BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.

BriefCase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Haemorrhage (ICH).

BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care..

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE) pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.

BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase are intended to be used in coniunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.

The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. .

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast enhanced chest CT images (but not dedicated CTPA protocol) CT. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Incidental Pulmonary Embolism (iPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device in intended to work with GE and Siemens scanners only.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.

Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL. DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.

The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., CSF). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

Presenting the user with notification facilitates earlier triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

AI/ML Overview

The provided document focuses on the Aidoc Medical, Ltd.'s BriefCase (K203508) device. It discusses the device's indications for use and demonstrates its substantial equivalence to several predicate devices. The key aspect of this submission is the broadening of the intended user population from "radiologists" to "appropriately trained medical specialists".

Crucially, the document explicitly states multiple times (on pages 11, 15, 19, 23, 27, and 32) that "Performance data was not needed to support this modification to BriefCase." This means that a new study was not conducted to demonstrate that the device meets separate acceptance criteria for K203508. Instead, the current submission relies on the performance data of the predicate devices (K190896, K180647, K190072, K193298, K201020, K192383).

Therefore, I cannot provide a table of acceptance criteria and reported device performance for K203508, nor information about a specific study proving it meets these criteria, as such a study was not performed for this specific submission according to the document. The document's argument for substantial equivalence is based on the identical intended use, technological characteristics, and principles of operation, with the only change being the expanded user population, which the FDA agrees does not raise new questions of safety or effectiveness.

However, I can extract the information related to the performance data that was used to support the initial clearance of the predicate devices, as indicated by the document. For instance, the summaries mention:

"The 510(k) Summary for K190896 describes the data that was used to support initial clearance of BriefCase." (page 11)
"The 510(k) Summary for K180647 describes the data that was used to support initial clearance of BriefCase." (page 15)
Similarly for K190072 (page 19), K193298 (page 23), K201020 (page 27), and K192383 (page 32).

Without access to the actual 510(k) Summaries for these predicate devices (e.g., K190896, K180647 etc.), I cannot describe the detailed acceptance criteria and the performance studies that originally cleared those devices. The provided document is a notification of intent to market a device based on substantial equivalence, not a summary of a new performance study.

In summary, based on the provided text, the answer to your request regarding K203508 is that a new study was not performed, as the submission argues for substantial equivalence based on a broadened user population rather than a change requiring new performance data.

Summary

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December 29, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW WASHINGTON DC 20004

Re: K203508

Trade/Device Name: BriefCase Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: November 30, 2020 Received: November 30, 2020

Dear Dr. Smith:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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

for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K203508

Device Name

BriefCase

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)

CONTINUE ON A SEPARATE PAGE IF NEEDEDThis 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.qov

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

510(k) Number (if known)

K203508 Device Name

BriefCase

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

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

510(k) Number (if known)

K203508

Device Name

BriefCase

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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."

{5}------------------------------------------------

510(k) Number (if known) K203508 Device Name

BriefCase

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{6}------------------------------------------------

510(k) Number (if known) K203508 Device Name

BriefCase

Indications for Use (Describe)

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

| Z Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{7}------------------------------------------------

510(k) Number (if known) K203508 Device Name

BriefCase

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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

{8}------------------------------------------------

510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K203508)

Submitter:	Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, Israel
Phone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	December 17, 2020
Name of Device:	BriefCase
Classification Name:	Radiological computer-assisted triage and notification softwaredevice
Regulatory Class:	Class II
Product Code:	QAS (21 C.F.R. 892.2080)
Predicate Device:	BriefCase (K190896)

Device Description

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Intended Use / Indications for Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of linear lucencies in the cervical spine bone in patterns compatible with fractures.

Substantial Equivalence

The subject and predicate devices have an identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.

A table comparing the key features of the subject and predicate devices is provided below.

