The Ecusit Composite Repair material is a single-component, methyl methacrylate-based, light-curing bonding agent specifically developed for use in intra-oral repair of poor or damaged dental composite restorations.

AI/ML Overview

Here's an analysis of the provided text regarding the Ecusit Composite Repair device, focusing on acceptance criteria and study details.

Based on the provided K992879 document, the submission is a 510(k) Pre-Market Notification for a dental device, Ecusit Composite Repair. These types of submissions typically rely on substantial equivalence to a predicate device rather than extensive human clinical trials with strict acceptance criteria for AI or diagnostic accuracy as seen in medical imaging or diagnostic tests.

Therefore, many of the requested points regarding AI performance metrics (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of device and submission.

The "acceptance criteria" for a 510(k) for a device like this revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons of materials, design, and performance characteristics, often involving bench testing.

Here's a breakdown of the information that is applicable:

Acceptance Criteria and Device Performance for Ecusit Composite Repair

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Material Composition and Design (Equivalent to predicate device in foundational properties)	The materials, performance specifications, and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices (One Coat Bond Dentin/Enamel Adhesive System, K974906).
Biocompatibility/Safety (No new safety concerns compared to predicate)	The device is deemed "safe and effective for its intended use" based on substantial equivalence and performance testing, implying no new safety concerns.
Performance Characteristics (Equivalent mechanical/bonding properties)	"Shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material," suggesting these metrics were comparable and acceptable relative to the predicate.
Intended Use (Matches predicate)	"Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations," matching the scope of predicate devices.

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

Sample Size for Test Set: Not specified in the provided document. The performance data mentioned (shear strength, composite penetration depth) would have been generated from laboratory bench tests on material samples, not human subjects.
Data Provenance: Not specified, but generally, for dental material testing, this would be laboratory-generated data by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not Applicable. For a dental material like this, "ground truth" is established through standardized laboratory testing protocols (e.g., ISO standards for dental materials) rather than expert consensus on diagnostic images or clinical outcomes. The "experts" would be materials scientists and engineers conducting the tests.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple human readers, not for bench testing of material properties.

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

No. An MRMC study is not relevant for this type of device. There is no human-in-the-loop diagnostic interpretation involved that would necessitate such a study.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not an AI/algorithm-based diagnostic device. Performance is inherent to the material properties.

7. The Type of Ground Truth Used

Laboratory Bench Test Results. The "ground truth" for the performance evaluation of this material would be objective measurements from laboratory tests, such as:
- Shear bond strength measurements (e.g., in MPa).
- Composite penetration depth measurements (e.g., in micrometers).
- Material characterization (e.g., chemical composition, physical properties).

8. The Sample Size for the Training Set

Not Applicable. This device does not involve an AI algorithm with a distinct "training set."

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

Not Applicable. As there is no AI algorithm, there is no training set and therefore no ground truth establishment for it.

Summary of the Study Proving Acceptance:

The "study" proving the device meets acceptance criteria for a 510(k) submission like this is primarily bench testing and a detailed comparison of material specifications and performance characteristics against a legally marketed predicate device.

The document states:

"Substantial equivalence for this device was based on similarities in design and performance characteristics as well as performance testing."
"The materials, performance specifications and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices."
"In addition, shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material."

This indicates that internal laboratory testing data (shear strength, composite penetration depth) was generated for the Ecusit Composite Repair. This data, along with a comprehensive comparison of its chemical composition, physical properties, and intended use, was then used to demonstrate that it performed equivalently to the predicate device (One Coat Bond Dentin/Enamel Adhesive System, K974906). The FDA's clearance signifies their agreement that this evidence was sufficient to establish substantial equivalence, thereby deeming the device "safe and effective for its intended use."

Summary

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K992879

NOV - 9 1999

510(k) Summarv

Trade Name:	Ecusit Composite Repair
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901Registration # not yet assigned
Device Generic Name:	Resin tooth bonding agent
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.

The proposed Ecusit Composite Repair is substantially equivalent Predicate Devices: to the One Coat Bond Dentin/Enamel Adhesive System marketed by Coltene/Whaledent, Inc., which was cleared for marketing by FDA in K974906.

Product Description:

Indications for Use:

Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations.

Safety and Performance:

Substantial equivalence for this device was based on similarities in design and performance characteristics as well as performance testing. The materials, performance specifications and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices. In addition, shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Ecusit Composite Repair has been shown to be safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 1999

DMG USA, Incorporated c/o Ms. Pamela Papineau Consultant to DMG USA, Incorporated Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, MA 01432

K992879 Re : Ecusit Composite Repair Trade Name: Regulatory Class: I Product Code: KLE Dated: Auqust 16, 1999 Received: Auqust 26, 1999

Dear Ms. Papineau:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Papineau

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 regulations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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

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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Page 1 of

510(k) Number (if known): _K 9 92879

Device Name: Ecusit Composite Repair

Indications for Use:

Ecusit Composite Repair is indicated for intra-oral repair of composite restorations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the -Counter Use __

Susan Ruanu
(Division Sign-Off)
Division of Dental, Infection Control,

and General Hospital I

510(k) Number

900010

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.