EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic x-ray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above.

It is not intended to replace a radiographic system with variable tube current and voltage (KVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

Device Description

EZER Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kVp) in order to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head. X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates extremities and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric patients.

The embedded 7" TFT display in EZER Portable X-ray is not intended to be used for diagnosis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EZER Portable X-ray System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it describes a subjective comparison study against a predicate device. The primary "acceptance criterion" appears to be demonstrating similar overall quality to the predicate device.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality	Similar overall quality compared to the predicate device (NOMAD MD Handheld X-ray System)	Images taken from EZER have similar quality overall compared with Nomad MD. Images from EZER show no other radiographic abnormalities or issues with diagnostic images.
Safety - Operators/Patients	Conformance to relevant safety standards and guidance documents (IEC, EN, CFR standards)	Testing performed successfully according to relevant standards; Device development utilized "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use" and "The Content of Premarket Submissions for Software Contained in Medical Devices" guidance documents.
Intended Use	Meeting the stated Indications for Use (diagnostic x-ray images of extremities for adults and pediatrics age 2+)	Confirmed as suitable for its intended use and user instruction.

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

Sample Size: Not explicitly stated in terms of number of images or cases. The document mentions "Images taken from the predicate and subject devices were reviewed." This implies a set of images was used, but the quantity is not specified.
Data Provenance: Not explicitly stated. The study details do not mention the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: One (1) expert.
Qualifications: An American board-certified radiologist. No specific number of years of experience is provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Only a single expert reviewed and rated the images, so there was no multi-reader consensus or adjudication process described. The expert directly compared and rated the images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. Only a single radiologist performed the image comparison.
Effect Size: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. The EZER Portable X-ray System is an X-ray imaging device, not an AI algorithm. The study described is an evaluation of the image output generated by the device, which is then interpreted by a human expert. The device does include an embedded display for reference, but it's explicitly stated "not intended to be used for diagnosis."

7. The Type of Ground Truth Used

Type of Ground Truth: "Expert comparison/rating." The ground truth was established by a single American board-certified radiologist who reviewed and rated images from both the subject device and the predicate device. This is a form of subjective expert evaluation.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The EZER Portable X-ray System is a hardware device (X-ray system) and not an AI or machine learning algorithm that requires a training set in the typical sense.

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

Training Set Ground Truth: Not applicable, as the device is not an AI/ML system requiring a training set with established ground truth.

Summary

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May 7, 2020

Livermoretech, Inc. % Mr. Dave Kim Regulatory Affairs Mtech Group 7707 Fannin Street. Suite 200 HOUSTON TX 77054

Re: K193535

Trade/Device Name: EZER, Portable X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: April 17, 2020 Received: April 17, 2020

Dear Mr. Kim:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193535

Device Name EZER Portable X-ray System

Indications for Use (Describe)

EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic xray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K193535

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

April 29, 2020 Date 510k summary prepared:

I. SUBMITTER

Submitter's Name	Livermoretech
Submitter's Address	801 North Jupiter Rd, Suite 200Plano TX 75074
Submitter's Telephone
Contact person	Jay Kim (jay.kim@aspenstate.com) / RA ManagerTel: +1-214-257-0113
Official Correspondent	Dave Kim (davekim@mtech-inc.net)
Address	7707 Fannin St. Ste 200, V111, Houston, TX 77054
Telephone	+713-467-2607

II. DEVICE

Trade/proprietary Name	EZER Portable X-ray System
Regulation Name	Mobile X-ray System
Regulation Number	21 CFR 892.1720
Product Code	IZL
Regulatory Class	Class II

III. PREDICATE DEVICE

510K Number	K140723
Manufacturer	Aribex, Inc
Device Name	NOMAD MD Handheld X-ray System
Regulation Name	Mobile X-ray System
Regulation Number	21 CFR 892.1720
Product Code	IZL
Regulatory Class	Class II

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IV. DEVICE DESCRIPTION:

The embedded 7" TFT display in EZER Portable X-ray is not intended to be used for diagnosis.

Indications for Use: 21 CFR 807 92 (a) (5) V.

