This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: HF120/60H PowerPlus cleared in K040046, (and in K141885) OR HF100H+ cleared in K052721 OR HF1202 PowerPlus cleared in K153059. One of three cleared digital X-ray receptor panels: Toshiba FDX3543RP OR the Toshiba FDX3543RPW cleared in K162687 (and others) OR the PerkinElmer Solid State Imager, (K140551) PLUS: the dicomPACS® software package (K141885) (Same as our predicate). The X-ray generators are portable units which operate from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the formerly used Toshiba panels or PerkinElmer flat panel technology in a sleek and compact unit. The portable panels provide digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the digital x-ray receptor panel.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a diagnostic medical device evaluating patient data for specific clinical endpoints.

Instead, the document is a 510(k) premarket notification for a mobile X-ray system, which is a piece of medical imaging equipment. The "acceptance criteria" and "study" described herein relate to demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the performance of a diagnostic algorithm against a clinical ground truth.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document doesn't present a formal table of acceptance criteria for a diagnostic performance study. Instead, it focuses on demonstrating that the new devices have similar technological characteristics and performance to the predicate device, and that they produce images of "diagnostic quality."

Characteristic/Test	Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	As safe and effective as the predicate devices (K141885).	"The results of bench testing indicates that the new devices are as safe and effective as the predicate devices."
Proper System Operation	Proper function and diagnostic quality similar to the predicate generator/panel combination.	"We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination." "Several test exposures showed that the system was operating properly."
Image Quality (Phantom Study)	Images obtained from newly configured systems should be of "diagnostic quality" when compared to the predicate using a standardized test device.	"We employed the i.b.a. Test Device DIGI-13... to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested. The images were evaluated and found to be of diagnostic quality."
Compliance with Regulations/Standards	Compliance with DHHS radiation safety standards, UL 60601-1 (2005), IEC 60601-1-2 (2007), and IEC 60601-2-54 (for one generator model).	"The completed system complies with DHHS radiation safety standards currently in effect, and has undergone testing for compliance with UL 60601-1 (2005) (Electrical medical device safety), IEC 60601-1-2 (2007) (Electromagnetic Compatibility). Additionally, the HF1202H PowerPlus generator meets IEC 60601-2-54..."
Risk Mitigation (FMEA)	Identification and successful mitigation of risks and hazardous conditions from device modification.	"The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted."
Software Compatibility (new digital panel)	dicomPACS® software must be compatible with the new PerkinElmer digital panel.	"The software supplier Oehm Und Rehbein GmbH verified compatibility with the new PerkinElmer digital panel and supplied us with a test report."

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

Test Set Description: The "test set" in this context refers to prototype systems and phantom images, not a clinical image dataset with patient outcomes.
Sample Size: "Prototype systems covering all generator/panel combinations were assembled and tested." "Several test exposures showed that the system was operating properly." "All panel/generator combinations were tested" with the DIGI-13 device. The exact number of exposures or phantom images is not specified beyond "several" and "all combinations."
Data Provenance: This was bench testing performed internally by MinXray, Inc. The data is entirely synthetic (phantom images) and technical system performance data, not patient data from a specific country or for retrospective/prospective analysis.

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

Number of Experts: Not specified. The evaluation of "diagnostic quality" from the phantom images was an internal assessment.
Qualifications of Experts: Not specified. It's implied that the evaluation was done by the manufacturer's personnel, likely engineers or qualified technicians, as part of the system testing. There is no mention of external radiologists or clinicians establishing ground truth for these technical images.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. There was no multi-reader or consensus-based adjudication in a clinical diagnostic sense. The evaluation was a technical assessment of image quality and functionality against established safety and performance standards for X-ray equipment.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a mobile X-ray system, not an AI-powered diagnostic tool.
Effect Size of AI Assistance: Not applicable, as no AI component or human-in-the-loop diagnostic performance was evaluated.

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

Standalone Performance: Not applicable. This device is a hardware system for acquiring X-ray images, not a standalone diagnostic algorithm.

7. The type of ground truth used:

Type of Ground Truth: The "ground truth" here is fundamentally technical adherence to performance standards and comparison to a predicate device's established image quality using a phantom. It's not clinical diagnosis, pathology, or outcomes data. The i.b.a. Test Device DIGI-13 (a device for quality tests at CR and DR systems) served as a standard for image quality assessment.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/machine learning device. There is no mention of a "training set" in the context of diagnostic algorithms.