	Predicate Device	Subject Device
	Aidoc Briefcase (K190896)	Aidoc Briefcase (K203508)
Intended Use / Indications forUse	BriefCase is a radiologicalcomputer aided triage andnotification software indicated foruse in the analysis of cervicalspine CT images. The device isintended to assist hospitalnetworks and trained radiologistsin workflow triage by flaggingand communication of suspectedpositive findings of linearlucencies in the cervical spinebone in patterns compatible withfractures.	BriefCase is a radiologicalcomputer aided triage andnotification software indicated foruse in the analysis of cervicalspine CT images. The device isintended to assist hospitalnetworks and appropriatelytrained medical specialists inworkflow triage by flagging andcommunication of suspectedpositive findings of linearlucencies in the cervical spinebone in patterns compatible withfractures.
	BriefCase uses an artificialintelligence algorithm to analyzeimages and highlight cases withdetected findings on astandalone desktop applicationin parallel to the ongoingstandard of care imageinterpretation. The user ispresented with notifications for	BriefCase uses an artificialintelligence algorithm to analyzeimages and highlight cases withdetected findings on astandalone desktop applicationin parallel to the ongoingstandard of care imageinterpretation. The user is
	Predicate Device	Subject Device
	Aidoc Briefcase (K190896)	Aidoc Briefcase (K203508)
	cases with suspected findings.Notifications include compressedpreview images that are meantfor informational purposes onlyand not intended for diagnosticuse beyond notification. Thedevice does not alter the originalmedical image and is notintended to be used as adiagnostic device.The results of BriefCase areintended to be used in	presented with notifications forcases with suspected findings.Notifications include compressedpreview images that aremeant for informational purposesonly and not intended fordiagnostic usebeyond notification. The devicedoes not alter the originalmedical image and is notintended to be used as adiagnostic device.The results of BriefCase areintended to be used in
	conjunction with other patientinformation and based on theirprofessional judgment, to assistwith triage/prioritization ofmedical images. Notifiedclinicians are responsible forviewing full images per thestandard of care.	conjunction with otherpatient information and based ontheir professional judgment, toassist with triage/prioritization ofmedical images. Notifiedclinicians are responsible forviewing full images per thestandard of care.
User population	Radiologist	Appropriately trained medicalspecialists
Anatomical region of interest	Cervical spine	Cervical spine
Data acquisition protocol	Non-contrast cervical spine CTscan	Non-contrast cervical spine CTscans
View DICOM data	DICOM Information about thepatient, study and current image	DICOM Information about thepatient, study and current image
Segmentation of region ofinterest	No; device does not mark,annotate, or direct users'attention to a specific location inthe original image	No; device does not mark,annotate, or direct users'attention to a specific location inthe original image
Algorithm	Artificial intelligence algorithmwith database of images	Artificial intelligence algorithmwith database of images
Notification/Prioritization	Yes	Yes
Preview images	Presentation of a small,compressed, black and whitepreview image that is labeled"Not for diagnostic use";The device operates in parallelwith the standard of care, whichremains the default option for allcases.	Presentation of a small,compressed, black and whitepreview image that is labeled"Not for diagnostic use";The device operates in parallelwith the standard of care, whichremains the default option for allcases.
Alteration of original image	No	No
Removal of cases from worklist	No	No

Table 1. Key feature comparison

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Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K190896 describes the data that was used to support initial clearance of BriefCase.

Conclusions

The subject BriefCase is as safe and effective as the predicate BriefCase, with the same intended use, technological characteristics, and principles of operation. Broadening the intended user population does not raise new or different questions of safety or effectiveness.

{12}------------------------------------------------

510(k) Summary

Aidoc Medical, Ltd.'s BriefCase (K203508)

Submitter:

Aidoc Medical, Ltd.3 Aminadev St.Tel-Aviv, IsraelPhone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	December 17, 2020
Name of Device:	BriefCase
Classification Name:	Radiological computer aided triage and notification software
Regulatory Class:	Class II
Product Code:	QAS (21 C.F.R. 892.2080)
Predicate Device:	Aidoc Medical BriefCase (K180647)
Reference Device:	Qure.ai Technologies qER (K200921)

Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.

DICOM images are received, saved and filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.