It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

Comparison Table with the Predicate Device for technological characteristics:

Feature	Nomad MDX-ray System (K140723)	EZER Portable X-ray System(K193535)
Regulation No.	21 CFR 892.1720	21 CFR 892.1720
Regulation Class	II	II
Product Code	IZL	IZL
Indications forUse/IntendedUse:	The NOMAD MD is a handheld and portablegeneral purpose X-ray system. The deviceuses a fixed tube current and voltage (kVp)and, therefore, is limited to takingdiagnostic X-rays of extremities.It is intended to be used by a qualified andtrained clinician on both adult and pediatricpatients. It is not intended to replace aradiographic system with variable tubecurrent and voltage (kVp) which may berequired for full optimization of imagequality and radiation exposure fordifferent exam types.	EZER Portable X-Ray system is a portable x-ray source with a fixed tube current andvoltage for producing diagnostic x-rayimages of extremities using digital or filmimage receptors. Its use is intended to beused by trained clinician or technicians forboth adult and pediatric subjects age 2 andabove.It is not intended to replace a radiographicsystem with variable tube current andvoltage (kVp) which may be required forfull optimization of image quality andradiation exposure for

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LIVERMORETECH

801 North JupiterRd, Suite 200, Plano, TX 70574 USA

Tel.: +214-257-0113

		different exam types.
Principle of Operation	General Purpose Diagnostic X-Ray	General Purpose Diagnostic X Ray
TECHNOLOGICAL:
Size: Body	9.5"H x 5.25"Wx10"L(excluding Source Skin guard)	9.2" L x 6.4"W x 4.6" H
Weight	11.0 lbs.	5.7 lbs (2.6 kg)
Source to skin distance	30 cm	30 cm
Focal Spot	0.4 mm	1.2 mm
Collimator	Four manually and steplesslyadjustable shutters with LED LightField Center Indicator	Four manually and steplesslyadjustable shutters with light beamtype central x-ray indicator (AdvantechR72)
Triggering Mechanism	Two stage triggering	Two stage triggering
User Interface	Up-down buttons for exposure timeselection, with timer display.	Up-down push buttons for kVpselections and exposure time selectionswith LED indicators and mAs indicators.
Energy Source	Rechargeable 14.4 V DC NiCd battery pack	Rechargeable 22.2 V DCLithium Ion Polymer battery pack
Exposure Time	0.02 – 0.99 seconds in 0.01 increments	0.03~1.30 seconds in 0.01 increments
mA	2.0 mA fixed	2.0 mA fixed
kVp	75 kVp fixed	60 kVp fixed

VI. Discussion of differences

The subject device is similar to the predicate device in terms of the indications for use and technological application. Both the subject and predicate devices are portable X-ray system for taking diagnostic X-rays of human anatomy using a fixed tube current and voltage (kVp). The subject device has on board computer and a display screen that allows the doctor to view X-ray images for reference purpose only and not for diagnosis. Other differences include device design such as battery pack, exposure time, size and user interface.

VII. Non clinical testing

Testing was performed successfully according to the following standards:

IEC 60601-1-3:2008+A1:2013
EN 60601-1-2:2015
≫ IEC 62133:2012
EN 62133:2013
EN 60601-1:2006/A1:2013
IEC 60601-2-54:2009 (First edition),A1:2014 for use in conjunction with IEC 60601-1:2015 (third e dition) A1:2012

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Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients: "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use" "The Content of Premarket Submissions for Software Contained in Medical Devices"

The device also conforms to the following:

21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products

21 CFR 1020.30: Diagnostic x-ray system and their major components

21 CFR 1020.31: Radiographic Equipment

VIII. Summary of Clinical Tests

Images taken from the predicate and subject devices were reviewed and rated in comparison by an American board-certified radiologist.

Based on image comparison test and data analysis, images taken from EZER, the subject device, have similar quality overall compared with Nomad MD, the predicate device. Based on images taken from EZER, there are no other radiographic abnormalities and any issue with diagnostic images.

IX. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table, the EZER Portable X-ray System has little difference with its size and user interface as the information in the table. The subject device is substantially equivalent to the predicate device with its intended use, mechanical and electrical performance as described.

Performance evaluation (test) reports and device inspection report confirmed that the EZER Portable X-ray System suitable for its intended use and user instruction of the device.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.