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 trained radiologists 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 flaq 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.

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.

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) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, installed on the radiologist' 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 triage and prioritization by the attending radiologist. 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, lowquality, 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.

Presenting the radiologist 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

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity $\ge$ 80%	90.5% (95% CI: 81.4%, 96.2%)
Specificity $\ge$ 80%	88.7% (95% CI: 83.3%, 92.8%)

Study Details

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

Test Set Sample Size: 268 cases (74 positive, 194 negative)
Data Provenance: Retrospective, from 2 clinical study sites in the US.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions "reviewers" identified cases as positive, implying expert review.

4. Adjudication method for the test set:

The document does not specify an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It only mentions that positive cases were "identified as positive both by the reviewers as well as the BriefCase device" when discussing the time-to-notification metric, implying expert consensus or a similar process for ground truth.

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:

Was a MRMC study done? No, a traditional MRMC comparative effectiveness study was not explicitly described. The study focused on the standalone performance of the AI and a comparison of time-to-notification (AI) versus time-to-exam-open (standard of care).
Effect size of human reader improvement: While not an MRMC study measuring reader improvement, the secondary endpoint evaluated the potential clinical benefit of worklist prioritization. The study found a statistically significant mean difference of 220.9 minutes (95% CI: 122.0-319.9; Median: 63.2, IQR: 219.8) between the standard of care time-to-exam-open (223.3 minutes) and the BriefCase time-to-notification (4.7 minutes) for true positive iPE cases. This suggests that if radiologists act on notifications, they could potentially review critical cases hours earlier than without the AI.

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

Yes, a standalone performance evaluation of the algorithm was conducted, reporting sensitivity and specificity metrics against the established ground truth.

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

The ground truth for the test set was established by "reviewers" who identified cases with incidental Pulmonary Embolism (iPE). This strongly implies expert consensus or expert review as the method for ground truth determination.

8. The sample size for the training set:

The document does not explicitly state the sample size for the training set. It mentions the "algorithm programmed component" and "training of the algorithm on iPE," but not the specific number of cases or how they were used for training.

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

The document does not specify how the ground truth for the training set was established. It only notes that the subject device's algorithm differed from the predicate device's due to its "training...on iPE images." This implies that training data also had established ground truth for iPE, likely through similar expert review processes.

Summary

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August 26, 2020

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

Re: K201020

Trade/Device Name: BriefCase for iPE Triage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer-assisted triage and notification software Regulatory Class: Class II Product Code: QAS Dated: July 24, 2020 Received: July 24, 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.

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devices or postmarketing 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) K201020

Device Name

BriefCase for iPE Triage

Indications for Use (Describe)

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 trained radiologists 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 singleenergy exams. The device is intended to work with GE and Siemens scanners only.

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.

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)

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510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K201020)

Submitter:

Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, IsraelPhone:	+972-73-7946870
Contact Person:	N. Epstein, Ph.D.
Date Prepared:	July 24, 2020
Name of Device:	BriefCase for iPE Triage
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 (K190072, for PE)

Device Description

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not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

Intended Use / Indications for Use

Comparison of Technological Characteristics

The subject BriefCase for iPE triage and predicate device BriefCase for PE triage (K190072) are identical in all aspects and defer only with respect to the training of the algorithm on iPE and PE images, respectively. .

Both devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence algorithms incorporated software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations. Both devices are intended to aid in triage and prioritization of radiological images. The predicate device processes CTPAs and is indicated for Pulmonary Embolism triage, while the subject device processes contrast-enhanced chest images and is indicated for incidental Pulmonary Embolism (iPE) triage. Both devices are intended to provide radiologists with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage.

