K Number
K201020
Device Name
BriefCase
Date Cleared
2020-08-26

(131 days)

Product Code
Regulation Number
892.2080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

Not Found

Yes
The document explicitly states that the device "uses an artificial intelligence algorithm to analyze images" and mentions "deep learning AI algorithms".

No.
A therapeutic device is one that treats or prevents a disease. This device assists radiologists in workflow triage by flagging suspect cases, it does not provide any therapy.

No

The text explicitly states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device." It also clarifies that notifications and preview images are "not intended for diagnostic use beyond notification" and are "meant for informational purposes only." The device's primary function is described as workflow triage and flagging suspect cases for prioritization, with the expectation that notified clinicians will view full images for diagnosis.

Yes

The device description explicitly states that BriefCase is a "radiological computer-assisted triage and notification software device" and details its software components and architecture. There is no mention of accompanying hardware that is part of the medical device itself.

Based on the provided text, the BriefCase device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • BriefCase's Function: BriefCase analyzes medical images (contrast-enhanced chest CTs) that are already acquired from the patient. It does not interact with or analyze biological specimens from the body.
  • Intended Use: The intended use clearly states it's a "radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs". Its purpose is to assist in workflow triage and notification based on image analysis, not the analysis of biological samples.
  • Device Description: The device description details the software components and how it processes DICOM images. There is no mention of handling or analyzing biological specimens.

Therefore, BriefCase falls under the category of a medical device that processes and analyzes medical images, not an In Vitro Diagnostic device.

No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

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 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 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 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.

Product codes

QAS

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

Contrast-enhanced chest CTs (but not dedicated CTPA protocol)

Anatomical Site

Chest

Indicated Patient Age Range

adults/transitional adults ≥ 18 years of age.

Intended User / Care Setting

Hospital networks and trained radiologists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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 study was conducted on 63 True Positive cases from 2 study sites.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: 90.5% (95% Cl: 81.4%, 96.2%)
Specificity: 88.7% (95% Cl: 83.3%, 92.8%)
NPV: 99.7% (95% Cl: 99.5%-99.9%)
PPV: 17.6% (95% Cl: 9.5%-22.1%)

Predicate Device(s)

BriefCase (K190072, for PE)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

August 26, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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

2

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.

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.

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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3

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

Submitter:

| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel

Phone:+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 software
device
Regulatory Class:Class II
Product Code:QAS (21 C.F.R. 892.2080)
Predicate Device:BriefCase (K190072, for PE)

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

4

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.

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 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.

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

5

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 Device
Aidoc Briefcase for PE triage
(K190072)Subject Device
Aidoc Briefcase for iPE triage
(K201020)
Intended Use /
Indications for UseBriefCase is a radiological
computer aided triage and
notification software indicated for
use in the analysis of CTPA
images. The device is intended
to assist hospital networks and
trained radiologists in workflow
triage by flagging and
communication of suspected
positive findings of Pulmonary
Embolism (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
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 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 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 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.

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 |
| | Predicate Device | Subject Device |
| | Aidoc Briefcase for PE triage
(K190072) | Aidoc Briefcase for iPE triage
(K201020) |
| | | responsible for viewing full images
per the standard of care. |
| User population | Radiologist | Radiologist |
| Anatomical region of
interest | Chest | Chest |
| Inclusion/
Exclusion criteria | Inclusion Criteria

  • CTPA protocols.
  • Single energy exams.
  • Scans performed with 64-
    slice scanner or greater
    number of detectors.
  • Scans performed on
    adults/transitional adults ≥ 18
    years of age.
  • Slice thickness 0.5 - 3.0 mm
    axial.
    Exclusion Criteria
  • All studies that are technically
    inadequate, including studies
    with motion artifacts, severe
    metal artifacts, sub-optimal
    bolus or inadequate field of
    view. | Inclusion criteria
  • Contrast-enhanced chest CTs
    (but not dedicated CTPA
    protocol.
  • Single energy exams.
  • Scans performed with a 64
    slice or greater number of
    detectors.
  • Scans performed on
    adults/transitional adults ≥ 18
    years of age.
  • Slice thickness: 0.5mm -
    2.0mm axial.
    Exclusion Criteria
  • All studies that are technically
    inadequate, including studies
    with motion artifacts, severe
    metal artifacts, or inadequate
    field of view. |
    | Data acquisition
    protocol | CTPA protocol | Contrast-enhanced chest CTs (but
    not dedicated CTPA protocol) |
    | 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 low-quality,
    compressed, grayscale preview
    image that is captioned "Not for
    diagnostic use". | Presentation of a low-quality,
    compressed, grayscale preview
    image that is captioned "Not for
    diagnostic use". |
    | Alteration of original
    image | No | No |
    | Removal of cases from
    worklist queue | No. The device operates in
    parallel with the standard of care,
    which remains the default option
    for all cases. Unflagged cases
    are not de-prioritized. | No. The device operates in
    parallel with the standard of care,
    which remains the default option
    for all cases. Unflagged cases are
    not de-prioritized. |
    | | Predicate Device
    Aidoc Briefcase for PE triage
    (K190072) | Subject Device
    Aidoc Briefcase for iPE triage
    (K201020) |
    | Structure | - AHS module (image
    acquisition).
  • ACS module (image
    processing).
  • Aidoc Worklist application for
    workflow integration (worklist
    and non-diagnostic basic
    Image Viewer). | - AHS module (image
    acquisition).
  • ACS module (image
    processing).
  • Aidoc Worklist application for
    workflow integration (worklist
    and non-diagnostic basic
    Image Viewer). |

Table 1. Kev feature comparison

6

7

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.

8

| Parameter | N | Mean
estimate | Lower
Confidence
Limit | Upper
Confidence
Limit | Median | IQR |
|-------------------------------------------------|----|------------------|------------------------------|------------------------------|--------|--------|
| Time-to-exam-open
in the standard of
care | 63 | 223.3 | 125.8 | 320.7 | 70.4 | 217.65 |
| Time-to-notification
BriefCase 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.