EXA™ is a software device that receives digital images and data from various sources (i.e. CT scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, nurses, and technicians.

Device Description

EXA™ is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities, and offer an interface that users find to be quite intuitive after some initial learning. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ RAD suite.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Picture Archiving and Communications System (PACS) named EXA™. This document focuses on demonstrating substantial equivalence to a predicate device (Viztek OPAL-RAD™) through software validation and a comparison of characteristics rather than a clinical study with specific acceptance criteria related to diagnostic performance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or clinical effectiveness studies (MRMC or standalone AI) are not explicitly present or applicable in the context of this 510(k) submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the conventional sense of diagnostic performance metrics (e.g., sensitivity, specificity). The acceptance criteria were based on software verification and validation, ensuring the device meets its predetermined software requirements specifications and performs equivalently to the predicate device in terms of functionality and image handling.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Software meets predetermined requirements	Software Verification and Validation performed; device meets predetermined Software Requirements Specifications.
Equivalent functionality to predicate device	Comparison to predicate device indicates similar functionality, with described improvements.
Safe and effective as predicate device	Concluded to be as safe and effective as predicate device based on software validation and comparison.
Image quality equal to or better than predicate	Clinical images collected (likely for comparison purposes) demonstrate equal or better image quality compared to the predicate.

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

Test Set Sample Size: Not explicitly stated. The testing involved "Software Verification and Validation" and "Clinical images collected." It's likely these were internal tests rather than a formal clinical study with a defined patient cohort.
Data Provenance: Not specified. "Clinical images collected" suggests real-world data, but details about country of origin or whether it was retrospective/prospective are not provided. Given the nature of a PACS, the images themselves would originate from various imaging modalities.

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

Not applicable. The submission focuses on software functionality and image handling, not on diagnostic accuracy requiring expert ground truth in a clinical trial. The "clinical images collected" were likely used to verify image quality and system functionality, not for diagnostic performance evaluation against an expert-established ground truth.

4. Adjudication method for the test set

Not applicable. No formal adjudication method is mentioned as there's no clinical diagnostic performance study described.

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 MRMC comparative effectiveness study was done. This device is a PACS, which is infrastructure for displaying and managing medical images, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm with standalone performance. It is a PACS system.

7. The type of ground truth used

Not applicable. For a PACS, the "ground truth" would relate to the accurate storage, retrieval, processing, and display of image data conforming to DICOM standards and system specifications, rather than a clinical diagnosis.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set in the machine learning sense. The "training" for such a system refers to software development and testing based on predetermined requirements.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the (implied) acceptance criteria is described as Software Verification and Validation and Risk Analysis.

Methodology: The submission states, "The results of software validation and comparison to our predicate device indicates that the new device is as safe and effective as our predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate." It further clarifies, "The testing showed that the device meets its predetermined Software Requirements Specifications."
Conclusion: Based on the software validation and risk analysis, Viztek Inc. concluded that EXA™ 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."

Essentially, the "study" was a comprehensive software testing and comparison effort, confirming that the new PACS system performed its intended functions in a manner comparable to or better than a previously cleared PACS, and that all software requirements were met. It did not involve a clinical utility study to evaluate diagnostic accuracy or improvements for human readers.

Summary

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

December 16, 2014

Viztek LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K142919

Trade/Device Name: EXATM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2014 Received: November 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.

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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 A. 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)

K142919

Device Name EXATM

Indications for Use (Describe)

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)

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FOR FDA USE ONLY

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

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510(k) Summary, 510(k) Number K142919 Viztek, LLC. 6950 Philips Hwy Jacksonville, FL 32216 Phone: 800.366.5343, Fax: 904.448.9936 Date Prepared: November 3, 2014 Contact: Josip Cermin, President