Both software devices notify the attending radiologist of the availability of time sensitive radiological images for review based on computer aided image analysis. Both devices send notifications and low-quality compressed previews to the radiology workstations' desktop. Both devices feature a notification filter in the user interface. Notifications are for informational purpose only and are meant to prompt the radiologist to start preemptive triage of a flagged case, upon which he may decide after observing the unannotated, low quality preview on his desktop, to turn to the local PACS to perform evaluation of the original series earlier than would have been the case in the standard of care alone.

Thus, the subject and predicate BriefCase raise the same types of safety and effectiveness

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questions, namely, accurate detection of findings within the processed study. It is important to note that, like the predicate, the subject device does not remove cases from the standard of care reading queue and does not modify them. Both devices operate in parallel with the standard of care, which remains the default option for all cases.

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

Table 1. Key feature comparison
	Predicate DeviceAidoc Briefcase for PE triage(K190072)	Subject DeviceAidoc Briefcase for iPE triage(K201020)
Intended Use /Indications for Use	BriefCase is a radiologicalcomputer aided triage andnotification software indicated foruse in the analysis of CTPAimages. The device is intendedto assist hospital networks andtrained radiologists in workflowtriage by flagging andcommunication of suspectedpositive findings of PulmonaryEmbolism (PE) pathology. Thesoftware is only intended to beused on single-energy exams.BriefCase uses an artificialintelligence algorithm to analyzeimages and highlight cases withdetected findings on astandalone desktop application inparallel to the ongoingstandard of care imageinterpretation. The user ispresented 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 inconjunction with otherpatient information and based onprofessional judgment, to assistwith triage/prioritization ofmedical images. Notifiedclinicians are responsible forviewing full images per thestandard of care.	BriefCase is a radiologicalcomputer aided triage andnotification software indicated foruse in the analysis of contrast-enhanced chest CTs (but notdedicated CTPA protocol).The device is intended toassist hospital networks andtrained radiologists in workflowtriage by flagging andcommunication of suspectedpositive cases of incidentalPulmonary Embolism (iPE)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 cases ona standalone desktop applicationin parallel to the ongoingstandard of care imageinterpretation. The user ispresented with notifications forsuspect cases. Notificationsinclude compressed previewimages that aremeant for informational purposesonly and not intended fordiagnostic use beyond notification.The device does not alter theoriginal medical image and is notintended to be used as adiagnostic 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 are
	Predicate Device	Subject Device
	Aidoc Briefcase for PE triage(K190072)	Aidoc Briefcase for iPE triage(K201020)
		responsible for viewing full imagesper the standard of care.
User population	Radiologist	Radiologist
Anatomical region ofinterest	Chest	Chest
Inclusion/Exclusion criteria	Inclusion Criteria- CTPA protocols.- Single energy exams.- Scans performed with 64-slice scanner or greaternumber of detectors.- Scans performed onadults/transitional adults ≥ 18years of age.- Slice thickness 0.5 - 3.0 mmaxial.Exclusion Criteria- All studies that are technicallyinadequate, including studieswith motion artifacts, severemetal artifacts, sub-optimalbolus or inadequate field ofview.	Inclusion criteria- Contrast-enhanced chest CTs(but not dedicated CTPAprotocol.- Single energy exams.- Scans performed with a 64slice or greater number ofdetectors.- Scans performed onadults/transitional adults ≥ 18years of age.- Slice thickness: 0.5mm -2.0mm axial.Exclusion Criteria- All studies that are technicallyinadequate, including studieswith motion artifacts, severemetal artifacts, or inadequatefield of view.
Data acquisitionprotocol	CTPA protocol	Contrast-enhanced chest CTs (butnot dedicated CTPA protocol)
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' attentionto a specific location in the originalimage
Algorithm	Artificial intelligence algorithmwith database of images	Artificial intelligence algorithm withdatabase 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 of care,which remains the default optionfor all cases. Unflagged casesare not de-prioritized.	No. The device operates inparallel with the standard of care,which remains the default optionfor all cases. Unflagged cases arenot de-prioritized.
	Predicate DeviceAidoc Briefcase for PE triage(K190072)	Subject DeviceAidoc Briefcase for iPE triage(K201020)
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 application forworkflow integration (worklistand non-diagnostic basicImage Viewer).