The Worklist Application displays the pop-up notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name and accession number. A list of all incoming cases with suspected findings is also displayed. In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the user with notification facilitates earlier triage by allowing one to assess the available images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

{13}------------------------------------------------

Intended Use / Indications for Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images.

The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH).

The results of BriefCase are intended to be used in conjunction with other patient information and based on professional judgment. to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Substantial Equivalence

The subject and predicate devices have identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide notifications and preview head images of potential findings to the user for the purpose of treatment planning and follow up, and are therefore substantially equivalent. The reference qER device is also intended for use by trained medical specialists.

A table comparing the key features of the subject and predicate devices is provided below.

	Subject Device	Predicate Device
	Aidoc Briefcase (K203508)	Aidoc Briefcase (K180647)
Intended Use / Indications forUse	BriefCase is a radiologicalcomputer aided triage andnotification softwareindicated for use in theanalysis of non-enhancedhead CT images.	BriefCase is a radiologicalcomputer aided triage andnotification softwareindicated for use in theanalysis of non-enhancedhead CT images.
	The device is intended toassist hospital networks andappropriately trained medicalspecialist in workflow triageby flagging andcommunication of suspectedpositive findings ofpathologies in head CTimages, namely IntracranialHemorrhage (ICH).	The device is intended toassist hospital networks andtrained radiologists inworkflow triage by flaggingand communication ofsuspected positive findingsof pathologies in head CTimages, namely IntracranialHemorrhage (ICH).
	BriefCase uses an artificial	BriefCase uses an artificialintelligence algorithm to
	intelligence algorithm to	analyze images and highlight
	Subject Device	Predicate Device
	Aidoc Briefcase (K203508)	Aidoc Briefcase (K180647)
	analyze images and highlightcases with detected ICH on astandalone desktopapplication in parallel to theongoing standard of careimage interpretation. Theuser is presentedwith notifications for caseswith suspected ICH findings.Notificationsinclude compressed previewimages that aremeant for informationalpurposes only and notintended for diagnostic usebeyond notification. Thedevice does not alter theoriginal medical image and isnot intended to be used as adiagnostic device.	cases with detected ICH on astandalone desktopapplication in parallel to theongoing standard of careimage interpretation. Theuser is presentedwith notifications for caseswith suspected ICH findings.Notificationsinclude compressed previewimages that aremeant for informationalpurposes only and notintended for diagnostic usebeyond notification. Thedevice does not alter theoriginal medical image and isnot intended to be used as adiagnostic device.
	The results of BriefCase areintended to be used inconjunction with otherpatient information andbased on professionaljudgment, to assist withtriage/prioritization of medicalimages. Notifiedclinicians are responsible forviewing full images per thestandard of care.	The results of BriefCase areintended to be used inconjunction with otherpatient information andbased on professionaljudgment, to assist withtriage/prioritization of medicalimages. Notifiedclinicians are responsible forviewing full images per thestandard of care.
User population	Appropriately trained medicalspecialist	Radiologist
Anatomical region of interest	Head	Head
Data acquisition protocol	Non contrast CT scan of thehead or neck	Non contrast CT scan of thehead or neck
View DICOM data	DICOM Information aboutthe patient, study and currentimage	DICOM Information aboutthe patient, study and currentimage
Segmentation of region ofinterest	No; device does not mark,highlight, or direct users'attention to a specificlocation in the original image	No; device does not mark,highlight, or direct users'attention to a specificlocation in the original image
Algorithm	Artificial intelligencealgorithm with database ofimages	Artificial intelligencealgorithm with database ofimages
Notification/Prioritization	Yes	Yes
Preview images	Presentation of a preview ofthe study for initialassessment not meant fordiagnostic purposesThe device operates in	Presentation of notificationand preview of the study forinitial assessment not meantfor diagnostic purposesThe device operates in
	parallel with the standard of	parallel with the standard of
	Subject Device	Predicate Device
	Aidoc Briefcase (K203508)	Aidoc Briefcase (K180647)
	care, which remains thedefault option for all cases	care, which remains thedefault option for all cases
Alteration of original image	No	No
Removal of cases fromworklist queue	No	No

Table 1. Key feature comparison

{14}------------------------------------------------

{15}------------------------------------------------

Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K180647 describes the data that was used to support initial clearance of BriefCase.

