The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician or dentist diagnosis. The ADC Dental is intended to be used in extraoral dental and maxillofacial imaging applications.

Device Description

The ADC Compact Plus, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.

The ADC Dental is identical in hardware and software to the ADC Compact Plus. The only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure Rather than entering the exposure parameters by exam type. parameters manually, as would be the case for dental/maxillofacial exams using the ADC Compact Plus, the user would simply select the exam type and patient age, and the proper image processing parameters would be selected automatically and applied to "developing" the image.

AI/ML Overview

Here's an analysis of the provided text regarding the ADC Dental device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria were not explicitly defined, nor were precise quantitative performance metrics reported. The submission focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Provide diagnostic quality images to aid in physician and dentist diagnosis.	"found to be preferred to traditional imaging techniques."
Intended for use in extraoral dental and maxillofacial imaging applications.	Indicated for and intended to be used in these applications.
Substantially equivalent to predicate devices (ADC Compact Plus and Schick Technologies CDR-Pan Model 4700).	"The ADC Dental is identical in hardware and software to the ADC Compact Plus." "The only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure." "The ADC Dental has the same (identical) technological characteristics as the predicate device."

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

Sample Size: Not specified. The document only mentions "a clinical environment."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not specified.
Qualifications: "physician and dentist." Specific qualifications (e.g., number of years of experience, specialization) are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. The document states, "The ADC Dental was tested in a clinical environment and it was found to be preferred to traditional imaging techniques." This is a general statement, not indicative of a formal MRMC study with a comparative effectiveness analysis of human readers with vs. without AI assistance. The device itself is a digital imaging system, not an AI-assisted diagnostic tool in the modern sense.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done? No. The device is an imaging system, not an algorithm meant for standalone diagnosis. Its function is to produce images for human interpretation. The "only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure ... the user would simply select the exam type and patient age, and the proper image processing parameters would be selected automatically and applied to 'developing' the image." This describes automated image processing, not a diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Implied to be based on expert preference ("found to be preferred to traditional imaging techniques") for "diagnostic quality images." It does not explicitly state pathology confirmation or direct outcomes data.

8. Sample Size for the Training Set

Sample Size: Not applicable. The device is a computed radiography system, not a machine learning model that requires a training set in the conventional sense. The "data file" mentioned for image processing parameters would likely be based on expert knowledge and empirical testing rather than an algorithmic training process on a large dataset.

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

Ground Truth Establishment: Not applicable. As mentioned above, there isn't a "training set" in the context of an AI/ML model for this device. The image processing parameters in the data file would have been established through expert-defined settings and optimization for dental/maxillofacial imaging, likely drawing on established radiographic principles and empirical adjustments.

Summary

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510(k) Summary

ADC Dental

K021542

Common/Classification Name: Computed Radiography, 21 CFR 892.1630

Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048

Contact: Jeff Jedlicka, Prepared: May 8, 2002

LEGALLY MARKETED PREDICATE DEVICES A.

The predicate device is the previous version of the same device, namely the ADC Compact Plus, which was cleared by FDA on 28 September 2001 as K013138. For the indications for use of acquiring digital dental/maxillofacial radiographic images, the ADC Dental is substantially equivalent to the Schick Technologies CDR-Pan Model 4700, which was cleared for marketing by FDA on December 11, 1998 as K982661.

DEVICE DESCRIPTION B.

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C. INTENDED USE

Koli542-

The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician and dentist diagnosis. The ADC Dental is intended to be used in extraoral dental and maxillofacial imaging applications.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The ADC Dental has similar indications for use as the legally marketed predicate devices. The differences do not affect the intended diagnostic effect. The ADC Dental has the same (identical) technological characteristics as the predicate device. This premarket notification has described the characteristics of the ADC Dental in sufficient detail to assure substantial equivalence.

ட். TECHNOLOGICAL CHARACTERISTICS

The technological characteristics are identical in the proposed and predicate devices.

F. TESTING

The ADC Dental was tested in a clinical environment and it was found to be preferred to traditional imaging techniques.

CONCLUSIONS G.

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's commitment to health, human services, and well-being. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

AUG 0 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeff Jedlicka Manager of Regulatory Affairs and Compliance Agfa Corporation 10 South Academy Street GREENSVILLE SC 29602

Re: K021542 Trade/Device Name: ADC Dental Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: May 9, 2001 Received: May 10, 2002

Dear Mr. Jedlicka:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): KO21542

Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

David A. Seymour

and Ra 510k) Ne

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.