The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the DENTAMERICA KOGOGAO 510(k) Summary, focusing on acceptance criteria and study data:

Based on the provided document, the DENTAMERICA Digirex™ Digital Dental Radiography System does not include information on specific acceptance criteria or a study that proves the device meets those criteria.

This 510(k) summary is for a device that was found substantially equivalent to predicate devices. The focus of this type of submission is typically on demonstrating that the new device has the same technological characteristics and intended use as existing, legally marketed devices. It does not primarily involve studies to prove performance against specified acceptance criteria in the same way a novel, higher-risk device submission might.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not provided in this document.

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

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in terms of quantitative metrics or performance against pre-defined criteria. The document states its function ("A digital sensor rather than film is used to capture x-rays... and produce digital images...") and its benefits ("images appear instantaneously," "much smaller dose of x-ray radiation").
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document does not describe a performance study with a test set.
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, as no ground truth establishment for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no test set adjudication is described.
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. The device is a digital radiography system, not an AI-assisted diagnostic tool. No MRMC or human reader improvement studies are mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a digital imaging capture system, not an algorithm that performs diagnostic analysis independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no ground truth for performance evaluation is described.
The sample size for the training set
- Not applicable. This type of device (digital X-ray sensor) does not typically involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established
- Not applicable.

Summary of the K060640 Filing:

The DENTAMERICA Digirex™ Digital Dental Radiography System's 510(k) summary focuses on demonstrating "Substantial Equivalence" to legally marketed predicate devices (RSV Radiology System Visiodent - K031448, EVA Digital Dental X-Ray System - K030647, Visualix Radiographic Image Detecting and Process - K925094).

The core argument for substantial equivalence is based on:

Intended Use: Replacing traditional film-based dental x-ray imaging to capture and produce digital images of a patient's mouth for analysis, archiving, and electronic transmission.
Technological Characteristics: Utilizing a digital sensor to capture x-rays from an external source and a USB controller to transfer images to a computer, which is the same method used by the predicate devices.
Benefits: Instantaneous image display and reduced x-ray radiation dose for the patient, which are inherent benefits of digital radiography over film.

The FDA's review concluded that the device is substantially equivalent, allowing it to be marketed under the general controls provisions of the Act. This type of clearance typically relies on comparing the new device's specifications and functionality to those of already cleared devices, rather than requiring extensive de novo performance studies with defined acceptance criteria and statistical proof.

Summary

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DENTAMERICA

KOGOGAO 510(k) Summary

APR 2 4 2006

Submission Date: February 20, 2006

Submitter's Information: Dentamerica Inc. 0 18320 Bedford Circle Industry, CA 91744

Contact Person: Eric Huang, (Product Manager) Phone: 626-912-1388 Fax: 626-913-0510

Establishment Registration Number: 2024949

Trade Name: Digirex™ Common Name: Digital Dental Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: 90 EHD

Performance Standard: None established under section 514 Reason for 510(k): New finished device Special controls: No applicable mandatory performance standards or special controls exist for this device.

Substantially Equivalent Legally Marketed Devices (predicates):

RSV (Radiology System Visiodent) Device - K031448 EVA Digital Dental X-Ray System - K030647 Visualix Radiographic Image Detecting and Process - K925094

Intended Use and Device Description:

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DENTAMERICA

Technological Characteristics and Substantial Equivalence:

The Digirex™ Digital Dental Radiography System has a number of substantially equivalent (SE) predicate devices. These predicate devices use the same technological methods to perform the task of digital image capture from an external x-ray source. A digital sensor and USB controller are the main components of the predicate devices.

Digital dental radiography eliminates the need for conventional film to produce images from an external x-ray source. The benefits of this are two-fold. First, images appear instantaneously. There is no longer a need for a dark room and chemicals to process the undeveloped x-ray film. Second, and more importantly, is that a much smaller dose of x-ray radiation is required to produce an image, benefiting the patient.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the eagle. The eagle is depicted with stylized lines, giving it a modern and symbolic appearance. The overall design is simple, clean, and conveys a sense of authority and professionalism.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 2 4 2006

Mr. Eric Huang Product Manager Dentamerica, Inc. 18320 Bedford Circle INDUSTRY CA 91744

Re: K060640

Trade/Device Name: Digirex™ Digital Dental Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Il Product Code: EHD Dated: February 20. 2006 Received: March 10, 2006

Dear Mr. Huang:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in an elegant, cursive font. The logo commemorates the centennial of the FDA, highlighting its role in protecting and promoting public health.

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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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours,

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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Indications for Use

Kobob40 510(k) Number (if known):

Device Name: Digirex™ Digital Dental Radiography System

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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

Harvey Burton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 060640 510(k) Number

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.