The Viewing Client Mobile is a software application that is intended to be used by qualified medical professionals for the review of medical images derived from multiple modalities. Clinical reports can also be viewed using this device.

The Viewing Client Mobile application can be used to perform image manipulation (for example, window width and level, zoom, pan, rotation) and measurement. It can display both lossless and lossy compressed images. For lossy images, the user must determine if the level of loss is acceptable for their purposes.

The Viewing Client Mobile application provides wireless and portable access to medical images from only the following modalities: MRI, CT, X-ray and Ultrasound. It is not intended to replace a full workstation and should be used only when there is no access to one.

The Viewing Client Mobile application must not be used for the primary interpretation of mammographic images.

Device Description

AXON Medical Technology Corp.'s Viewing Client Mobile is a viewer that facilitates the secure viewing of 2D, DICOM 3.0-compliant soft-copy imaging studies both within and without the Enterprise context. The product operates through an API.

Viewing Client Mobile is used under mobile viewing conditions within the device's intended use. Viewing Client Mobile app runs on iOS platforms.

Core measurement and image manipulation tools provided by the Viewing Client Mobile include zoom, pan, invert, W/L, Pixel Value/ Line/ Angle, ROI and CINE. The Viewing Client Mobile also supports multiseries and study display.

The Viewing Client Mobile app operates on the iPad, a portable, "off-the-sheh" hardware device, used to wirelessly access medical images under mobile conditions, and is therefore more sensitive to factors not typical for reading room workstations (e.g. display condition, variable lighting, viewing angle, etc.). The user is therefore instructed to properly follow the operating instructions provided with the hardware device, utilize the Viewing Client Mobile's risk mitigation features and heed precautions related to safe device use.

AI/ML Overview

The provided text describes the AXON Medical Technologies Corp.'s "Viewing Client Mobile" device and its performance testing.

Here's an analysis of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table with quantitative acceptance criteria for diagnostice performance and measured values against those criteria. Instead, it states that "in each case acceptance criteria was met" for bench testing and that clinical testing resulted in positive qualitative feedback.

Bench Testing:

Acceptance Criteria Category	Reported Device Performance
Optimal Viewing Conditions (for diagnostic reads under prescribed illuminance ranges)	"All supported off-the-shelf mobile platforms... can be calibrated to provide optimal viewing conditions."
Software Performance Requirements and Specifications	"In all cases, the software passed its performance requirements and met specifications."

Clinical Testing:

Acceptance Criteria Category	Reported Device Performance
Image Quality (overall, sharpness, contrast)	"All radiologists indicated that the image quality of Viewing Client Mobile was acceptable in terms of overall quality, sharpness and contrast and that it would enable diagnostic reads to be made confidently."
Absence of Image Artifacts	"No image artifacts were noted by the reviewers."
Diagnostic Image Viewing Capability	"Results of the clinical testing affirm the diagnostic image viewing capability of Viewing Client Mobile when used as indicated."

2. Sample Size and Data Provenance

Bench Testing: The sample size for bench testing is not explicitly stated as a number of devices or platforms, but it was performed "on all supported off-the-shelf mobile platforms." The data provenance is internal to AXON Medical Technologies Corp.
Clinical Testing: The document does not specify the exact sample size (number of patient cases or images) used for the clinical image quality demonstration study. The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

Bench Testing: A single expert "in luminance and illuminance testing" validated the test plan. Their specific qualifications (e.g., years of experience, certifications) are not detailed beyond being an "expert."
Clinical Testing: The ground truth was established by "certified Radiologists." The number of radiologists is referred to as "All radiologists," implying at least more than one, but a specific count is not provided. Their qualifications are stated as "certified Radiologists," but no further details (e.g., years of experience, subspecialty) are given.

4. Adjudication Method

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for either the bench testing or the clinical testing. For clinical testing, it states "All radiologists indicated" a consensus, but the process to reach that consensus (e.g., independent review followed by discussion, or a single collective assessment) is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not explicitly described. The clinical study was an "Image Quality Demonstration study" where radiologists performed a "side-by-side comparison of the predicate and Viewing Client Mobile to evaluate and compare the overall image quality." This appears to be a qualitative comparison rather than a formal MRMC study to quantify performance improvement with/without AI assistance.

6. Standalone Performance

Yes, a standalone performance assessment was conducted. The "Viewing Client Mobile" is the device being assessed in isolation (i.e., its performance in displaying images), with radiologists acting as the "human-in-the-loop" for qualitative assessment. The study was focused on the device's ability to display images acceptably for diagnostic reads by human radiologists, not on an algorithm's diagnostic output without human review.