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

Ground Truth Establishment for Training Set: Not applicable. As there is no training set for a diagnostic algorithm, there's no ground truth established in that context.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 7, 2017

MinXray, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K171353

Trade/Device Name: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB, LLZ Dated: May 3, 2017 Received: May 9, 2017

Dear Mr. 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. 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Sincerely,

Michael D'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) K171353

Device Name

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

Indications for Use (Describe)

Intended for use by a qualified trained physician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

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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510(k) Summary: 510(k) Number K171353 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Date Prepared: May 27, 2017 Contact: Keith Kretchmer, President

1. Identification of the Device: Trade/Device Name: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
1. Equivalent legally marketed device: K141885 Trade/Device Name: CMDR-2ST & CMDR-2SLWT Digital Portable X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
1. Reference devices (We employ these cleared devices without modification):
- a) Trade/Device Name: K140551 Perkinelmer, XRpad 4336 MED Flat Panel Detector Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
- b) Trade/Device Name: K141440; Oehm Und Rehbein Gmbh, DicomPACS® DX-R with flat panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: Class II Product Code: MQB
1. Indications for Use (intended use): These digital radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

Description of the Device: This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: HF120/60H PowerPlus cleared in K040046, (and in K141885) OR HF100H+ cleared in K052721 OR HF1202 PowerPlus cleared in K153059. One of three cleared digital X-ray receptor panels: Toshiba FDX3543RP OR the Toshiba FDX3543RPW cleared in K162687 (and others) OR the PerkinElmer Solid State Imager, (K140551) PLUS: the dicomPACS® software package (K141885) (Same as our predicate). The X-ray generators are portable units which operate from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the formerly used Toshiba panels or PerkinElmer flat panel technology in a sleek and compact unit. The portable panels provide digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the

detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the digital x-ray receptor panel. .

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6) Substantial Equivalence Chart

