The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.

Device Description

The JADE Mobile X-Ray, is a mobile x-ray device that comes in two models: JADE-32 (3.2kw max. output and JADE-40 (4kw max. output). JADE is a non-motorized mobile diagnostic xray device that can facilitate X-ray examinations, in situations where it is not possible or feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device.

The JADE device consists of:

. High-Frequency X-ray Generator
Collimator with 30 seconds LED lamp timer
User Programmable APR
. Exposure Hand Switch
. Software(SDK, HT Frame and Membrane Console Firmware)

AI/ML Overview

The provided text describes the JADE Mobile X-Ray device and its substantial equivalence to a predicate device (AMADEO M-DR Mini, AMADEO M-AX Mini). However, it does not contain information about specific acceptance criteria related to a device's performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a study designed to prove the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics of the JADE Mobile X-Ray to those of the predicate device and by listing compliance with various safety and EMC standards. It explicitly states:

"Clinical testing is not necessary for the JADE Mobile system in order to demonstrate substantial equivalence to the predicate device."
"Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

This indicates that the "acceptance criteria" referred to are likely related to engineering specifications, safety standards compliance, and functional validation of the device's components and software, rather than performance metrics derived from a clinical or diagnostic accuracy study.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets performance-based acceptance criteria (like sensitivity/specificity), as such a study is explicitly stated as not necessary and not included in this 510(k) summary.

Here's what can be extracted based on the provided text regarding the non-clinical testing and general acceptance:

A table of acceptance criteria and the reported device performance:
As mentioned, no performance-based acceptance criteria (like sensitivity, specificity, or accuracy for image interpretation) are stated in the document. The "acceptance criteria" refer to compliance with various international standards and functional validation of the device's components. Since these are pass/fail assessments against engineering and safety standards, a quantitative "reported device performance" in the context of clinical metrics is not applicable here.

Acceptance Criterion Type	Reported Device Performance
Safety Standards (e.g., IEC/EN 60601 series)	Passed all predetermined testing criteria; complies with applicable regulatory requirements and design standards.
EMC Standards (e.g., EN60601-1-2)	Passed all predetermined testing criteria; complies with applicable regulatory requirements and design standards.
Functional Validation (input/output, actions)	Validation testing indicated that predetermined acceptance criteria were met.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable (N/A). The document refers to non-clinical testing of the device hardware and software against engineering and safety standards, not a test set of patient data.
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):
N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy, which was explicitly stated as not necessary for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A.
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:
N/A. This is a primary X-ray device, not an AI-assisted diagnostic tool for image interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
N/A.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
N/A. For engineering and safety tests, the "ground truth" would be the specifications and requirements of the applicable standards.
The sample size for the training set:
N/A. The "software" components mentioned (JADE_HTC, JADE_MCC, CPC_SDK) appear to be firmware and control software for the X-ray generator, not an AI or machine learning model that would require a "training set" of data in the typical sense.
How the ground truth for the training set was established:
N/A.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DRGEM Corporation % Mr. Carl Alletto Consultant OTech. Inc. 8317 Belew Drive MCKINNEY TEXAS 75071 February 5, 2019

Re: K183388

Trade/Device Name: JADE Mobile X-Ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 1, 2018 Received: December 14, 2018

Dear Mr. Alletto:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183388

Device Name JADE Mobile X-Ray

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

510(k) number: K183388

Date Prepared:

December 1, 2018

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Ki-Nam YANG Director | QM representative DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Product Name:	JADE Mobile X-Ray
Common Name:	Mobile X-Ray System
Classification:	System, X-Ray, Mobile
Regulation Number:	892.1720
Product Code:	IZL
Device Classification:	Class II

Predicate Device: 21 CFR 807. 92(a)(3)

The JADE Mobile X-Ray, device is substantially equivalent to K182317:

Device Classification Name	System, X-Ray, Mobile
510(K) Number	K182317
Device Name	AMADEO M-DR Mini, AMADEO M-AX Mini
Applicant	OEHM UND REHBEIN GMBH
Regulation Number	892.1720
Device Classification	Class II
Classification Product Code	IZL
Subsequent Product Code	MQB
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Radiology
510k Review Panel	Radiology
Summary	Summary
Type	Traditional

Device Description: 21 CFR 807 92(a)(4)

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feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device.

