The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.

Device Description

The True 3D Viewer Software is a software application that enables a Health Care Professional (HCP) to visualize and interact with DICOM image data, from CT, MRI and Ultrasound imaging modalities, to assist in clinical decision making.

The application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The True 3D Viewer Software application enables HCPs to visualize and interact with image data and depictions of tissue and organs in an open 3D space as if they were real physical objects. The objects that the software will display are 2D MPR images, 3D volumes, 3D surfaces, labels, and measurements. The system is intended for use in the clinic or hospital settings. Information on performance tested hardware that is provided by the user is described in product labeling.

AI/ML Overview

The provided text is a 510(k) summary for the EchoPixel True 3D Viewer Software and does not contain detailed information about specific acceptance criteria, device performance metrics, or the study methodologies typically found in the clinical study report itself. The document primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not explicitly available in this document.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise quantitative acceptance criteria or reported device performance metrics in terms of clinical accuracy or statistical targets. Instead, it makes a general statement about meeting design requirements and user needs.

Acceptance Criterion	Reported Device Performance
Functional & Performance Specifications (Implicit – all design requirements and user needs met)	"Every specification of the True 3D Viewer Software device has been validated according to the company's documented development and test procedures." "Results of performance testing demonstrated that the device met the design requirements and as well as the user needs."
Compliance with Standards	Complies with: - PS 3.1 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set PS 3.1 - ISO 14971 - Standard for the Application of Risk Management to Medical Devices - IEC/TR 80002-1:2009 - Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software - IEC 62304- Medical Device Software-Software Lifecycle Processes - 21 CFR Part 820.30 (Design Control process) - FDA "Guidance on Software Contained in Medical Devices"
Safety and Efficacy (Indirect)	"Based on the performance data provided in the submission these differences [from predicate] do not introduce new issues related to safety and efficacy."

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

Not explicitly stated in the document. The document mentions "performance data provided in the submission" and "performance testing" but does not specify the sample size of cases, images, or subjects used for testing, nor their provenance (e.g., country of origin, retrospective/prospective nature).

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

Not explicitly stated in the document. The document mentions the device is intended for use by "health care professionals" who make "final patient management decisions" and that human intervention is involved in image interpretation. However, it does not specify if experts were used to establish ground truth for a test set, their number, or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not explicitly stated in the document. Without information on how ground truth was established, the adjudication method cannot be determined.

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

No indication of an MRMC study related to AI assistance. The device is described as "imaging software" for visualization and interaction with DICOM data, not as an AI-assisted diagnostic tool. The document focuses on its functionality as a viewer and processing tool, and its substantial equivalence to a predicate viewer. Therefore, an MRMC comparative effectiveness study for AI assistance would not be applicable in this context, and no effect size is mentioned.

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

No indication of a standalone algorithm performance study. The device is "intended to be used by health care professionals, who are responsible for making all final patient management decisions." This implies human-in-the-loop use. The 510(k) summary does not present performance data for a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated in the document. Given the device's function as a 3D viewer and processing software for existing DICOM images, the "ground truth" for its performance testing would likely refer to the accuracy of its rendering, measurements, and manipulation features compared to expected outputs or calculations from the original DICOM data. It's not a diagnostic device that would typically establish ground truth against pathology or outcomes data in the traditional sense, but rather a tool to accurately display and interact with existing diagnostic information.

8. The sample size for the training set

Not applicable/Not stated. This device is described as imaging software for visualization and interaction, not a machine learning or AI algorithm that typically requires a "training set" in the context of diagnostic interpretation. Therefore, a sample size for a training set is not provided.

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

Not applicable/Not stated. As the device does not appear to be an AI/ML diagnostic algorithm requiring a training set, the establishment of ground truth for such a set is not discussed.

Summary

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

March 3, 2017

EchoPixel Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K170167

Trade/Device Name: True 3D Viewer Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 22, 2017 Received: February 23, 2017

Dear Mr. Job:

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.

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) K170167

Device Name

True 3D Viewer Software

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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510(k) Summary

Prepared March 1, 2017

Sponsor:	EchoPixel Inc.2490 Hospital Dr.Suite 310Mountain View CA 94040
Contact Person:	Sergio Aguirre
Telephone:	(650) 404 7097
Fax:	(844) 273 7766
Submission Date:	December 20, 2016
Device Name:	True 3D Viewer Software
Common Name:	Imaging Software
Classification:Regulatory Class:	II
Review Category:	System, image processing, radiological21CFR892.2050 (LLZ)
Classification Panel:	Radiology

A. Legally Marketed Predicate Devices

The modified True 3D Viewer Software is substantially equivalent to the True 3D Viewer cleared pursuant to K142107.