Characteristic	Predicate:CMDR-2ST & CMDR-2SLWTDigital X-Ray SystemK141885	CMDR 2ST (Multiple Models)	CMDR 2SPE (Multiple Models)	Integris
Intended Use:	Intended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography	SAME	SAME	SAME
Configuration	Mobile System with digital x-ray panel and imageacquisition computer	SAME	SAME	SAME
Computer	Dell laptop	Dell Precision M3510 or DellLatitude 14 (ruggedized)	Dell Precision M3510 or DellLatitude 14 (ruggedized)	Beckhoff C6920/C6925
X-rayGenerator(s)(All made byMikasa X-Ray)	HF120/60H PowerPlus(K040046)	SAME ORHF100H+ (K052721)HF1202H PowerPlus (K153059)	SAME ORHF100H+ (K052721)HF1202H PowerPlus (K153059)	HF1202H PowerPlus (K153059)
BasicGeneratorCharacter-istics	120 VAC Line operatedHF120/60H PowerPlus™produces up to 120 kVP and2.4 kW peak	SAME ORHF100H+: up to 100 kVp and 2kW peakHF1202H PowerPlus: up to 120kVp up to 3.0 kW peak	SAME ORHF100H+: up to 100 kVp and 2 kWpeakHF1202H PowerPlus: up to 120 kVpup to 3.0 kW peak	HF1202H PowerPlus: up to 120kVp up to 3.0 kW peak
Collimator	Collimare LED Collimator	Collimare LED Collimator	Collimare LED Collimator	Collimare LED Collimator
Characteristic	Predicate:CMDR-2ST & CMDR-2SLWTDigital X-Ray SystemK141885	CMDR 2ST (Multiple Models)	CMDR 2SPE (Multiple Models)	Integris
GeneratorPhoto(s)	HF120/60HPPWV PowerPlusImage: HF120/60HPPWV PowerPlus generator	HF120/60HPPWV PowerPlusImage: HF120/60HPPWV PowerPlus generatorOR: HF100H+Image: HF100H+ generatorOR: HF1202H PowerPlusImage: HF1202H PowerPlus generator	CMDR 2SPE 120/60 PPImage: CMDR 2SPE 120/60 PP generatorOR: HF100H+Image: HF100H+ generatorOR: HF1202H PowerPlusImage: HF1202H PowerPlus generator	HF1202H PowerPlusImage: HF1202H PowerPlus generator
Digital X-rayPanelSupplied	Toshiba FDX3543RP	Toshiba FDX3543RPW. Note:this panel was cleared inK143257	PerkinElmer XRpad 4336 (Cleared inK140551)	PerkinElmer XRpad 4336 (Clearedin K140551)
Characteristic	Predicate:CMDR-2ST & CMDR-2SLWTDigital X-Ray SystemK141885	CMDR 2ST (Multiple Models)	CMDR 2SPE (Multiple Models)	Integris
PanelPerformance	Pixel size 143 x 143μmMatrix size 2448x2984Size 14" x 17"	Pixel Pitch 140 μ mPixel Matrix 2466 (H) x 3040 (V)Size 14" x 17"	Pixel size 100 x 100μmMatrix size 3556 × 4320Size 14" x 17" (Cleared in K140551)	Pixel size 100 x 100μmMatrix size 3556 × 4320Size 14" x 17" (Cleared inK140551)
Panel PowerSource	DC Adapter	DC Adapter or Lithium Ionrechargeable battery	DC Adapter or Lithium Ionrechargeable battery	DC Adapter or Lithium Ionrechargeable battery
PanelInterface	Ethernet	Ethernet or Wi-Fi wireless, panelcleared in	Ethernet or Wi-Fi wireless, panelcleared in K140551	Ethernet or Wi-Fi wireless, panelcleared in K140551
PerformanceStandard	21 CFR 1020.30	SAME	SAME	SAME
PACSsoftware	dicomPACS® (Cleared inK141440)	dicomPACS® (Cleared with theToshiba panels in K141440)	dicomPACS® (Cleared with thePerkinElmer panel in K141440)	dicomPACS® (Cleared with thePerkinElmer panel in K141440)
Power Source	120 V 50/60 Hz AC 20 amp	SAME	SAME	SAME
Digital PanelPower Source	120 V 50/60 Hz AC	120 V 50/60 Hz AC or LithiumIon Rechargeable Battery.	120 V 50/60 Hz AC or Lithium IonRechargeable Battery.	120 V 50/60 Hz AC or Lithium IonRechargeable Battery.
Digital Panel	Image: Digital Panel	Image: Digital Panel	Image: Digital Panel	Image: Digital Panel
Characteristic	Predicate:CMDR-2ST & CMDR-2SLWTDigital X-Ray SystemK141885	CMDR 2ST (Multiple Models)	CMDR 2SPE (Multiple Models)	Integris
Model Details	HF120/60HPPWV Generatorwith Toshiba FDX3543RP andO&R Imaging Software	CMDR 2ST 100+/ DP for DellPrecision or a /DL for DellLatitude ComputerUses HF100H+ Generator withToshiba FDX3543RP and O&RImaging SoftwareCMDR 2STW 100H+/DP for DellPrecision or a /DL for DellLatitude ComputerUses HF100H+ Generator withToshiba FDX3543RPW and O&RImaging SoftwareCMDR 2STW 1202/DP for DellPrecision or a /DL for DellLatitude ComputerUses HF1202 Generator withToshiba FDX3543RPW and O&RImaging SoftwareCMDR 2STW-MIL (Uses DellLatitude 14 with theHF120/60HPPWV Generatorwith Toshiba FDX3543RPW andO&R Imaging Software	CMDR 2SPE 120/60 PPCMDR 2SPE 100H+CMDR 2SPE 1202(The suffix is the generator modelnumber)Add a /DP for Dell PrecisionComputer or a /DL for Dell LatitudeComputerAll use the PerkinElmer XRpad 4336and O&R Imaging Software	Integris.Panel: Perkin Elmer WirelessXRpad 4336 and O&R ImagingSoftwareComputer: BeckhoffC6920/C6925Generator: HF1202H PowerPlus

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1. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.
  Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination. NO HARDWARE OR SOFTWARE MODIFICATIONS TO ALREADY CLEARED DEVICES WERE REQUIRED TO CREATE THESE NEW MODELS.
1. Summary of non-clinical testing: Prototype systems covering all generator/panel combinations were assembled and tested. First the dicomPACS® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. A Wi-Fi connection was confirmed between the PerkinElmer panel and the Dell laptop. The panel was confirmed to be charged and turned on. Then the MinXray HF portable generator was turned on. The MinXray portable X-ray generator was set to generate an exposure. The generator was aimed at the PerkinElmer panel, and a radiographic phantom was placed on the panel. Several test exposures showed that the system was operating properly. No modifications were necessary to any of the hardware or software other than changing the digital panel. The completed system complies with DHHS radiation safety standards currently in effect, and has undergone testing for compliance with UL 60601-1 (2005) (Electrical medical device safety), IEC 60601-1-2 (2007) (Electromagnetic Compatibility). Additionally, the HF1202H PowerPlus generator meets IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. The other generators were designed and cleared prior to the isuance of this standard. The software supplier Oehm Und Rehbein GmbH verified compatibility with the new PerkinElmer digital panel and supplied us with a test report. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
  We employed the i.b.a. Test Device DIGI-13, a device for quality tests at CR and DR systems (e.g. for acceptance tests according to DIN V 6868-58 and constancy tests according to DIN 6868-13) to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested. The images were evaluated and found to be of diagnostic quality.
1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of MinXray Inc. that the modified Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it 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.