These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).

Device Description

The AMADEO M-DR mini Portable X-Ray is a fully digital X-ray system for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The AMADEO M-DR mini is used for wireless digital X-ray imaging. The device represents the straightforward combination of 510(k) exempt devices (x-ray generator, code IZO and collimator, code IZX) and already cleared digital panels and imaging software. Two different models of digital image acquisition panels are offered: PerkinElmer XRpad2 4336 or CareView 1500CW. Both of the panels and the associated software have been previously cleared by FDA (K161966 or K150929). Integration with the portable system was straightforward.

AI/ML Overview

The provided text is a 510(k) summary for the AMADEO M-DR mini and AMADEO M-AX mini mobile X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance or clinical studies.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not present in this document.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a table of formal acceptance criteria with numerical performance targets for the device. Instead, it asserts equivalence to the predicate device based on meeting recognized standards and similar characteristics.

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Intended Use	SAME as predicate device
Configuration	SAME as predicate device
Performance Standard	Adheres to 21 CFR 1020.30 (SAME as predicate)
Electrical Safety & EMC	Complies with IEC-60601, IEC-60601-1-2, IEC 60601-1-3, IEC 60601-2-54 (SAME as predicate)
Generator Power Level	One power level: 5 KW (Predicate has 4 KW, 8 KW)
Peak Voltage	110 kV (Predicate has 125 kV)
Image Acquisition	Uses previously cleared PerkinElmer XRpad2 4336 or XenOR 35CW (CareView1500CW) detectors (Predicate uses Toshiba FDX3543RP or FDX3543RPW)
Digital Panel Resolution	XRpad2 4336: 100 μ, 3524 × 4288 pixels; XenOR 35CW: 154 μ 2304 x 2816 pixels (Predicate has 143 μ 2448 ×2984 pixels or 140 μ, 2466 ×3040 pixels)
Software	DICOMPACS DX-R (Predicate uses eCom software)
Total System Functionality	Confirmed through test images
Risk Analysis	Performed

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document mentions "test images" were obtained, but no specific number of images or patients is provided.
Data Provenance: Not specified. As clinical testing was not required, there is no mention of country of origin or whether data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Since the submission states clinical testing was "Not required because the proposed digital panels have prior FDA clearance," it implies that new ground truth establishment by experts for image interpretation was not part of this specific submission.

4. Adjudication method for the test set:

Not applicable, as no formal clinical test set or adjudication by experts is described.

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:

Not applicable. This submission is for a mobile X-ray system, not an AI-powered diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed or mentioned.

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

Not applicable. This device is an imaging system, not a standalone algorithm.

7. The type of ground truth used:

The concept of "ground truth" in the context of diagnostic accuracy from expert consensus or pathology is not directly applicable to this submission. The "ground truth" for this device's performance relies on its ability to produce diagnostic radiographic exposures that are comparable to those of the predicate device and meet established safety and performance standards. This is evaluated through:

Compliance with DHHS Radiation Safety Performance Standard.
Compliance with electrical safety and EMC standards (IEC-60601 series).
Test images demonstrating total system functionality.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Oehm Und Rehbein Gmbh % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114

September 24, 2018

Re: K182317

Trade/Device Name: AMADEO M-DR mini, AMADEO M-AX mini Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: August 17, 2018 Received: August 27, 2018

Dear Daniel Kamm:

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 (OS) 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 A. 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) K182317

Device Name Amadeo M-DR mini; Amadeo M-AX mini

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for OR Technology. The logo consists of a grid of four squares on the left, with the bottom left square being blue and containing a smiley face. To the right of the squares is the text "OR Technology" in a blue sans-serif font, followed by the text "Digital X-ray and Imaging Solutions" in a smaller font.

Oehm und Rehbein GmbH Neptunallee 7c 18057 Rostock GERMANY Phone: (49) 381 36 600 500 (49) 381 36 600 555 Fax: Date Prepared: September 21, 2018 Prepared by: Franziska Günther Email: franziska.quenther@or-technology.com 510(k) Summary for K182317

1. Identification of the Device:

Trade/Device Names: Amadeo M-DR mini; Amadeo M-AX mini Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Mobile Diagnostic X-Ray System

2. Equivalent legally marketed device: K173299

Trade/Device Name: DRAGON X SPSL4HC; DRAGON X SPSL8HC Manufacturer: Sedecal SA Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Mobile Diagnostic X-Ray System

