The Portable HDX Intraoral X-ray unit is intended for use only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.

Device Description

Portable HDX Intraoral X-ray is a portable dental x-ray system that operates on 120 VAC (+/-10%), 60 Hz, and 240 VAC (+/-10%), 50 Hz line AC power. The system uses Constant Emission Power (CEP) which allows for minimum exposure time and can be either mounted to a tripod or can be hand held.

AI/ML Overview

The "Portable HDX Intraoral X-ray" device is a portable dental x-ray system. The study for this device primarily focuses on demonstrating substantial equivalence to a predicate device (MinXray HF70D) rather than meeting specific performance criteria through a standalone study. The acceptance criteria and testing are based on regulatory and government performance standards for X-ray systems.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criterion	Portable HDX Intraoral X-ray (Reported Performance)	Predicate Device (MinXray HF70D)
Intended Use	Extraoral dental x-ray with intraoral receptors (for adult and pediatric subjects)	SAME
Energy Source	120V 50 Hz or 240V Hz AC	120V 50-60 Hz AC
Size (Body)	5.5" H x 8.25 W x 8" D	5.8" H x 4.8" W x 7.9" D
Size (Cone)	2.75" Dia. x 5.75" L	2" Dia. x 6" L
Weight	11.7 lbs.	10.4 lbs.
User Interface	Up-down buttons for exposure time selections with display.	Up-Down pushbuttons for three kVp selections and exposure time selection with indicators.
Exposure Times	0.01 – 2.00 seconds in 0.01 increments	0.02 - 1.98 seconds in 99 steps
mA	7 mA	10 mA
kVp	65 kVp	60, 65, 70 kVp
Performance Standard	21 CFR 1020.30, United States Government Specifications SP0200-96-R-8076 (NSN 6525-01-425-5216)	21 CFR 1020.30
Electrical Safety	UL 2601, CSA 601-M90, EN 6061-1:1990+A1+A2	UL 2601, IEC 6061-1

The acceptance criteria are implicitly defined by compliance with the listed performance standards and demonstration of comparable performance to the predicate device across various technical specifications. The reported device performance is presented as its specifications, which are compared to those of the predicate device. The conclusion is that the new system is "as safe and effective" as the predicate based on bench and user testing against these standards.

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

The document states that "bench and user testing" was performed. However, the specific sample sizes for the test set (e.g., number of tests, number of users, number of images) are not provided. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified, beyond mentioning "bench and user testing" against US government specifications.

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

This information is not provided in the document. The study design described does not involve a ground truth established by experts in the typical sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, it relies on compliance with engineering and safety standards for the device itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. The testing described is against performance standards and specifications, not an assessment of diagnostic performance requiring adjudication of interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-powered diagnostic tool, so evaluation of human reader improvement with AI assistance is not relevant to this filing.

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

A standalone performance evaluation of an "algorithm only" (without human-in-the-loop performance) was not done. This device is a hardware system; there is no mention of an algorithm being evaluated in this context. The standalone performance evaluation referred to here would be the device's adherence to relevant technical standards (e.g., radiation output, exposure accuracy), which was indeed assessed through "bench and user testing."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" in the diagnostic accuracy sense (like pathology or expert consensus for image interpretation) is not directly applicable to this submission. The "ground truth" or reference standard used here is the adherence to established technical performance and safety standards for X-ray devices, specifically 21 CFR § 1020.30 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components) and United States Government Specifications SP0200-96-R-8076. These standards define acceptable parameters for the physical operation and safety of the X-ray system.

8. The Sample Size for the Training Set

A "training set" is not applicable to this type of device. The Portable HDX Intraoral X-ray is a physical medical device, not an AI/machine learning model that requires a training set.

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

This question is not applicable as there is no training set for this device.

