This digital radiographic system is 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.

Device Description

This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates 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 Toshiba flat panel technology in a sleek and compact unit. The portable panel provides 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 supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.

AI/ML Overview

The provided document is a 510(k) premarket notification for a digital portable X-ray system. The aim of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance criteria through a study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert qualifications, and ground truth establishment, which are typical for studies validating the performance of a new diagnostic algorithm or device feature, are not applicable here. This document focuses on demonstrating that a modified device (changing the digital panel supplier) performs equivalently to an already cleared device.

Here's an attempt to extract relevant information given the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: While specific numerical acceptance criteria for image quality aren't explicitly stated in a table format, the underlying criterion is that the diagnostic image quality of the new device (with the Toshiba panel) must be comparable to that of the predicate device (with the Varian panel).
Reported Device Performance: "The images were evaluated by a board certified radiologist and found to be of comparable diagnostic quality."

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Diagnostic Image Quality	Comparable to predicate device	Images found to be of comparable diagnostic quality
Safety and Effectiveness	As safe and effective as predicate device	Results of bench testing indicates new device is as safe and effective
Proper System Operation	Fully verified upon installation	Verified to work properly and produce diagnostic quality images as good as predicate
Compliance with Radiation Safety Standards	DHHS radiation safety standards (21 CFR 1020.30 & 1020.31)	Complies with DHHS radiation safety standards
Electrical Medical Device Safety	UL 60601-1	Undergone testing for compliance with UL 60601-1
Electromagnetic Compatibility	IEC 60601-1-2	Undergone testing for compliance with IEC 60601-1-2
Software Compliance	NEMA PS 3.1-3.20 (DICOM)	Software tested to and complies with DICOM standard

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

Sample Size for Test Set: "Several test exposures" were performed using "Supertech" lung/chest phantom and other phantoms. A precise number is not given.
Data Provenance: Not applicable as phantom images were used, not patient data with specific country of origin. This was a prospective test in the sense that the new system was assembled and then tested with phantoms.

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

Number of Experts: One
Qualifications of Experts: "A board certified radiologist." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: "None" for comparison, as only one radiologist evaluated the images. The radiologist made a direct comparison to images from the predicate device.

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 study was NOT done. This device is an X-ray system, not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable in the context of an X-ray imaging device. The device's "performance" is its ability to produce diagnostic images. The evaluation described involves a human (radiologist) interpreting these images.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" for the comparison was the diagnostic quality of images produced by the predicate device (MinXray CMDR-2S with Varian 4336R panel). This is a comparison of diagnostic image quality as assessed by an expert, rather than reference to pathology, outcomes data, or a different "ground truth" standard. The phantoms represent known anatomical structures.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a 510(k) submission for a medical device (X-ray system), not an AI/machine learning algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable, as this is not an AI/machine learning algorithm with a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

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

September 18, 2014

MinXray, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: 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 Code: IZL, MQB, LLZ Dated: August 15, 2014 Received: August 19, 2014

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 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.

{1}------------------------------------------------

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/Resourcesfor You/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 yours.

Sm. 77)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141885

Device Name CMDR-2ST & CMDR-2SLWT

Indications for Use (Describe)

This digital radiographic system is intended for use by a qualified/trained physician or both adult and pediatric subjects for taking diagnostic x-rays. (Not for mammographic use).

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

510(k) Summary: 510(k) Number K141885 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Tel. 1-847-564-0323 Fax 1-847-564-9040 Date Prepared: August 15, 2014 Keith Kretchmer, President Contact:

Identification of the Device: 1. Proprietary-Trade Name: CMDR-2ST & CMDR-2SLWT Digital Portable X-ray System
1. Classification Name: Mobile x-ray system, Product Code 90 IZL and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Picture Archiving and Communications System 90 LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System Regulation Number: 21 CFR 892.1720
1. Equivalent legally marketed device: MinXray CMDR-2S, K100449
1. Indications for Use (intended use): This digital radiographic system is 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.
1. Description of the Device: This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates 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 Toshiba flat panel technology in a sleek and compact unit. The portable panel provides 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 supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.
1. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is 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.

Characteristic	MinXray CMDR-2S Digital Diagnostic X-RaySystem K100449	CMDR-2ST & CMDR-2SLWT
Intended Use:	Intended for use by a qualified/trainedphysician or technician on both adult andpediatric subjects for takingdiagnostic x-rays. Not for mammography	SAME
Configuration	Mobile System	SAME
Computer	Dell laptop	SAME

7. Substantial Equivalence Chart

{4}------------------------------------------------

Characteristic	MinXray CMDR-2S Digital Diagnostic X-RaySystem K100449	CMDR-2ST & CMDR-2SLWT
Generator	High Frequency HF120/60H PowerPlus™	SAME
Digital X-ray Panel Supplier	Varian 4336R	Toshiba FDX3543RP
Panel Performance	Pixel size 139 x 139 μmMatrix size 2,560 x 3,072Size 14" x 17"	Pixel size 143 x 143μmMatrix size 2448×2984Size 14" x 17"
Panel Interface	Ethernet	SAME
Performance Standard	21 CFR 1020.30	SAME
Generator	Uses high frequency generator made byMikasa X-Ray in Japan. 80 khz.	SAME generator
PACS software	dicomPACS®	dicomPACS®
Power Source	120 V 50/60 Hz AC 20 amp	SAME
Digital Panel	Image: Digital Panel	Image: Digital Panel

1. Summary of non-clinical testing: A prototype system was assembled and tested. First the dicomPAC® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. Next, the synchronization circuit was connected between the Mikasa HF portable generator and the Toshiba panel. The Ethernet cable was then connected between the Toshiba panel and the Dell laptop. The panel was connected to the AC power source and turned on. Then the Mikasa HF portable generator was turned on. The Mikasa generator was set to generate an exposure. The generator was aimed at the Toshiba 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 complies with DHHS radiation safety standards currently in effect, i.e. 21 CFR 1020.30 and 21 CFR 1020.31 and has undergone testing for compliance with UL 60601-1 (Electrical medical device safety), IEC 60601-1-2 (Electromagnetic Compatibility). The software was tested to and complies with the NEMA PS 3.1-3.20(DICOM) standard. The Toshiba detector has been previously cleared under K131211.
1. Summary of clinical testing: Because this same Toshiba panel/software combination has been cleared by FDA before, a full clinical trial per the FDA guidance document on solid state imaging devices was deemed to be unnecessary, per the FDA "Least Burdensome" guidance. Instead we employed "Supertech" lung/chest phantom and other phantoms to obtain images from both the predicate and the new digital panel. The images were evaluated by a board certified radiologist and found to be of comparable diagnostic quality.
1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of MinXray Inc. that the CMDR-2ST & CMDR-2SLWT Digital Diagnostic X-Ray System is 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.