The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.

Device Description

Digital dental Intraoral Xray sensor

AI/ML Overview

The provided text is a 510(k) summary for the Apex HRI Digital Radiography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance. As such, much of the requested information regarding acceptance criteria, specific performance metrics, and study details is not available in the provided document.

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or a formal study demonstrating the device meets these criteria in terms of image quality or diagnostic accuracy. Instead, the entire submission is based on the premise of substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not Explicitly Stated)	Device Performance (Inferred from Substantial Equivalence)
Image Acquisition: Produce intraoral diagnostic X-ray images.	Device is used to take dental intraoral diagnostic x-rays, detecting emitted radiation and transmitting data for grayscale image display.
Safety: Device operates safely within dental practice settings.	Implied by substantial equivalence to predicate devices, subject to general controls provisions of the Act (21 CFR Part 807, 801, 820) and electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
Functionality: Replacement for standard intraoral X-ray film and chemicals.	Designed to replace standard intraoral X-ray film and film development chemicals.
Technological Characteristics: Similar to predicate devices in key aspects.	"Identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product... virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials."
Intended Use: Used for dental intraoral diagnostic X-rays.	Stated intended use matches predicate devices.

Study Details (Based on Substantial Equivalence Claim)

The document does not describe a specific clinical study undertaken to establish the device's performance against predefined acceptance criteria. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.

Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of an independent performance study is described. The comparison is against predicate devices based on their established characteristics and intended use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No independent ground truth establishment for a test set is described.
Adjudication method for the test set: Not applicable. No "test set" and corresponding adjudication process are 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 an intraoral digital X-ray sensor, not an AI-assisted diagnostic tool for which MRMC studies assessing reader improvement would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a digital X-ray sensor, which is a hardware component with associated imaging software, not an algorithm, and intrinsically involves a human operator (dentist/radiographer) in its use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an independent performance study. The "ground truth" for the substantial equivalence claim is the performance and regulatory acceptance of the predicate devices.
The sample size for the training set: Not applicable. The device is a digital X-ray sensor; it does not explicitly describe an algorithm that requires a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable, for the same reasons as point 7.

Summary of the K023292 Submission:

The K023292 submission for the Apex HRI Digital Radiography System is a 510(k) Premarket Notification. This regulatory pathway is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and the same technological characteristics, or, if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness.

The core of this submission is the statement: "The Apex HRI Digital Radiography sensor is identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product... The Apex HRI Digital Radiography sensor is virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials. The only difference between these and the Computed Oral Radiology System is the type of sensor employed... This is a minor difference in design. All four products are used in exactly the same manner and circumstances."

Therefore, the "proof" that the device meets acceptance criteria is the argument that it is the same or substantially similar to devices already accepted as safe and effective by the FDA. The submission does not detail independent studies with new performance data.

Summary

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igman Technologies. In

September 24, 2002

DEC 1 3 2002

510 (k) Summary

K023292

Submitter Information:

Krugman Technologies, Inc. 1000 Hart Road Suite 180 Barrington, IL 60010 Phone: (800) 506-9736 (847) 381-9940 Fax: Email: admin@ktinet.net

Name of Device:

Trade Name: Apex HRI Digital Radiography System Common Name: Intraoral Digital Xray sensor Classification Name: Unit, Xray, Intraoral (per 21 CFR Section 892.1800) This is a Class II device MUH

Product Code:

Substantially Equivalent Devices:

Trophy Radiologie RVG Portable Radiovisiography K950532 Mediadent HDXMMD HDX SP xray sensor K002425 Computed Oral Radiology System K933455

Device Description:

Digital dental Intraoral Xray sensor

Intended Use:

This device is used to take dental intraoral diagnostic xrays

Technological Characteristics compared to predicate devices:

The Apex HRI Digital Radiography sensor is identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product manufacturer for the Apex and Mediadent devices is Fimet Oy. The Apex HRI Digital Radiography sensor is virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials. The only difference between these and the Computed Oral Radiology System is the type of sensor employed. The Computed Oral Radiolology System uses a CMOS sensor while Apex, Mediadent and Trophy use a CCD sensor. This is a minor difference in design. All four products are used in exactly the same manner and circumstances. All four use the same barrier protection for infection control as well.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 13 2002

Mr. Michael A. Krugman President Krugman Technologies, Inc. 1000 Hart Road. Suite 180 BARRINGTON IL 60010

Re: K023292 Trade/Device Name: Apex HRI Digital Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: September 24, 2002 Received: October 2, 2002

Dear Mr. Krugman:

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/dsmaldsmamain.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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Krugman Technologies, Inc.

September 24, 2002

Indication for Use

510 (k) Number: KO23292 Device Name: Apex HRI Digital Radiography System

The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.

The Apex HRI Digital Xray Sensor is covered with a sterile disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to xray. The dental xray tube (which is NOT part of this product) is pointed at the sensor and activated.

The emitted radiation from the xray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. The inaging software interprets the data stream and displays it as a grey scale image on the monitor of the connected computer system. The grey scale image is the digitally formed xray the dentist will then use for diagnostics.

David A. Dunn

on Sign-Off) of Reproductive, Ab ominal diclogical Devic : Xky Number

Prescription Use

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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.