encreated in interstate
use stated in the enclosure) to devices marketed in interstate
n the enclosed in the May 28, 1976 the enactme use stated in the enciosure) co de readstment date of the commerce prior to May 26, 1978, che sices that have been
Medical Device Amendments, or to devices that have of the F Medical Device Amendents, of Co devices cias now of the Federal reclassified in accordance with the provinay, therefore, Food, Drug, and Cosmeric Acc (noc). Provisions provisions
market the device, subject to the general controls of the Act evice, subject co the gonvisions of the Act of the Act. of the Act. The general concrols pistration, listing of
include requirements for annual regist go, labeling, and include requirements For annuralice, labeling, and devices, good manufacturing ping and adulteration.

If your device is classified (see above) into either class II
n the see and the cases of a TIT (Promaxker, Approval), it may If your device 15 class III (Premarket Approval), it may
(Special Controls) or class III (Premarket Approval), Evisting major (Special Controls) of Crass Irr (Special - Existing major
be subject to such additional controls. Existing major be subject to such addressional our device can be found in the Code of regulations arrecting your at Parts 800 to 895. A Eederal Regulations, firtle zi, rares essumes compliance with
substantially equivalent determination nevices: General substantially equivalent deteimination icalina.
the Good Manufacturing Practice for Medical Devices: chrough periodic the Good Manufacturing Practice 201 and that through periodic
(GMP) regulation (21 CFR Part Rout Rough Stration (FDA) will (GMP) regulation (2) Crk Farc over administration (PDA) will GMP inspections, the rood and been and with the GMP verify such assumptions. Farlatory action. In addition, FDA regulation may resure in regarats concerning your device in
may publish further announcements concerning your and may publish further announcements contrise of this response to your the Federal Register. Freasons in affect any

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Paye 2 - Ms. Patterson

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions ander the Biections Product Radiations.

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) , and additionally 809.10 for
Compliance at (201) 50 1500 150 Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-1639. Also, please note the regulation entifica, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

#hy 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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Attachment 2 - Indications for Use

Indications for Use

510(k) Number (if known): K875313

Device Name: ILLUSION™

Indications for Use:

Dental Resin Cement 1.

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

Prescription Use X (Per 21 CFR 801.109)

us-567 -4. V. Da

(Division Sign-Off) Division of Dental, Infection Control, Invision of Dental, Infection Gontrollorio 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

000002

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.