"Caution" The JADE Mobile X-ray should not be used as a handheld device.

The JADE device consists of:

. High-Frequency X-ray Generator
Collimator with 30 seconds LED lamp timer
User Programmable APR
. Exposure Hand Switch
. Software(SDK, HT Frame and Membrane Console Firmware)

No.	PESS	Processor	Description
1	JADE	JADE_HTC	JADE_HTC at HT control board in x-ray generator controls whole x-ray generationprocess by the control of System Control Module in CPC_SDK. This modulecontrols x-ray parameters such as kV, mA and exposure time, and controls thefilament and detector interfacing.
		JADE_MCC	JADE_MCC at console board in control console consist of generator controlmodule. JADE_MCC display the state of X-ray parameter and generator.
2	CPC	CPC_SDK	CPC_SDK is the software provides user interface on generator control. CPC_SDKconsists of generator control Module and Display Module, System DiagnosisModule

. Optional equipment:
- o Remote Controller (to control the Collimator Lamp, X-ray Exposure)
- Portable Stand o
- Mobile Stand O

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

Technological Characteristics: 21 CFR 807 92(a)(6)

. JADE Mobile X-ray specifications are in TABLE 1.
TABLE 2 is the collimator specifications and
TABLE 3, compares the predicate device and the new device. Any differences . between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.

TABLE 1 Mobile X-Ray Unit Specs

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Model	JADE-32	JADE-40
Input Power	100 - 240V~ (Free voltage input),50/60Hz	110 - 240V~ (Free voltage input),50/60Hz
Output Rating	Max. 3.2 kW (40mA@80kV,32mA@100kV, 25mA@120kV)	Max. 4 kW (50mA@80kV,40mA@100kV, 32mA@120kV)
Type	Microprocessor controlled High Frequency inverter
KV Range	40 ~ 120 KV, 81Step (1KV Step)
mA Range	10 ~ 80 mA, 10Step (10, 12.5, 16,20, 25, 32, 40, 50, 64, 80mA)	10 ~ 100 mA, 11Step (10, 12.5, 16,20, 25, 32, 40, 50, 64, 80, 100mA)
Exposure Time	0.01 ~ 10 seconds, 21Step (in 25% Steps)
mAs Range	0.1 ~ 250 mAs, 35Step (in 25% Steps)
X-ray Tube Type	Stationary Anode
Focal Spot Size (Small / Large)	0.5 / 1.5 mm
Anode Heat Storage Capacity	56,000HU (40,000 J)
Power Cord Length	5 m
Exposure Hand-switch Cord Length	5 m (Max. Length)
X-ray switching frequency	100 kHz
Control	2 Point Control (kV, mAs)
Control Display	LED (7-seg display & indicators)
Anatomical Programs	Preprogrammed 9 APR data - User Programmable
External Interface	USB, Bluetooth (Option), DR Interface (Option)
Max. Input PowerRating	25 A @ 240 V~, 35 A @ 100 V~	24 A @ 240 V~, 34 A @ 110 V~
Weight	16.8kg (37lb) (Including Collimator)

TABLE 2 - Collimator Specs

Model	KM1
Manufacturer	DRGEM
Control	Manual with 15, 30, 45, 60sec. Lamp timer
Field Shape	Rectangular
Max. Field Size	44x44cm (at 100cm SID)
Leakage Radiation	< 40mR/hr. (at SID 1m)
Max. kVp shield	150kV
Inherent Filtration	2.0mmAl eq.
Luminosity	Over 160LUX at 100cm SID
Light source	19W LED
Standard	Rotating flange
Option	Tape measure (Max. 200cm)
Electrical Rating	12 - 45VDC, 20W

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Dimension / Weight	172(W) x 172(D) x 97(H) mm / 2.5kg(5.5lb)
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TABLE 3 – Predicate and Subject Device Comparison

The following information compares the subject device to the predicate. Any differences are due between the subject device and the predicated device has no impact on safety or efficacy of the modified device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed device.