Conclusions

{16}------------------------------------------------

510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K203508)

Submitter:

Aidoc Medical, Ltd.3 Aminadev St.Tel-Aviv, IsraelPhone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	December 17, 2020
Name of Device:	BriefCase
Classification Name:	Radiological computer-assisted triage and notification softwaredevice
Requlatory Class:	Class II
Product Code:	QAS (21 C.F.R. 892.2080)
Predicate Device:	BriefCase (K190072)

Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.

The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., PE). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

{17}------------------------------------------------

Intended Use / Indications for Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE) pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.

Substantial Equivalence

The subject and predicate device have identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.

A table comparing the key features of the subject and predicate devices is provided below.

	Predicate Device	Subject Device
	Aidoc Briefcase (K190072)	Aidoc Briefcase (K203508)
Intended Use /Indications for Use	BriefCase is a radiologicalcomputer aided triage andnotification software indicatedfor use in the analysis of non-enhanced head CT and CTPAimages. The device is intendedto assist hospital networks andtrained radiologists in workflowtriage by flagging andcommunication of suspectedpositive findings of IntracranialHemorrhage (ICH) andPulmonary Embolism (PE)pathologies. For the PEpathology, the software is onlyintended to be used on single-energy exams.	BriefCase is a radiologicalcomputer aided triage andnotification software indicatedfor use in the analysis of non-enhanced head CT and CTPAimages. The device is intendedto assist hospital networks andappropriately trained medicalspecialists in workflow triageby flagging and communicationof suspected positive findings ofIntracranial Hemorrhage (ICH) andPulmonary Embolism (PE)pathologies. For the PEpathology, the software is onlyintended to be used on single-energy exams.
	BriefCase uses an artificialintelligence algorithm toanalyze images and highlightcases with detected findings on	BriefCase uses an artificialintelligence algorithm toanalyze images and highlightcases with detected findings on
	Predicate DeviceAidoc Briefcase (K190072)	Subject DeviceAidoc Briefcase (K203508)
	a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.	a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
User population	Radiologist	Appropriately trained medical specialists
Anatomical region of interest	Head and chest	Head and chest
Data acquisition protocol	Non-contrast head CT scan and CTPA (single energy exams only)	Non-contrast head CT scan and CTPA (single energy exams only)
View DICOM data	DICOM Information about the patient, study and current image	DICOM Information about the patient, study and current image
Segmentation of region of interest	No; device does not mark, annotate, or direct users' attention to a specific location in the original image	No; device does not mark, annotate, or direct users' attention to a specific location in the original image
Algorithm	Artificial intelligence algorithm with database of images	Artificial intelligence algorithm with database of images
Notification/Prioritization	Yes	Yes
Preview images	Presentation of a small, compressed, black and white preview image that is labeled "Not for diagnostic use"; The device operates in parallel with the standard of care, which remains the default option for all cases.	Presentation of a small, compressed, black and white preview image that is labeled "Not for diagnostic use"; The device operates in parallel with the standard of care, which remains the default option for all cases.
	Predicate DeviceAidoc Briefcase (K190072)	Subject DeviceAidoc Briefcase (K203508)
Alteration of originalimage	No	No
Removal of cases fromworklist queue	No	No

Table 1. Key feature comparison

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{19}------------------------------------------------

Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K190072 describes the data that was used to support initial clearance of BriefCase.

Conclusions

{20}------------------------------------------------

510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K203508)

Submitter:

Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, IsraelPhone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	December 17, 2020
Name of Device:	BriefCase
Classification Name:	Radiological computer-assisted triage and notification softwaredevice
Regulatory Class:	Class II
Product Code:	QAS (21 C.F.R. 892.2080)
Predicate Device:	BriefCase (K193298)

Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.

DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization. The user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVO) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.

