The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital sensors or film.

Device Description

The DexcoWinA ADX4000 Cordless Portable Dental X-ray System is a battery-powered hand-held dental x-ray machine whose fixed output is 60 k Vo (Constant Potential). It can be used with either a digital sensor or conventional film. This is a prescription device that can be used on pediatric and adult patients.

AI/ML Overview

This document is a 510(k) summary for the DexcoWinA ADX4000 Cordless Portable Dental X-ray System. It describes the device and claims substantial equivalence to a predicate device. This type of document typically focuses on comparing the new device's specifications to a previously cleared device, rather than providing a detailed clinical study demonstrating the new device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission relies on demonstrating that the new device is "substantially equivalent" to an existing, legally marketed device, meaning it has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device's technical specifications and intended use are substantially equivalent to a predicate device (NOMAD™ Dental X-ray System). The table provided compares features and specifications of the new device (DexcoWinA ADX4000) against the predicate device (NOMAD™):

Feature	Acceptance Criteria (Implicitly, the Predicate Device's performance/specifications)	Reported Device Performance (DexcoWinA ADX4000)
Intended Use	The NOMAD™ Dental X-ray System is indicated for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce X-ray images using intraoral image receptors.	The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors. (Substantially Equivalent)
Size: Body	13"L x 11.5"H x 5.5"W	5.5"H x 6.5"W x 3.2"D
Weight	8.5 lbs	4.4 lbs
Source to skin distance	20cm	20cm (Matches)
Cone diameter	6cm	5cm
Exposure Time	0.01-0.99 seconds in 0.01 increments	0.01-1.35 seconds in 0.01 increments
Timer Accuracy	± (10%+1ms)	± (10% + 1ms) (Matches)
mA	2.3mA fixed	1mA fixed
kVp	60kVp fixed	60kVp fixed (Matches)
Waveform	Constant Potential (DC)	Constant Potential (DC) (Matches)
Duty Cycle	1:60	1:60 (Matches)
Electrical Safety Standards	IEC60601-1 & others.	IEC60601-1 & others (Matches)
Electromagnetic Standards	IEC60601-1-2	EN60601-1-2 & others (Functionally Equivalent)
X-RAY PERFORMANCE	21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7	21 CFR 1020.30, 1020.31, IEC60601-1-3 (Functionally Equivalent)

The "acceptance criteria" here are implicitly that the new device's technical specifications and regulatory compliance meet or are substantially equivalent to those of the predicate device, or fall within acceptable industry standards for dental X-ray systems.

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

This information is not provided in the document. This is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence through technical comparisons and adherence to standards, rather than extensive clinical testing with patient data.

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)

This information is not provided. As noted above, a clinical study with a test set and expert-established ground truth is not detailed in this 510(k) submission.

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

This information is not provided.

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

This information is not provided. The device is an X-ray system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

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

This information is not applicable. The device is a physical X-ray system, not an algorithm.

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

This information is not provided as there is no mention of a clinical study with a defined ground truth. The "ground truth" for this submission is effectively the established performance and safety profile of the predicate device and adherence to relevant national and international standards for X-ray devices.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not provided as it's not relevant to this type of device and submission.

Summary

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K070811.st

510(k) Summary

031

DexcoWinA ADX4000 Cordless Portable Dental X-ray System

Common/Classification Name:

JUL - 5 2007

Unit, X-Ray, Extraoral With Timer

21 CFR 872.1800

Sponsor:

Dexco Attn: Henry Jang, Vice-President 1102, 31d E&C Venture Dream Tower 197-33 Guo-dong, Guro-gu Seoul (South) Korea

Contact:

RegTech Solutions, LLC; Attn: Robert Mazzaferro, Manager 11 Dellcastle Court; Montgomery Village, MD 20886

Prepared: March 20, 2007

LEGALLY MARKETED PREDICATE DEVICE

For its indication for use, the DexcoWinA ADX4000 Cordless Portable Dental X-ray System is substantially equivalent to the Nomad Dental X-ray System cleared by FDA under K051795.

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE SUMMARY

A comparison of the Dexco WinA ADX4000 Cordless Portable Dental X-ray System and the Nomad™ Dental X-ray System is presented in Table 1.

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Feature	DexcoWinA ADX4000 (New Device)	NOMAD™ (Predicate Device K051795)
INTENDED USE:	The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors.	The NOMAD Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subject as an extraoral diagnostic dental x-ray sources to produce X-ray images using intraoral image receptors.
MECHNICAL:
Size: Body	5.5"H x 6.5"W x 3.2"D	13"L x 11.5"H x 5.5"W
Weight	4.4lbs.	8.5lbs
Source to skin distance	20cm	20cm
Cone diameter	5cm	6cm
User Interface	Up-down and left-right buttons for exposure time selections with display	Up-down buttons for exposure time selections, with timer display
Backscatter radiation protection	Circular scatter shield	6.75"dia. Pb-filled acrylic plastic scatter shield
Exposure switch	On tubehead assembly, or at control panel	On tubehead assembly/ control panel
Tubehead mounting	Handheld, or on a tripod	Handheld
ELECTRICAL:
Energy Source	Rechargeable 16.8V DC Li-Polymer battery pack	Rechargeable 14.4V DC NiCd battery pack
Exposure Time	0.01-1.35 seconds in 0.01 increments	0.01-0.99 seconds in 0.01 increments
Timer Accuracy	$\pm$ (10% + 1ms)	$\pm$ (10%+1ms)
mA	1mA fixed	2.3mA fixed
kVp	60kVp fixed	60kVp fixed
Waveform	Constant Potential (DC)	Constant Potential (DC)
Duty Cycle	1:60	1:60
Electrical Safety Standards	IEC60601-1 & others	IEC60601-1 & others.
Electromagnetic Standards	EN60601-1-2 & others	IEC60601-1-2
X-RAY PERFORMANCE	21 CFR 1020.30, 1020.31IEC60601-1-3	21 CFR 1020.30, 1020.31IEC60601-1-3IEC60601-2-7

CONCLUSION

As can be seen in the comparison table above the DexcoWinA ADX4000 & its suggested predicate, the Nomad, have the same intended use and are nearly technically the same. We therefore believe that the ADX4000 is substantially equivalent to the Nomad.

. 032

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Image /page/2/Picture/0 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure with three arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL - 5 2007

DexcoWinA % Mr. Robert Mazzaferro Manager RegTech Solutions, LLC 11 Dellcastle Court MONTGOMERY VILLAGE MD 20886

Re: K070811

Trade/Device Name: ADX4000 Cordless Portable Dental X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 18, 2007 Received: June 18, 2007

Dear Mr. Mazzafferro:

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 commence 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 movi. therefore, market the device, subject to the general controls provisions of the Act. The grateral 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 the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters FDA in a bold, stylized font. The text is slightly blurred, suggesting it may be part of a larger document or image.

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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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/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

510(k) Number (if known):

K070811

AND/OR

Device Name: ADX4000 Cordless Portable Dental X-ray System

Indications for Use: The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and bediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital sensors or film.

× Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1.

Helena Lewin
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 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.