B. Device Description:

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C. Intended Use

	Predicate DeviceEchoPixel True 3D ViewerK142107	Subject DeviceEchoPixel True 3D Viewer SoftwareModification
Indicationsfor Use	Intended as a medical diagnosticimaging system that allows theprocessing, review, analysis,communication and media interchangeof multi-dimensional digital imagesacquired from CT or MR imagingdevices. It is also intended as pre-operative software for simulating /evaluating surgical treatment options.The True 3D Viewer is designed foruse by health care professionals and isintended to assist the clinician who isresponsible for making all final patientmanagement decisions	The True 3D Viewer Software isintended for processing, review,analysis, communication and mediainterchange of digital images acquiredfrom CT, MRI and Ultrasound sources.It is also intended as software for pre-operative analysis of surgical options.The True 3D Viewer Software isdesigned for use only with performancetested hardware specified in the userdocumentation. The device is intended tobe used by health care professionals,who are responsible for making all finalpatient management decisions.
IntendedUsers	Intended UsersHealth Care Professionals	Intended UsersHealth Care Professionals
Class II	Class II	Class II
Regulation /Code	21CFR 892.2050;LLZ	21CFR 892.2050;LLZ
Imageanalysisfeatures:	Image analysis features: interactivemanipulation, tag, annotate,measure, segment	Image analysis features: interactivemanipulation, tag, annotate, measure,segment
Components	Hardware and software	Software only
Hardware	Included in system	Provided by user
Display	Stereoscopic display part ofsystem;23.6 inch (Diagonal);Resolution - 1980x1080 full HDAspect Ratio - 16:9; Contrast Ratio -50:1 for 2D and 3D; Color - 16.7million; Frame Rate - 120 Hz	Stereoscopic display;Performance tested hardware is providedby user
Stylus	Stylus part of system; Buttons - Three programmable buttons; Tracking: 6 degrees of freedom (DOF) sensor; Vibrate Function – Small DC vibrating motor:Infrared LED – 2 IR LED's, one at each edge	Stylus; Performance tested hardware is provided by user
3D Glasses	3D glasses are part of system; Circular Polarized passive eyewear with trackable markers	3D glasses; Performance tested hardware is provided by user
Personal computer (PC)	PC part of system; Windows 7 or 10 (64bit) ; Four core 2.5 GHz or equivalent Zeon processor ; 8 GB of system memory (RAM); NVidia Quadro Graphics Processing Unit (GPU) with 4GB of video memory; Open-GL 1.4 support (or later) stereo compatible graphics with DVI-d and/or Display Port 500GB drive	PC Performance tested hardware is provided by user

D. Substantial Equivalence

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Based on the above comparison there is both reduced capability stated in the indications for use as well as some additional capability and software enhancements. Based on the performance data provided in the submission these differences do not introduce new issues related to safety and efficacy.

Comparison Table 2 – Technological Characteristics

Feature	Predicate DeviceEchoPixel True 3D ViewerK142107	Subject DeviceEcho Pixel Modified True3D Viewer Software
Data Source	CT and MR DICOM Images	CT, MR and UltrasoundDICOM Images
DICOM compliant	Yes	Yes
Display Images	Yes	Yes
3D display mode	Yes	Yes
Select Images for closerexamination	Yes	Yes
Original 2D imageremains on the displayscreen during other views	Yes	Yes
Human intervention forinterpretation of images	Yes	Yes
Multi-dimensionalvisualization	Yes	Yes

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Interactively manipulateimages in real time tovisualize anatomy	Yes	Yes
Visual Tracking	Yes	Yes
Provides the viewer theability to view spatiallyregistered 2D MPR	Yes	Yes
Interact with mages usingstylus control	Yes	Yes

In summary based on the comparison of technology technological characteristics of the subject device compare to the predicate are substantially equivalent. Based on the performance data provided in the submission these differences do not introduce new issues related to safety and efficacy.

E. Performance Data

Every specification of the True 3D Viewer Software device has been validated according to the company's documented development and test procedures. The verification and validation testing included testing to the following applicable standard:

· PS 3.1 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set PS 3.1
· ISO 14971 -Standard for the Application of Risk Management to Medical Devices
· IEC/TR 80002-1:2009 -Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
· IEC 62304- Medical Device Software-Software Lifecycle Processes

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing fulfilling the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design.

F. Conclusion

The True 3D Viewer Software is substantially equivalent to the predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.

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).