The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., IFG). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

{21}------------------------------------------------

Intended Use / Indications for Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected findings of Intra-abdominal Free Gas (IFG) pathologies.

Substantial Equivalence

A table comparing the key features of the subject and predicate devices is provided below.

Table 1. Key feature comparison
	Predicate DeviceAidoc Briefcase (K193298)	Subject DeviceAidoc Briefcase (K203508)
Intended Use / Indicationsfor Use	BriefCase is a radiologicalcomputer aided triage andnotification software indicated foruse in the analysis of abdominalCT images. The device is intendedto assist hospital networks andtrained radiologists in workflowtriage by flagging andcommunication of suspectedpositive findings of Intra-abdominalFree Gas (IFG) pathologies.BriefCase uses an artificialintelligence algorithm to analyzeimages and highlight cases withdetected findings on a standalonedesktop application in parallel to	BriefCase is a radiologicalcomputer aided triage andnotification software indicatedfor use in the analysis ofabdominal CT images.The device is intended toassist hospital networks andappropriately trained medicalspecialists in workflow triageby flagging and communicationof suspected positive findingsof Intra-abdominal Free Gas(IFG) pathologies.BriefCase uses an artificialintelligence algorithm toanalyze images and highlight
	Predicate DeviceAidoc Briefcase (K193298)	Subject DeviceAidoc Briefcase (K203508)
	the ongoing standard of careimage interpretation. The user ispresented with notifications forcases with suspected findings.Notifications include compressedpreview images that are meant forinformational purposes only andnot intended for diagnostic usebeyond notification. The devicedoes not alter the original medicalimage and is not intended to beused as a diagnostic device.The results of BriefCase areintended to be used in conjunctionwith other patient information andbased on their professionaljudgment, to assist withtriage/prioritization of medicalimages. Notified clinicians areresponsible for viewing full imagesper the standard of care.	cases with detected findings ona standalone desktopapplication in parallel to theongoing standard of careimage interpretation. The useris presented with notificationsfor cases with suspectedfindings. Notificationsinclude compressed previewimages that aremeant for informationalpurposes only and not intendedfor diagnostic usebeyond notification. The devicedoes not alter the originalmedical image and is notintended to be used as adiagnostic device.The results of BriefCase areintended to be used inconjunction with otherpatient information and basedon their professionaljudgment, to assist withtriage/prioritization of medicalimages. Notified clinicians areresponsible for viewingfull images per the standard ofcare.
User population	Radiologist	Appropriately trained medicalspecialists
Anatomical region ofinterest	Abdomen	Abdomen
Data acquisition protocol	Abdominal CT scan	Abdominal CT scan
View DICOM data	DICOM Information about thepatient, study and current image	DICOM Information about thepatient, study and currentimage
Segmentation of region ofinterest	No; device does not mark,annotate, or direct users' attentionto a specific location in the originalimage	No; device does not mark,annotate, or direct users'attention to a specific locationin the original image
Algorithm	Artificial intelligence algorithm withdatabase of images	Artificial intelligence algorithmwith database of images
Notification/Prioritization	Yes	Yes
Preview images	Presentation of a small,compressed, black and whitepreview image that is labeled "Notfor diagnostic use";The device operates in parallelwith the standard of care, whichremains the default option for allcases.	Presentation of a small,compressed, black and whitepreview image that is labeled"Not for diagnostic use";The device operates in parallelwith the standard of care,which remains the defaultoption for all cases.
Alteration of original image	No	No
	Predicate DeviceAidoc Briefcase (K193298)	Subject DeviceAidoc Briefcase (K203508)
Removal of cases fromworklist queue	No	No

{22}------------------------------------------------

{23}------------------------------------------------

Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K193298 describes the data that was used to support initial clearance of BriefCase.

Conclusions

{24}------------------------------------------------

510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K203508)

Submitter:

Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, IsraelPhone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	December 17, 2020
Name of Device:	BriefCase
Classification Name:	Radiological computer-assisted triage and notification softwaredevice
Requlatory Class:	Class II
Product Code:	QAS (21 C.F.R. 892.2080)
Predicate Device:	BriefCase (K201020)

Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.