7. Type of Ground Truth Used for Test Set

Bench Testing: The ground truth was established by conformance to "test guidelines provided in AAPM Assessment of Display Performance for Medical Imaging Devices (2005)" and internal specifications validated by an expert.
Clinical Testing: The ground truth for the clinical study was expert consensus based on the qualitative assessment of image quality by "certified Radiologists" compared to a predicate device. It was not pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not mention a training set. This device is a medical image viewer and processing software, not an AI/CAD algorithm that typically requires a large training dataset for model development.

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

Not applicable, as no training set is mentioned for an AI/CAD algorithm. The device is a viewer; its functionality is based on display and manipulation of existing DICOM data, not on learning from a dataset to make diagnostic predictions.

Summary

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

March 6, 2015

AXON Medical Technologies Corp. % Mr. Chas Yu Quality Assurance Manager 18 Tanager Avenue, Suite 303 Toronto, Ontario M4G 3R1 CANADA

Re: K141536

Trade/Device Name: Viewing Client Mobile Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2015 Received: March 2, 2015

Dear Mr. Yu:

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.

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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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K141536

Device Name Viewing Client Mobile

Indications for Use (Describe)

The Viewing Client Mobile application can be used to perform image manipulation (for example, window width and level, zoom, pan, rotation) and measurement. It can display both lossless and lossy compressed images, the user must determine if the level of loss is acceptable for their purposes.

The Viewing Client Mobile application must not be used for mammography.

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

2 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)

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Image /page/3/Picture/0 description: The image shows the logo for Axon Medical Technologies Corp. The logo consists of a blue abstract symbol on the left, followed by the word "axon" in black. Below the word "axon" is the text "Medical Technologies Corp." also in black. The abstract symbol is made up of four blue circles connected to a central white circle.

5 510(k) Summary [21 CFR 807.92(c)]

General Information 5.1

5.1.1 Manufacturer Information

AXON Medical Technologies Corp. 18 Tanager Avenue Suite 303 Toronto, Ontario Canada M4G 3R1 Email: peter.bak@axonmed.com Tel: (416) 421-2588 Fax: (416) 421-5603

5.1.2 FDA Registration No.

Pending Approval of first 510(k) submission.

5.1.3 Submitter Information

Chas Yu Manager, Quality Assurance Tel: (604) 679-0976 Email: chas.yu@axonmed.com

Date Summary Prepared: March 31st, 2014

5.1.4 Device Information

Trade Name: Viewing Client Mobile Common Name: Medical Image Processing Software Classification Name: Picture Archiving and Communication System (PACS), (21 CFR Part 892.2050, Product Code LLZ)

5.1.5 Predicate Devices

K112930 MobileMIM MIM Software Inc. (formerly MIMvista Corp.)

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Image /page/4/Picture/0 description: The image shows the logo for Axon Medical Technologies Corp. The logo consists of a blue abstract symbol resembling interconnected circles, followed by the word "axon" in a dark gray, sans-serif font. Below the word "axon" is the text "Medical Technologies Corp." in a smaller, lighter gray font.

5.2 Device Description

Viewing Client Mobile is used under mobile viewing conditions within the device's intended use. Viewing Client Mobile app runs on iOS platforms.

5.3 Intended Use/ Indications for Use

The Viewing Client Mobile application must not be used for the primary interpretation of mammographic images.

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Image /page/5/Picture/0 description: The image shows the logo for Axon Medical Technologies Corp. The logo consists of a blue abstract symbol on the left, followed by the word "axon" in black, and the words "Medical Technologies Corp." in a smaller font size below the word "axon". The abstract symbol appears to be four blue circles arranged in a square pattern.