Table 1. Kev feature comparison

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Performance Data

Pivotal Study Summary

Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying Contrast-enhanced chest CTs (but not dedicated CTPA protocol), containing Incidental Pulmonary Embolism in 268 cases from 2 clinical study sites in the US. There were 74 positive cases and 194 negative cases (images with iPE versus without iPE) included in the analysis.

Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was 90.5% (95% Cl: 81.4%, 96.2%) and specificity was 88.7% (95% Cl: 83.3%, 92.8%).

Secondary Endpoint

Briefcase's potential clinical benefit of worklist prioritization for true positive iPE cases was evaluated by comparing the standard-of-care metric of time-to-exam-open to the software's timeto-notification metric for iPE, in the study sites where the time-to-exam-open information was available.

-The BriefCase time-to-notification includes the time to get the DICOM exam, de-identify it, upload it to the cloud, analyze and send a notification on a positive suspect case back to the worklist application.
-The standard of care time-to-open-exam consists of the from scan acquisition to when the radiologist first opened the exam for review.

The standard of care metric was compared to the BriefCase time-to-notification in the two study sites (both in the US) for 63 True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase device), and the results are reported in the Table 2 below.

The BriefCase time-to-notification for iPE was 4.7 minutes (95% Cl: 4.4-5.1; Median: 5.0, IQR: 2.3). In contrast, standard of care time-to-exam-open was much longer, 223.3 minutes (95% Cl: 125.8-320.7; Median: 70.4, IQR: 217.6). The mean difference of 220.9 minutes (95% Cl: 122.0-319.9; Median: 63.2, IQR: 219.8) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive iPE case and acts on it immediately, it can on average save more than three hours compared to the time-to-exam-open in a first in first out (FIFO) reading queue. The value of 220.9 is based on the study of 63 cases from 2 study sites and may vary in practice.

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Parameter	N	Meanestimate	LowerConfidenceLimit	UpperConfidenceLimit	Median	IQR
Time-to-exam-openin the standard ofcare	63	223.3	125.8	320.7	70.4	217.65
Time-to-notificationBriefCase iPE	63	4.7	4.4	5.1	5.0	2.3
Difference	63	220.9	122.0	319.9	63.2	219.8

Table 2. Time saving data

NPV was 99.7% (95% Cl: 99.5%-99.9%) and PPV was 17.6% (95% Cl: 9.5%-22.1%).

Thus, the reported time savings data demonstrates that radiologists may have the opportunity to be involved in the clinical workflow substantially earlier due to the notifications from the BriefCase device. Performance validation data suggest that when using the subject BriefCase for iPE triage, the radiologists may have the same benefit in time saving as with using the BriefCase for PE triage.

Conclusions

The subject BriefCase for iPE triage and the predicate BriefCase for PE triage devices are both intended to aid in prioritization and triage of radiological images for the indications of incidental Pulmonary Embolism and Pulmonary Embolism respectively. Both devices are software packages with similar technological characteristics and principles of operation, both incorporating deep learning AI algorithms that process images, and software to send notifications and unannotated compressed preview images to the radiologists' workstation. In both devices, the labeling states that the devices are not for diagnostic use and instructs the user to further evaluate and diagnose based only on the original images in the local PACS.

Both devices operate in parallel to the standard of care workflow in the sense that they do not change the original image, do not provide any marking on the output preview, and do not remove images from the standard of care FIFO queue, thus not disturbing standard interpretation of the images by the attending radiologists. Both devices notify the radiologist of time-sensitive critical cases within the range of several minutes, and thus contribute similarly to the standard of care workflow turnaround time reduction through preemptive triage.

The BriefCase device for iPE triage is thus substantially equivalent to the BriefCase for PE triage.

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.