DICOM images are received, saved, filtered and de-identified before processing. Filtration matches metadata fields with keywords. Series are processed chronologically by running the algorithms on each series to detect suspected cases. The software then flags suspect cases by sending notifications to the Worklist desktop application, thereby prompting preemptive triaqe and prioritization by the user . As the BriefCase software platform harbors several triage algorithms, the user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on LVO cases, and a neuro-radiologist would opt to divert PE notifications. Where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.

The Worklist Application displays the pop-up text notifications of new suspected studies when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., iPE). A list of all incoming suspect cases is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

{25}------------------------------------------------

Intended Use / Indications for Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (but not dedicated CTPA protocol). The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device is intended to work with GE and Siemens scanners only.

BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

Substantial Equivalence

Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.

A table comparing the key features of the subject and predicate devices is provided below.

Table 1. Kev feature comparison

{26}------------------------------------------------

{27}------------------------------------------------

Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K201020 describes the data that was used to support initial clearance of BriefCase.

{28}------------------------------------------------

Conclusions

{29}------------------------------------------------

510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K203508)

Submitter:

Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, IsraelPhone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	December 17, 2020
Name of Device:	BriefCase
Classification Name:	Radiological computer-assisted triage and notification softwaredevice
Requlatory Class:	Class II
Product Code:	QAS (21 C.F.R. 892.2080)
Primary Predicate Device:	BriefCase (K192383)

Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-theshelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the user's desktop and provides the user interface in which notifications from the BriefCase software are received.

The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., LVO). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

{30}------------------------------------------------

Intended Use / Indications for Use

Substantial Equivalence

The subject and predicate devices have an identical intended use, technological characteristics, and principles of operation. The only difference is that the subject device has a broadened intended use population of appropriately trained medical specialists, whereas the predicate device is indicated for use by radiologists. Both devices are intended to provide the users with notifications and unannotated low-quality preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent.

A table comparing the key features of the subject and predicate devices is provided below.

