Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as preoperative software for simulating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Device Description

The True 3D Viewer system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.

AI/ML Overview

The provided text is a 510(k) Summary for the EchoPixel True 3D Viewer device. It outlines the device's description, intended use, and the basis for its substantial equivalence to predicate devices. However, the document does not contain the detailed information required to describe acceptance criteria and the specifics of a study proving the device meets those criteria, especially regarding clinical performance with quantitative metrics like sensitivity, specificity, or reader performance improvement with AI assistance.

The document primarily focuses on:

Regulatory Classification: Identifying the device as Class II, product code LLZ (Picture archiving and communications system, 21 CFR 892.2050).
Substantial Equivalence: Comparing the EchoPixel True 3D Viewer to existing predicate devices (Surgical Theater Surgery Rehearsal Platform and Vital Images Vitrea 2) based on intended use and technological characteristics.
Performance Data: This section broadly states that the device was validated according to the company's documented development and test procedures, including testing against applicable standards (IEC EN, ANSI 60601-1, IEC60601-1-2, NEMA PS 3.1 3.18 (DICOM), ISO 14971, and FDA Guidance on Software Contained in Medical Devices). It mentions "testing that fulfills the requirements" and "verification and validation was performed on qualified phantoms as well as in simulated use conditions."

Crucially, the document does not provide:

A table of specific acceptance criteria (e.g., minimum sensitivity, specificity, or performance metrics).
Reported device performance data against those criteria.
Details about a clinical study involving human readers or a standalone AI performance evaluation.
Information on sample size for test or training sets, data provenance, number/qualifications of experts, or ground truth establishment methods for clinical performance.
Any mention of MRMC studies or an effect size for human reader improvement.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text, as the necessary details are not present.

What can be inferred from the document regarding "performance data," though it doesn't meet the detailed request:

The "Performance Data" section indicates that the validation was focused on technical and regulatory compliance standards rather than a clinical performance study with human readers or AI metrics. The "acceptance criteria" referred to here are likely related to:

Safety and Essential Performance: Meeting standards like IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).
Risk Management: Compliance with ISO 14971.
DICOM Conformance: Adherence to NEMA PS 3.1 3.18 (DICOM).
Software Design Control: Meeting 21 CFR Part 820.30 requirements and FDA Guidance on Software.
Rendering and Interaction Fidelity: The statement "verification and validation was performed on qualified phantoms as well as in simulated use conditions" suggests testing of the 3D rendering accuracy, interactive manipulation, and display of image data.

In summary, based on the provided text, the device's "performance" was evaluated for substantial equivalence through:

Compliance with general medical device safety and quality system standards.
Demonstration of its ability to process, review, and display multi-dimensional digital images, as stated in its intended use, likely via phantom studies and simulated use cases to confirm functionality and accuracy of rendering/interaction features.

The document does NOT describe:

A table of acceptance criteria and reported device performance related to diagnostic accuracy, reader improvement, or AI standalone performance.
Sample size for test set or data provenance for a clinical performance study.
Number or qualifications of experts for ground truth establishment.
Adjudication method for a test set.
MRMC comparative effectiveness study or effect size.
Standalone algorithm performance.
Type of ground truth used for a clinical performance study.
Sample size for a training set.
How ground truth for training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

January 21, 2015

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

Re: K142107

Trade/Device Name: EchoPixel True 3D Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 30, 2014 Received: January 2, 2015

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. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below. 510(k) Number (if known) K142107 N/A Device Name EchoPixel True 3D Viewer Indications for Use (Describe) Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as preoperative software for simulating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. 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) This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services

Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Attachment 1

510(k) Summary December 15, 2014

Sponsor:	EchoPixel Inc.2490 Hospital Dr.Suite 310Mountain View CA 94040
Contact Person:	Sergio Aguirre
Telephone:	(650) 404 7097
Fax:	(650) 941 5795
Submission Date:	June 3, 2014
Device Name:	EchoPixel True 3D Viewer (t3 Viewer)
Common Name:	Imaging Software System
Classification:
Regulatory Class:	II
Review Category:	System, image processing, radiological21CFR892.2050 (LLZ)
Classification Panel:	Radiology

A. Legally Marketed Predicate Devices

The t3D Viewer is substantially equivalent to the "Primary" predicate, the Surgical Theater Surgery Rehearsal Platform (K123023) with regard to both its intended use and its core technological characteristics. The Vitrea 2 v3.8 manufactured by Vital Images (K052632) is a "reference" predicate and has an intended use and core technology that is also substantially equivalent to the t3D Viewer.

B. Device Description:

The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to

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visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.

C. Intended Use

Primary Predicate	Reference Predicate	Subject Device
Surgical TheaterSurgery Rehearsal Platform	Vital ImagesVitrea 2	True 3D ViewerEcho Pixel
K123023	K052632
intended for use as asoftware inter-face andimage segmentation systemfor the transfer of imaginginformation from CT orMR medical scanner to anoutput file. It is alsointended as pre-operativesoftware forsimulating/evaluatingsurgical treatment options.	Vitrea 2 is a medicaldiagnostic system thatallows the processing,review, analysis,communication and mediainterchangeof multi-dimensional digitalimages acquired from avariety of imaging devices.	Intended as a medical diagnosticimaging system that allows theprocessing, review, analysis,communication and mediainterchange of multi-dimensionaldigital images acquired from CT orMR imaging devices. It is alsointended as pre-operative softwarefor simulating / evaluating surgicaltreatment options. The True 3DViewer is designed for use byhealth care professionals and isintended to assist the clinician whois responsible for making all finalpatient management decisions.
Intended Users	Intended Users	Intended Users
Health Care Professionals	Health Care Professionals	Health CareProfessionals
Intended Environment forUse	Healthcare facilities such ashospitals and clinics	Healthcare facilities such ashospitals and clinics
Class II	Class II	Class II
21CFR 892.2050;LLZ	21CFR 892.2050; LLZ	21CFR 892.2050;LLZ
Image analysis features:interactive manipulation,tag, annotate, measure,segment	Image analysis features:interactive manipulation,tag, annotate, measure,segment	Image analysis features: interactivemanipulation, tag, annotate,measure, segment

D. Substantial Equivalence

E. Performance Data

Every specification of the True 3D Viewer device has been validated according to the 8 company's documented development and test procedures. The verification and validation testing conducted by a certified test laboratory included testing to the following

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applicable standards: IEC EN, ANSI 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (3rd Edition),

IEC60601-1-2 Medical Electrical Equipment --- Part 1-2: General Requirements for Basic @ Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests:2007-03,
g Risk Management, in accordance with IEC 60601-1 3rd Ed. and ISO 14971 and IEC 60601-1-4 or Clause 14.
NEMA PS 3.1 3.18 (2008), Digital Imaging and Communications in Medicine g (DICOM) Set PS 3.1

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 that fulfillsthe requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design. Verification and validation was performed on qualified phantoms as well as in simulated use conditions.

F. Conclusion

The True 3D Viewer is substantially equivalent to the Primary predicate device with regards to intended use and technological characteristics. It is also substantially equivalent to the reference predicate. 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).