1. Identification of the Device: Proprietary-Trade Name: EXA™ Classification Name: Picture Archiving and Communications System Product Code LLZ Regulation 892.2250 Common/Usual Name: PACS System
1. Equivalent legally marketed device: Viztek OPAL-RAD™ (K063337).
1. Indications for Use (intended use). EXA™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, nurses, and technicians.
1. Description of the Device: EXA™ is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities, and offer an interface that users find to be quite intuitive after some initial learning. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ RAD suite.
1. Safety and Effectiveness, comparison to predicate device. The results of software validation and comparison to our predicate device indicates that the new device is as safe and effective as our predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.
1. Substantial Equivalence Chart Follows

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Characteristic	Viztek OPAL-RAD™ (K063337).	EXA™ K142919 (This submission)
Intended Use:	Opal-RAD™ is a software device that	EXA™ is a software device that receives
	receives digital images and data from	digital images and data from various sources
(Unchanged)	various sources (i.e. CT scanners, MR	(i.e. CT scanners, MR scanners, ultrasound
The indications statement	scanners, ultrasound systems, R/F Units,	systems, R/F Units, computed & direct
is unchanged from our	computed & direct radiographic devices,	radiographic devices, secondary capture
predicate.	secondary capture devices, scanners,	devices, scanners, imaging gateways or other
	imaging gateways other or imaging	imaging sources). Images and data can be
	sources). Images and data can be stored,	stored, communicated, processed and
	communicated, processed and displayed	displayed within the system and or across
	within the system and or across computer	computer networks at distributed locations.
	networks at distributed locations. Lossy	Lossy compressed mammographic images are
	compressed mammographic images are	not intended for diagnostic review.
	not intended for diagnostic review.	Mammographic images should only be
	Mammographic images should only be	viewed with a monitor cleared by FDA for
	viewed with a monitor approved by FDA	viewing mammographic images. For primary
	for viewing mammographic images. For	diagnosis, post process DICOM "for
	primary diagnosis, post process DICOM	presentation" images must be used. Typical
	"for presentation" images must be used.	users of this system are trained professionals,
	Typical users of this system are trained	nurses, and technicians. (SAME)
	professionals, nurses, and technicians.
Configuration	This submission is Software only	SAME
Film Digitizer	Part of the system	NO
DICOM	Yes	Yes
Compression	Wavelet/JPEG2000	SAME
Improvements to perform	NO	YES,• The ability to rotate of MIP in MPR mode was the added function.• Verify Multiplanar reconstruction
Imaging work
Expanded GUI interface to	NO	YES, Expanded GUI Interface for users-changes to allow client EXA to function with Web
integrate more effectively
with the WEB
Language Capability	NO	YES, Ability to use multilingual interface toclient's operating system (i.e foreign country multi-language translation from English).Allows interpretation of Spanish andPortuguese


Worklist Expansion	NO	YES, Web Work list- includes most of the
- WEB Worklist		advanced study list features and the entire
- Client Worklist		Image Viewing features, but cannot create
		Patient CDs or Import images and scanned
		documents. Verify Client Worklist- Includes
		all the advanced Study List and Image
		Viewing features mentioned above. Available
		modules in the client worklist provide the
		following: Sending and Receiving images
		over phone line, local area networks and the
		Internet. Included in this includes DICOM
		transmission/receive.
Verify PACS Backend -	NO	YES, Ability to add clarity to DICOM images
DICOM Improvements		has been allowed
Improvements to Panel	NO	YES
Guide PACS – UAI
Multifunctional Interface
Characteristic	Viztek OPAL-RAD™ (K063337).	EXA™ K142919 (This submission)
Module Updates	NO	YES,Peer Review-Allows a radiologist to review a report from a second radiologist Exam Report Module functions per specification
Computer	PC	SAME
Power source	AC Line (PC Required)	AC Line (PC Required)

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1. Summary of Bench Testing Conducted: Software Verification and Validation was performed.. Risk Analysis was conducted. The testing showed that the device meets its predetermined Software Requirements Specifications.
1. Summary of Clinical Testing: Not applicable. The software acquires images via a DICOM network connection from FDA cleared imaging devices.
1. Conclusion: After analyzing software validation and risk analysis, it is the conclusion of Viztek Inc that the EXA™ 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

§ 892.2050 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).