Characteristic	Subject Device	Predicate K182317, AMADEO M-DR Mini, AMADEO M-AX Mini
Indications forUse	The JADE Mobile X-Ray, is amobile X-ray device, for thepurpose of acquiring X-ray imagesof the desired parts of a patient'sanatomy. This device is notintended for mammography, bonedensity, or dedicated pediatricapplications.	They Portable DiagnosticRadiographic System are intendedfor use by a qualified/trained doctoror technician on both adult andpediatric subjects for takingdiagnostic radiographic exposuresof the skull, spinal column, chest,abdomen, extremities, and otherbody parts. Applications can beperformed with the patient sitting,standing, or lying in the prone orsupine position. (Not formammography).
Configuration	Same as predicate	Line operated portable
Generator	High frequency made by DRGEM	High frequency made by POSKOM
Generatorpower	Two power levels: JADE-32(3.2kw max. output and JADE-40(4kw max. output).	One power level: 5 KW
Peak Voltage	120kv	110kv
Collimator	DRGEM Corporation (Model KM1)	POSKOM PCMAX-100CAH

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Characteristic	Subject Device	Predicate K182317, AMADEO M-DR Mini, AMADEO M-AX Mini
Imageacquisition	None	None or Either the PerkinElmerXRpad2 4336 detector as cleared inK161966 or the XenOR 35CW(CareRay CareView1500CW)cleared in K150929 (our modelXenOR 35CW)
Software	DRGEM SDK	DICOMPACS DX-R
Connections	USB, RS232 or Wi-Fi	Ethernet or Wi-Fi
DICOM	None	Yes
ElectricalSafety	Same	Electrical Safety per IEC-60601.EMC per IEC-60601-1-2; IEC60601-1-3 Radiation protection indiagnostic X-ray equipment IEC60601-2-54 ParticularRequirements for The Basic SafetyAnd Essential Performance of X-RayEquipment for Radiography andRadioscopy
Image: X-Ray machine	Image: X-Ray machine	Image: X-Ray machine

Clinical Testing:

Clinical testing is not necessary for the JADE Mobile system in order to demonstrate substantial equivalence to the predicate device.

Nonclinical Testing:

The complete system has been assessed and tested at the factory and by Standards testing facilities. The JADE Mobile X-Ray, device has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by JADE, and followed the process documented in the System Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

The main components of JADE Mobile X-ray, comply with the applicable regulatory requirements and design standards as follows:

1) SAFETY

IEC/EN 60601-1 3.1 Edition .

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. EN 60601-1:2006/A1:2013 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
EN 60601-1-3:2008/A1:2013. Medical electrical equipment -- Part 1-3: General . requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
. EN 60601-1-6:2010/A1:2015. Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
EN 60601-2-54:2009, Medical electrical equipment -- Part 2-54: Particular . requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
EN 60601-2-28:2010, Medical electrical equipment -- Part 2-28: Particular . requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

EN60601-1-2:2015, Medical electrical equipment Part 1-2: General requirements for . safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN55011:2009/A1:2010, CISPR 11 :2009/A1:2010 ●
EN 61000-3-2:2014, Electromagnetic compatibility (EMC) -- Part 3-2: Limits Limits Limits -● for harmonic current emissions (equipment input current <= 16 A per phase)
. EN61000-4-2:2009, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
. EN61000-4-3:2006/A1:2007/A2:2010. Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
. EN61000-4-4:2012, Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
. EN61000-4-5:201, Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test
. EN61000-4-6:2014. Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radiofrequency fields
EN61000-4-8:2010, Electromagnetic compatibility (EMC) Part 4-8: Testing and . measurement techniques - Power frequency magnetic field immunity test
. EN61000-4-11:2004, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests

OTHERS

EN ISO 15223-1:2016, Medical devices Symbols to be used with medical device ● labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
IEC TR60878:2003, Graphical Symbols for electrical equipment in medical practice ●
IEC60417-1:2000, Graphical Symbols for use on equipment-part1 : overview and application
. ISO 14971: 2012, Medical devices - Application of risk management to medical devices (ISO 14971:2012)

The 510(k) Pre-Market Notification for the JADE Mobile X-Ray, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and

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intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, the JADE Mobile X-Ray, device, is substantially equivalent to the predicate 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.