The NOMAD Pro X-ray System is intended to be used by trained dentists and dental technicians as an extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The NOMAD Pro X-ray System is indicated for use only 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 Xray images using intraoral image receptors.

Device Description

NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NOMAD Pro Handheld X-ray System, based on the provided text:

Important Note: The provided text is a 510(k) Summary and FDA acceptance letter. It focuses on demonstrating substantial equivalence to predicate devices and does not contain details of a clinical study with acceptance criteria and a detailed performance report in the way a clinical trial report would. Instead, it relies on comparisons of technical specifications and performance against regulatory standards and existing devices to establish safety and effectiveness. Therefore, some sections you requested will be marked as "Not provided in text" or inferred from the regulatory context.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally met by demonstrating that the new device has the same intended use as a legally marketed predicate device and has similar technological characteristics, or if different, that these differences do not raise new questions of safety or effectiveness. The document effectively uses the predicate device as its benchmark for acceptable performance.

Feature / Acceptance Criteria Category	Reported Device Performance (NOMAD Pro)
Intended Use	Extraoral X-ray source for diagnostic imaging using intraoral image receptors by trained dentists/dental technicians, for adult & pediatric subjects (Same as predicate)
Mechanical Characteristics
Size (L x H x W)	10.5"L x 12"H (including shield) x 5.25"W
Weight	5.3 lbs
Source to skin distance	21 cm
Cone diameter	6 cm
User Interface	Up-down buttons for exposure time selection, with timer display. Also, user-selectable preset times with patient size, image-receptor type, and tooth selection icons on an LCD display.
Backscatter radiation protection	6.75" dia. Pb-filled acrylic plastic scatter shield
Exposure switch	Trigger on Handset
Tubehead mounting	Handheld
Electrical Characteristics
Energy Source	Rechargeable 22.2 V DC Lithium Polymer battery pack
Exposure Time	0.02 – 1.00 seconds in 0.01 increments
Timer Accuracy	±(10% + 1ms)
mA (current)	2.5 mA fixed
kVp (voltage)	60 kVp fixed
Waveform	Constant Potential (DC)
Duty Cycle	1:60
Electrical Safety Standards	IEC60601-1, EN60601-1
EMI Standards	EN60601-1-2
X-Ray Performance Standards	21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7 (Meets these standards)

Study Details

The provided document describes a premarket notification (510(k)), which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting results from a standalone clinical study that would establish specific performance metrics against pre-defined acceptance criteria. The "study" here is primarily a comparison and adherence to regulatory standards.

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of the provided 510(k) summary. This document does not describe a clinical "test set" of patient data in the sense of a diagnostic performance study. The evaluation is based on technical specifications, engineering tests demonstrating compliance with standards, and comparison to predicate devices.
- Data Provenance: Not applicable. The "data" here refers to the device's technical specifications and compliance with international and US standards, rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no "test set" with ground truth from experts is described in this regulatory submission. Expert evaluation would be part of the design and testing process internally, but not detailed as a separate component of the 510(k) summary for external review.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as there is no described test set requiring expert adjudication.
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:
- No MRMC study was done. This device is an X-ray source, not an AI-powered diagnostic tool, so reader improvement with AI assistance is not relevant to its function.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical X-ray device. Its standalone performance is assessed by meeting physical, electrical, and radiation safety standards, which were presumably tested by the manufacturer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is adherence to established engineering, electrical, and radiation safety standards (e.g., IEC60601-1, EN60601-1-2, 21 CFR 1020.30, 1020.31) and demonstrating that its performance characteristics are comparable to legally marketed predicate devices. No clinical "ground truth" from patient data is described in this document.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. There is no training set.