Summary

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K021378

Image /page/0/Picture/1 description: The image shows the logo for DentalEZ Group. The logo consists of the word "DentalEZ" in a bold, sans-serif font. Below the "EZ" portion of the word, the word "GROUP" is written in a smaller font. A curved line extends from the bottom of the "G" in "GROUP" and wraps around the right side of the logo.

7 2002 JUN

Star Dental Products 1816 Colonial Village Lane Lancaster, PA 17601-5864 717/291-1161 Fax 717/391-2757 www.dentalez.com

510(k) SUMMARY

Portable HDX Intraoral X-ray April 29, 2002

1. Company: StarDental®, Division of DentalEZ® Owner/operator number 2520265
  Contact Person: Deon Beck Manufacturing Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, PA 17601 717-291-1161 Telephone: Facsimile: 717-391-2757
1. Proprietary-Trade Name: Portable HDX Intraoral X-ray Classification Name: Extraoral source x-ray system (per 21 CFR section 872.1800) Portable Dental X-ray Common/Usual Name:
1. Predicate Devices:

MinXray HF70D (K000061) Literature is included at Tab 4.

4. Description:

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5. Intended Use:

Portable HDX Intraoral X-ray is to be used only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors. The usual safety precautions regarding the use of x-rays must be observed by the operator.

6. Safety and Effectiveness, comparison to predicate device:

The result of bench and user testing per Performance Standards 21 CFR § 1020.30 and United States Government Specifications SP0200-96-R-8076 (NSN 6525-01-425-5216) indicates that the new system is as safe and effective as the predicate devices.

Feature	Portable HDX Intraoral X-ray	MinXray HF70D
Intended Use:	Extraoral dental x-ray w/intraoralreceptors	SAME
Energy Source:	120V 50 Hz or 240V Hz AC	120V 50-60 Hz AC
Size:	Body: 5.5" H x 8.25 W x 8" DCone: 2.75" Dia. x 5.75" L	Body: 5.8" H x 4.8" W x 7.9" DCone: 2" Dia. x 6" L
Weight:	11.7 lbs.	10.4 lbs.
User Interface:	Up-down buttons for exposure timeselections with display.	Up-Down pushbuttons for threekVp selections and exposure timeselection with indicators.
Exposure Times:	0.01 -- 2.00 seconds in 0.01 increments	0.02 - 1.98 seconds in 99 steps
mA:	7 mA	10 mA
kVp:	65 kVp	60, 65, 70 kVp
Performance Standard:	21 CFR 1020.30,United States Government SpecificationsSP0200-96-R-8076 (NSN 6525-01-425-5216)	21 CFR 1020.30
Electrical Safety:	UL 2601, CSA 601-M90,EN 6061-1:1990+A1+A2	UL 2601, IEC 6061-1

7. Substantial Equivalence Chart:

Image /page/1/Picture/6 description: The image shows the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font. To the right of the text is a stylized star symbol, which is partially filled in with black.

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8. Conclusion:

After analyzing all testing data and meeting performance standards and specifications it is the conclusion of DentalEZ that the "Portable HDX Intraoral X-ray" is as safe and effective as the predicate device. The system has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

Image /page/2/Picture/2 description: The image contains the text "StarDental" in a bold, sans-serif font. To the right of the text is a stylized graphic that resembles a star or an abstract geometric shape. The overall impression is that of a logo for a dental company named StarDental.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures in profile, with their heads overlapping to create a sense of unity and connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Deon Beck Manufacturing Engineer Dental EZ Group Star Dental Products 1816 Colonial Village Lane LANCASTER PA 17601-5864 Re: K021378

7 2002

JUN

Trade/Device Name: Portable HDX Intraoral X-ray system Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 76 EHD Dated: April 29, 2002 Received: May 1, 2002

Dear Mr. Beck:

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 Intended Use:

The Portable HDX Intraoral X-ray unit is intended for use only by a qualified/trained Fire Formore HD7P maderal 12 cm) adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.

Prescription Use

David A. Sygnyn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K021378 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.