3. Reference legally marketed devices (Digital Panels) K161966 OR K150929

Trade/Device Names: XRpad2 4336 HWC-M OR CareView 1500CW Manufacturer: PerkinElmer, Inc. OR Careray Digital Medical System CO., LTD. Regulation Number: 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Common/Usual Name: Digital X-Ray Receptor Panel

1. Indications for Use (intended use) These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
1. Description of the Device: The AMADEO M-DR mini Portable X-Ray is a fully digital X-ray system for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The AMADEO M-DR mini is used for wireless digital X-ray imaging. The device represents the straightforward combination of 510(k) exempt devices (x-ray generator, code

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IZO and collimator, code IZX) and already cleared digital panels and imaging software. Two different models of digital image acquisition panels are offered: PerkinElmer XRpad2 4336 or CareView 1500CW. Both of the panels and the associated software have been previously cleared by FDA (K161966 or K150929). Integration with the portable system was straightforward. The device complies with the US Federal Safety Performance Standard and was safety tested by MET Labs. The key differences between the new device and the predicate device are as follows: Manufacturer of the generator and the digital panels and the accompanying software are different. The similarities and differences are compared in the Substantial Equivalence Chart below.

1. Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and risk management evaluations indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.

Characteristic	SEDECAL DRAGON X SPSL4HC;DRAGON X SPSL8HC K173299	Amadeo M-DR mini; (with digitalimaging)Amadeo M-AX mini (without digitalimaging)
Intended Use:	These Portable DiagnosticRadiographic Systems are intendedfor use by a qualified/trained doctoror technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull,spinal column, chest, abdomen,extremities, and other body parts.Applications can be performed withthe patient sitting, standing, or lying inthe prone or supine position. (Not formammography).	SAME
Configuration	Line operated portable	SAME
PerformanceStandard	21 CFR 1020.30	SAME
Generator	High frequency made by Sedecal	High frequency made by POSKOM
Generator powerlevel	Two available power levels:4 KW, 8 KW	One power level: 5 KW
Peak voltage	125 kV	110 kV
Collimator	Ralco R72S	POSKOM PCMAX-100CAH
Imageacquisition	Toshiba FDX3543RP orFDX3543RPW as cleared in K130883	Either the PerkinElmer XRpad2 4336detector as cleared in K161966 orthe XenOR 35CW (CareRayCareView1500CW) cleared in K150929(our model XenOR 35CW)
Characteristic	SEDECAL DRAGON X SPSL4HC;DRAGON X SPSL8HC K173299	Amadeo M-DR mini; (with digitalimaging)Amadeo M-AX mini (without digitalimaging)
Digital PanelSpecifications	FDX3543RP: 143 μ 2448 ×2984pixels or:FDX3543RPW: 140 μ, 2466 ×3040pixels	XRpad2 4336: 100 μ, 3524 × 4288pixels or:XenOR 35CW (CareView1500CW):154 μ 2304 x 2816 pixels
Software	eCom software as cleared in K130883	DICOMPACS DX-R
Connection	Ethernet or Wi-Fi	SAME
DICOM	YES	YES
Power Source	AC Line	SAME
Electrical safetyand EMC	Electrical Safety per IEC-60601. ULlisted; EMC per IEC-60601-1-2;IEC 60601-1-3 Radiation protection indiagnostic X-ray equipmentIEC 60601-2-54 ParticularRequirements For The Basic SafetyAnd Essential Performance Of X-RayEquipment for Radiography andRadioscopy	SAME (MET Listed)
Standards (Otherthan Electricaland EMC)	Wi-Fi 802.11b/g and:FCC Rules and Regulations 47 CFRChapter I Part 15 Subpart B; Part 18Subpart C ICES-003 ISSUE 5 (2012) &ICES-001 ISSUE 4 (2014) & ANSI C63.4-2009.; US PERFORMANCE STANDARDFOR X-RAY	SAME
Photos	Image: SEDECAL DRAGON X SPSL4HC	Image: Amadeo M-DR mini

7. Substantial Equivalence Chart

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1. Summary of Laboratory Testing and Bench Testing: Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. A risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hipot testing, generator testing, including generator controls (voltage, current, timing), and image acquisition.
1. Summary of Clinical Testing: Not required because the proposed digital panels have prior FDA clearance.
1. Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Oehm und Rehbein GmbH that the new AMADEO M-DR Portable X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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.