Table 1. Key feature comparison
	Subject Device	Predicate Device
	Aidoc Briefcase (K203508)	Aidoc Briefcase (K192383)
Intended Use / Indications forUse	BriefCase is a radiologicalcomputer aided triage andnotification software indicatedfor use in the analysis of headCTA images. The device isintended to assist hospitalnetworks and appropriatelytrained medical specialists inworkflow triage by flaggingand communication ofsuspected positive findings ofLarge Vessel Occlusion (LVO)pathologies.	BriefCase is a radiologicalcomputer aided triage andnotification soft-ware indicatedfor use in the analysis of headCTA images. The device isintended to assist hospitalnetworks and trained medicalspecialists in workflow triageby flagging andcommunication of suspectedpositive findings of LargeVessel Occlusion (LVO)pathologies.
	Subject DeviceAidoc Briefcase (K203508)	Predicate DeviceAidoc Briefcase (K192383)
	cases with detected findingson a standalone desktopapplication in parallel to theongoing standard of careimage interpretation. The useris presented with notificationsfor cases with suspectedfindings. Notificationsinclude compressed previewimages that aremeant for informationalpurposes only and notintended for diagnostic usebeyond notification. Thedevice does not alter theoriginal medical image and isnot intended to be used as adiagnostic device.	cases with detected findingson a standalone desktopapplication in parallel to theongoing standard of careimage interpretation. The useris presented with notificationsfor cases with suspectedfindings. Notifications includecompressed preview imagesthat are meant forinformational purposes onlyand not intended fordiagnostic use beyondnotification. The device doesnot alter the original medicalimage and is not intended tobe used as a diagnosticdevice.
	The results of BriefCase areintended to be used inconjunction with otherpatient information and basedon their professionaljudgment, to assist withtriage/prioritization of medicalimages. Notified clinicians areresponsible for viewingfull images per the standard ofcare.	The results of BriefCase areintended to be used inconjunction with other patientinformation and based on theirprofessional judgment, toassist with triage/prioritizationof medical images. Notifiedclinicians are responsible forviewing full images per thestandard of care.
User population	Appropriately trained medicalspecialists	Radiologist
Anatomical region of interestInclusion/Exclusion criteria	HeadInclusion criteriaHead CTA protocol with a64-slice scanner or higher;Scans performed onadults/transitional adults ≥18 years of age;Slice thickness 0.5 mm -1.0 mm.	HeadInclusion CriteriaHead CTA protocol with a64-slice scanner or higher;Scans performed onadults/transitional adults ≥18 years of age;Slice thickness 0.5 mm -1.0 mm.
	Exclusion CriteriaAll scans that aretechnically inadequate,including motion artifacts,severe metal artifacts, sub-optimal bolus timing or aninadequate field of view.	Exclusion CriteriaAll scans that aretechnically inadequate,including motion artifacts,severe metal artifacts, sub-optimal bolus timing or aninadequate field of view.
	Subject DeviceAidoc Briefcase (K203508)	Predicate DeviceAidoc Briefcase (K192383)
View DICOM data	DICOM Information about thepatient, study and currentimage	DICOM Information about thepatient, study and currentimage
Segmentation of region ofinterest	No; device does not mark,annotate, or direct users'attention to a specific locationin the original image.	No; device does not mark,annotate, or direct users'attention to a specific locationin the original image.
Algorithm	Artificial intelligence algorithmwith database of images.	Artificial intelligence algorithmwith database of images.
Notification/Prioritization	Yes	Yes
Preview images	Presentation of a small,compressed, black and whitepreview image that is labeled"Not for diagnostic use";The device operates inparallel with the standard ofcare, which remains thedefault option for all cases.	Presentation of a small,compressed, black and whitepreview image that is labeled"Not for diagnostic use";The device operates inparallel with the standard ofcare, which remains thedefault option for all cases.
Alteration of original image	No	No
Removal of cases fromworklist queue	No	No
Structure	- AHS module (image acquisition);- ACS module (image processing);- Aidoc Worklist applicationfor workflow integration(worklist and ImageViewer).Addition of minor changes inthe software platform, e.g.notification filter, whichneither impacts the order inwhich notification come in,nor affects the safety andefficacy profile of the device	- AHS module (image acquisition);- ACS module (image processing);- Aidoc Worklist applicationfor workflow integration(worklist and ImageViewer).Addition of minor changes inthe software platform, e.g.notification filter, whichneither impacts the order inwhich notification come in,nor affects the safety andefficacy profile of the device

Table 1. Kev feature comparison

{31}------------------------------------------------

{32}------------------------------------------------

Performance data was not needed to support this modification to BriefCase. The 510(k) Summary for K192383 describes the data that was used to support initial clearance of BriefCase.

Conclusions

Regulation Number and Section

§ 892.2080 Radiological computer aided triage and notification software.