Point of Comparison	Viewing Client Mobile	Mobile MIM
510(k) Number		K112930
Intended Use /Indications for Use	The Viewing Client Mobile is asoftware application that is intendedto be used by qualified medicalprofessionals for the review ofmedical images derived frommultiple modalities. Clinical reportscan also be viewed using this device.The Viewing Client Mobileapplication can be used to performimage manipulation (for example,window width and level, zoom, pan,rotation) and measurement. It candisplay both lossless and lossycompressed images. For lossyimages, the user must determine ifthe level of loss is acceptable fortheir purposes.The Viewing Client Mobileapplication provides wireless andportable access to medical imagesfrom only the following modalities:MRI, CT, X-ray and Ultrasound. It isnot intended to replace a fullworkstation and should be used onlywhen there is no access to one.The Viewing Client Mobileapplication must not be used for theprimary interpretation ofmammographic images.	The Mobile MIM software programis used for the registration, fusion,and/or display for diagnosis ofmedical images from only thefollowing modalities: SPECT, PET,CT, MRI, X-Ray and Ultrasound.Mobile MIM can be used to reviewimages, contours, DVH, andisodose curves from radiationtreatment plans. Mobile MIM canbe used to approve these plans.Mobile MIM provides wireless andportable access to medical images.This device is not intended toreplace full workstations andshould be used only when there isno access to a workstation.This device is not to be used formammography.
Receive, Store, Display,and Process DigitalMedical Images	Yes	Yes
Display of ClinicalPatient Data when noaccess to a workstation	Yes	Yes
Image Fusion	No	Yes
Multiplanarreconstruction (MPR)	No	Yes
Maximum IntensityProjection (MIP)	No	Yes
Standardized UptakeValue (SUV)	No	Yes
Distant Measurements	Yes	Yes
Window/ Level	Yes	Yes
Zoom/ Pan	Yes	Yes
User Authentication	Yes	Yes
Modalities	MRI, CT, X-Ray and Ultrasound	SPECT, PET, CT, MRI, X-Ray,Ultrasound
Remote HandheldViewing Device	Yes	Yes
Operating Platform	Apple iOS	Apple iOS
HardwareRequirements	iPad 3 and 4 (Apple iOS handhelddevices)	Apple iOS Handheld Devices
InstallationRequirements	Downloadable as app	Downloadable as app
Logging of Audit Trails	Yes	No
Ambient Light Display	Yes	Yes

Technological Characteristics Comparison Table 5.4

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Image /page/6/Picture/0 description: The image shows the logo for Axon Medical Technologies Corp. The logo consists of a blue abstract symbol on the left, followed by the word "axon" in black, and the words "Medical Technologies Corp." in a smaller font below the word "axon". The abstract symbol is made up of four blue shapes arranged in a circular pattern.

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Image /page/7/Picture/0 description: The image shows the logo for Axon Medical Technologies Corp. The logo consists of a blue abstract symbol on the left, followed by the word "axon" in black, and the words "Medical Technologies Corp." in a smaller font size below the word "axon". The abstract symbol appears to be a stylized representation of a neuron or a network, which is relevant to the company's focus on medical technologies.

Verification Tool
Support for radiation treatment plans	No	Yes

Performance Testing 5.5

Bench Testing was performed on all supported off-the-shelf mobile platforms to confirm the Viewing Client Mobile can be calibrated to provide optimal viewing conditions for performing diagnostic reads under prescribed illuminance ranges.

The tests were performed in accordance with the test guidelines provided in AAPM Assessment of Display Performance for Medical Imaging Devices (2005). The Test plan was validated by an expert in luminance and illuminance testing and executed internally. Test equipment calibration is certified traceable to NIST. A total of seven tests were performed. In each case acceptance criteria was met.

Furthermore, AXON Medical Technologies has conducted verification, and functional testing on Viewing Client Mobile software. In all cases, the software passed its performance requirements and met specifications.

5.6 Clinical Testing

An Image Quality Demonstration study was performed by certified Radiologists using a variety of modalities, specifically MRI, CT, X-ray and Ultrasound, under different environmental conditions. The radiologists conducted a side-by-side comparison of the predicate and Viewing Client Mobile to evaluate and compare the overall image quality of a series of representative patient images form the range of modalities supported by the device. All radiologists indicated that the image quality of Viewing Client Mobile was acceptable in terms of overall quality, sharpness and contrast and that it would enable diagnostic reads to be made confidently. No image artifacts were noted by the reviewers. Results of the clinical testing affirm the diagnostic image viewing capability of Viewing Client Mobile when used as indicated.

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Image /page/8/Picture/0 description: The image shows the logo for Axon Medical Technologies Corp. The logo consists of a blue abstract symbol on the left, followed by the word "axon" in black, and the words "Medical Technologies Corp." in a smaller font below the word "axon". The abstract symbol is made up of four blue circles arranged in a square pattern.

Substantial Equivalence 5.7

The predicate comparison chart in tandem with the above consideration provides evidence in support of the determination that Viewing Client Mobile is substantially equivalent to K112930 MobileMIM Software Applications.

Viewing Client Mobile provides a portable diagnostic viewer of medical images substantially equivalent to K112930 MobileMIM. AXON is of the opinion that the Viewing Client Mobile does not introduce new safety or performance risks and is safe for commercial release.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).