COMPOGLASS F by IVOCLAR NORTH AMERICA, INC.

The provided text describes a 510(k) premarket notification for a device named "Compoglass F," indicating that the FDA has determined it to be substantially equivalent to a legally marketed predicate device. This type of regulatory document typically focuses on demonstrating equivalence rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics as might be found in a De Novo or PMA submission.

Therefore, many of the requested details about acceptance criteria, specific study design elements (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), and reported device performance are not available in the provided text. The document is primarily a regulatory approval letter based on demonstrating substantial equivalence, not a summary of a clinical trial proving specific performance against predefined acceptance criteria.

However, based on the context, we can infer some limited information:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly stated in the provided document. The letter indicates that the device "Compoglass F" is substantially equivalent to predicate devices for specific "Indications For Use." Substantial equivalence typically means the device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially that it is deemed safe and effective enough to be on the market, as demonstrated by its equivalence to existing marketed devices.

Indications For Use (which implicitly define the scope of acceptable performance):

Acceptance Criteria (Implicit by Indication)	Reported Device Performance
Effective for restorations in deciduous teeth	Deemed substantially equivalent to predicate devices for this use.
Effective for Class V restorations (cervical caries, root erosion, wedge-shaped defects)	Deemed substantially equivalent to predicate devices for this use.
Effective for Class III restorations	Deemed substantially equivalent to predicate devices for this use.
Effective for intermediate Class I and II restorations	Deemed substantially equivalent to predicate devices for this use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available in the provided text. A 510(k) submission might include bench testing, and potentially some limited clinical data, but the letter itself does not specify these details.

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):

Not applicable/Not available. The concept of "ground truth" established by experts for a test set is typically associated with performance studies, often for diagnostic AI devices. This document is for a dental restorative material, likely relying on established material properties, biocompatibility, and clinical performance data that existed for the predicate device(s) or standard dental practices.

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

Not applicable/Not available. See point 3.

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:

Not applicable. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of imaging. This device is a dental restorative material.

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

Not applicable. This device is a dental material, not an AI algorithm.

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

For a material like "Compoglass F," the "ground truth" equivalent would likely be:

Biocompatibility: Established through standard ISO or ASTM tests.
Physical and Mechanical Properties: Measured against established dental material standards (e.g., strength, wear resistance, fluoride release).
Clinical Performance (historically): The performance of the predicate devices would serve as the benchmark for safety and effectiveness in the stated indications. This would likely be supported by clinical data or long-standing clinical practice.

This information is not provided in the document, but these are typical "ground truths" for such devices.

8. The sample size for the training set:

Not applicable/Not available. The concept of a "training set" in the context of machine learning is not relevant for this type of device and regulatory submission.

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

Not applicable/Not available. See point 8.

Summary

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Federal Aviation Administration

JUN - 3 1997

Food and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter P. Mancuso 'Ouality Assurance/Requlatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

K971513 Re : Compoglass F Trade Name: Requlatory Class: II Product Code: EBF Dated: April 18, 1997 April 28, 1997 Received:

Dear Mr. Mancuso:

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, Drug, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 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.

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Page 2 - Mr. Mancuso

This letter will allow you to beqin 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), please contact the Office of Compliance at (301) 594-4618. 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 at (301) 443-6597.

Sincerely yours,

Timothy H. White, chair

Time y 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 1

510(k) Number (if known):

Compoglass F Device Name:

Indications For Use:

Restorations in deciduous teeth -
Class V restorations (cervical caries, root erosion, wedge-shaped defects) -
Class III restorations -
-Intermediate Class I and II restorations

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital 510(k) Number

Prescription Use (Per 21 CFR 801 1109)

Over-The-Counter Use No

(Optional Format 1-2-96)

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.