TheraCal LC is a light-cure resin-based, mineral trioxide aggregate (MTA) filled, liner designed Theracal De is a liner and pulp capping material. Its physical properties and uses are similar to the predicate device.

Liner
Pulp capping agent

Device Description

TheraCal LC is a light-cured resin-based, mineral trioxide aggregate (MTA) filled, liner designed to perform as a barrier and to protect the dental pulpal complex. TheraCal LC's precise alacement allows its use in all deep cavity preparations. The light-cured set permits the practitioner immediate placement and condensation of the restorative material. Its proprietary practitioner intines for a command set with a visible light curing unit while maintaining ease of formulation anows for a ochimaners and one oprietary hydrophilic resin formulation creates a stable and durable liner or base.

AI/ML Overview

This looks like a 510(k) summary for a dental product, TheraCal LC, which is a cavity liner and pulp capping material. The document states that the device is substantially equivalent to a predicate device, Prisma VLC Dycal.

However, the provided text does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) that you're asking for. In 510(k) submissions for devices like TheraCal LC, the "performance" typically refers to physical and chemical properties and biocompatibility, as compared to a predicate device, rather than diagnostic AI algorithm performance.

Here's a breakdown based on the absence of the requested information in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Expected based on typical dental material evaluation)	Reported Device Performance (from text)
Biocompatibility: Non-toxic	"TheraCal LC was tested for biocompatibility and it was found to be non-toxic."
Intended Use: Liner & Pulp Capping Material	"TheraCal LC is a liner and pulp capping material." (Stated intent)
Chemical Composition: Light-cured, MTA filled, resin liner	"Light-cured, MTA (Mineral Trioxide Aggregate) filled, resin liner"
Mechanical/Physical Properties: Low viscosity, dispensable composite	"Low viscosity, dispensable composite"
Substantial Equivalence to Predicate	"Side by side comparisons of TheraCal LC to the predicate device Prisma VLC Dycal clearly demonstrates that the applicant device is substantially equivalent to the legally marked device."

Critique: The provided text only broadly states "significant performance characteristics" and "side by side comparisons." It does not provide specific quantitative acceptance criteria (e.g., "flexural strength must be > X MPa") or the numerical results of those performance tests. It relies on a qualitative statement of "substantially equivalent."

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

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned. The study is for a physical dental material, so "data provenance" in the AI sense isn't directly applicable. The testing would have been conducted in a laboratory setting.
Retrospective or Prospective: Not applicable for this type of material testing.

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

Not applicable. This device is a physical dental material, not an AI diagnostic device that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. No expert review or adjudication process is described for this type of product testing.

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

No. An MRMC study is relevant for diagnostic imaging or AI systems where human readers interpret cases. This is a physical dental material.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only) Performance Was Done

No. This refers to AI algorithm performance. TheraCal LC is a physical dental material.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic performance. For a dental material, "ground truth" would relate to objective measurements of physical, chemical, and biological properties (e.g., cytotoxicity tests, adhesion strength tests, etc.) compared against industry standards or the predicate device. The document only states "biocompatibility and it was found to be non-toxic" without detailing the specific tests or their "ground truth" values.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary of Study Information Provided:

The study referenced in the 510(k) summary is a "side by side comparison" of TheraCal LC to the predicate device, Prisma VLC Dycal. This comparison likely involved:

Biocompatibility testing: "TheraCal LC was tested for biocompatibility and it was found to be non-toxic."
Physical and chemical property testing: The summary mentions chemical composition and mechanical/physical properties (low viscosity, dispensable composite) being similar to the predicate. This would involve laboratory tests to measure these properties, though specific results or test methods are not detailed.

The core of the "study" is to demonstrate substantial equivalence to an already legally marketed device by showing similar intended use, technological characteristics, and performance, including safety (biocompatibility). The document effectively states that the device meets the acceptance criteria (especially non-toxicity and similarity to the predicate), but it does not provide the detailed quantitative data or methodologies one would expect for an AI diagnostic device's validation.

Summary

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K 063237

Page 5-1

Section 5 510 (k) SUMMARY

Applicant:	Bisco, Inc.
	1100 W. Irving Park Road
	Schaumburg IL, 60193
Contact Person:	Benjamin Lichtenwalner
	Tel: 847-534-6146
	Fax: 847-534-6111
Date Prepared:	October 25, 2006
Trade Name:	TheraCal LC
Common Name:	Liner & Pulp Capping Material
Classification/Name:	Liner, Cavity, Calcium Hydroxide
	Class II per 21 CFR 872.3250

DEC - 8 2006### Description of Applicant Device:

Intended uses of Applicant Device:

Predicate Devices: Prisma VLC Dycal cleared under (K922721) dated July 23, 1992.

	Prisma VLC Dycal	TheraCal LC
Intended use	Liner & Pulp Capping Material	Liner & Pulp Capping Material
Chemical composite	Light-cured, Calcium Hydroxidefilled, resin liner	Light-cured, MTA (MineralTrioxide Aggregate) filled, resinliner
Mechanical /physicalproperties	Low viscosity, dispensablecomposite	Low viscosity, dispensablecomposite

Significant Performance Characteristics:

Side by side comparisons of TheraCal LC to the predicate device Prisma VLC Dycal clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. TheraCal LC was tested for biocompatibility and it was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TheraCal LC.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC - 8 2006

Re: K063237

Trade/Device Name: TheraCal LC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: October 25, 2006 Received: October 26, 2006

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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Benjamin Lichtenwalner

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sujata Y. Michlen DMD.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

and we will be and the country of the count

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16663757 510 (k) Number (if known):

TheraCal LC Device Name:

Indications for Use:

1. Liner
1. Pulp capping agent

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

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)

Susan Rumor

(Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

0632337

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.