(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

Table 1. Key feature comparison
	Predicate DeviceAidoc Briefcase (K201020)	Subject DeviceAidoc Briefcase (K203508)
Intended Use /Indications for Use	BriefCase is a radiologicalcomputer aided triage andnotification software indicatedfor use in the analysis ofcontrast-enhanced chest CTs(but not dedicated CTPAprotocol). The device isintended to assist hospitalnetworks and trainedradiologists in workflow triageby flagging and communicationof suspected positive cases ofincidental Pulmonary Embolism(iPE) pathologies. For the iPE	BriefCase is a radiologicalcomputer aided triage andnotification software indicatedfor use in the analysis ofcontrast-enhanced chest CTs(but not dedicated CTPAprotocol). The device isintended to assist hospitalnetworks and appropriatelytrained medical specialists inworkflow triage by flagging andcommunication of suspectedpositive cases of incidentalPulmonary Embolism (iPE)
	Predicate Device	Subject Device
	Aidoc Briefcase (K201020)	Aidoc Briefcase (K203508)
	pathology, the software is onlyintended to be used on single-energy exams. The device isintended to work with GE andSiemens scanners only.	pathologies. For the iPEpathology, the software is onlyintended to be used on single-energy exams. The device isintended to work with GE andSiemens scanners only.
	BriefCase uses an artificialintelligence algorithm to analyzeimages and flag suspect caseson a standalone desktopapplication in parallel to theongoing standard of care imageinterpretation. The user ispresented with notifications forsuspect cases. Notificationsinclude compressed previewimages that are meant forinformational purposes only andnot intended for diagnostic usebeyond notification. The devicedoes not alter the originalmedical image and is notintended to be used as adiagnostic device.The results of BriefCase areintended to be used inconjunction with other patientinformation and based on theirprofessional judgment, to assistwith triage/prioritization ofmedical images. Notifiedclinicians are responsible forviewing full images per thestandard of care.	BriefCase uses an artificialintelligence algorithm toanalyze images and flagsuspect cases on a standalonedesktop application in parallelto the ongoing standard of careimage interpretation. The user ispresented with notificationsfor suspect cases. Notificationsinclude compressed previewimages that aremeant for informationalpurposes only and not intendedfor diagnostic usebeyond notification. The devicedoes not alter the originalmedical image and is notintended to be used as adiagnostic device.The results of BriefCase areintended to be used inconjunction with otherpatient information and basedon their professionaljudgment, to assist withtriage/prioritization of medicalimages. Notified clinicians areresponsible for viewingfull images per the standard ofcare.
User population	Radiologist	Appropriately trained medicalspecialists
Anatomical region ofinterest	Chest	Chest
Inclusion/Exclusion criteria	Inclusion Criteria- Contrast-enhanced chestCTs (but not dedicatedCTPA protocol.- Single energy exams.- Scans performed with a64 slice or greaternumber of detectors.- Scans performed onadults/transitional adults ≥18 years of age.	Inclusion criteria- Contrast-enhanced chestCTs (but not dedicatedCTPA protocol.- Single energy exams.- Scans performed with a 64slice or greater number ofdetectors.- Scans performed onadults/transitional adults ≥18 years of age.
	Predicate DeviceAidoc Briefcase (K201020)	Subject DeviceAidoc Briefcase (K203508)
	Slice thickness: 0.5mm –2.0mm axial.	Slice thickness: 0.5mm –2.0mm axial.
	Exclusion Criteria- All studies that aretechnically inadequate,including studies with motionartifacts, severe metalartifacts, or inadequate fieldof view.	Exclusion Criteria- All studies that aretechnically inadequate,including studies with motionartifacts, severe metalartifacts, or inadequate fieldof view.
Data acquisitionprotocol	Contrast-enhanced chest CTs(but not dedicated CTPAprotocol)	Contrast-enhanced chest CTs(but not dedicated CTPAprotocol)
View DICOM data	DICOM Information about thepatient, study and current image	DICOM Information about thepatient, study and current image
Segmentation of regionof interest	No; device does not mark,annotate, or direct users'attention to a specific location inthe original image	No; device does not mark,annotate, or direct users'attention to a specific location inthe original image
Algorithm	Artificial intelligence algorithmwith database of images	Artificial intelligence algorithmwith database of images
Notification/Prioritization	Yes	Yes
Preview images	Presentation of a low-quality,compressed, grayscale previewimage that is captioned "Not fordiagnostic use".	Presentation of a low-quality,compressed, grayscale previewimage that is captioned "Not fordiagnostic use".
Alteration of originalimage	No	No
Removal of cases fromworklist queue	No. The device operates inparallel with the standard ofcare, which remains the defaultoption for all cases. Unflaggedcases are not de-prioritized.	No. The device operates inparallel with the standard ofcare, which remains the defaultoption for all cases. Unflaggedcases are not de-prioritized.
Structure	- AHS module (imageacquisition).- ACS module (imageprocessing).- Aidoc Worklist application forworkflow integration (worklistand non-diagnostic basicImage Viewer).	- AHS module (imageacquisition).- ACS module (imageprocessing).- Aidoc Worklist applicationfor workflow integration(worklist and non-diagnosticbasic Image Viewer).