Summary

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K081664
pg. 1 of 2

Tab 4

510(k) Summary

JUN 2 3 2008

NOMAD Pro Handheld X-ray System 30 May 2008

1. Company:

Name:	Aribex, Inc.
Address:	744 South 400 EastOrem, UT 84651

Official Correspondent: D. Clark Turner, PhD, CEO

Telephone No: 801-226-5522 801-434-7233 FAX No:

2. Proprietary - Trade Name:	NOMAD Pro X-ray System
Classification Name:	Extraoral source X-ray system (per 21CFR section 872.1800)
Common/Usual Name:	Handheld Dental X-ray System

Predicate Device: Port-X II Portable X-ray System, 510(k) # K0063121, manufactured by Genorav, and the NOMAD Dental X-ray System, 510(k) #K051795. manufactured by Aribex. Literature included at Tab 12.

1. Description: NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.
1. Intended Use: The NOMAD Pro X-ray System is intended to be used by trained dentists and dental technicians as an extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

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K081664
pg. 2 of 2

5. Comparison with predicate devices:

Feature	Genoray Port-X IIK063121	NOMAD DentalIntraoral X-ray SourceK051795	NOMAD ProIntraoral X-ray Source
INTENDED USE:	All three systems are intended as extraoral X-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
MECHANICAL:
Size: Body	7.8" x 5.8" x 3.7"	13"L x 11.5"H x 5.5"W	10.5"L x 12"H (including shield) x 5.25"W
Weight	5.2 lbs	8.5 lbs.	5.3 lbs.
Source to skin distance	10 cm	20 cm	21 cm
Cone diameter	7 cm	6 cm	6 cm
User Interface	Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size and tooth selection icons on an LCD display.	Up-down buttons for exposure time selection, with timer display.	Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size, image-receptor type, and tooth selection icons on an LCD display.
Backscatter radiation protection	None	6.75" dia. Pb-filled acrylic plastic scatter shield	6.75" dia. Pb-filled acrylic plastic scatter shield
Exposure switch	Exposure button at x-ray control panel	Trigger on tubehead assembly and Start button on control panel	Trigger on Handset
Tubehead mounting	Handheld, or on a tripod	Handheld	Handheld
ELECTRICAL:
Energy Source	Rechargeable 22.2 V DC Lithium Polymer battery pack	Rechargeable 14.4 V DC NiCd battery pack	Rechargeable 22.2 V DC Lithium Polymer battery pack
Exposure Time	0.01 – 2.0 seconds in 46 steps	0.01 – 0.99 seconds in 0.01 increments	0.02 – 1.00 seconds in 0.01 increments
Timer Accuracy	±(10% + 1ms)	±(10% + 1ms)	±(10% + 1ms)
mA	2 mA fixed	2.3 mA fixed	2.5 mA fixed
kVp	60 kV fixed	60 kVp fixed	60 kVp fixed
Waveform	Constant Potential (DC)	Constant Potential (DC)	Constant Potential (DC)
Duty Cycle	(not available)	1:60	1:60
Electrical Safety Standards	EN60601-1	IEC60601-1, UL60601-1, EN60601-1	IEC60601-1, EN60601-1
EMI Standards	EN60601-1-2	IEC60601-1-2	EN60601-1-2
X-RAY PERFORMANCE:
Performance Standard	EN60601-1-3EN60601-2-7EN60601-2-28EN60601-2-32	21 CFR 1020.30, 1020.31IEC60601-1-3IEC60601-2-7	21 CFR 1020.30, 1020.31IEC60601-1-3IEC60601-2-7

1. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Aribex, Inc. concludes that the NOMAD Pro Portable X-ray System is safe and effective and substantially equivalent to predicate devices as described herein.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2008

Aribex, Inc. c/o Mr. Morten Simon Christensen Staff Engineer/Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230

Re: K081664

Trade/Device Name: NOMAD Pro X-ray System Regulation Number: 21 CFR 8872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: June 10, 2008 Received: June 13, 2008

Dear Mr. Christensen:

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, 1796, 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 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.

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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 complics 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.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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Tab 3

Indications For Use

K. 081664 510(k) Number:

Device Name: NOMAD Pro X-ray System

Indications for Use: The NOMAD Pro X-ray System is indicated for use only 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 Xray images using intraoral image receptors.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vorzu M. Whan

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

Prescription Use X
(per 21CFR801.109)

Over-The-Counter Use

Page 6 of 69

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.