(90 days)
Not Found
Yes
The document explicitly states multiple times that the device uses an "artificial intelligence algorithm" to analyze images.
No
Explanation: This device is intended to assist in workflow triage and notification, not to provide therapy or directly treat a disease.
No
The document explicitly states multiple times that "The device does not alter the original medical image and is not intended to be used as a diagnostic device" and "not for diagnostic use beyond notification".
Yes
The device is explicitly described as a "radiological computer-assisted triage and notification software device" and its components are listed as software modules and off-the-shelf operating systems. There is no mention of proprietary hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BriefCase's Function: BriefCase analyzes medical images (CT scans) that are acquired directly from the patient's body. It does not process biological samples.
- Intended Use: The intended use is to assist in workflow triage and notification based on image analysis, not to perform a diagnostic test on a biological sample.
- Device Description: The device description details software components and image processing, not laboratory equipment or reagents used for analyzing biological samples.
Therefore, BriefCase falls under the category of medical imaging software or a medical device that processes medical images, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (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 non-enhanced head CT and 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 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 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
OAS
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 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. 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 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.
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
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.
Mentions AI, DNN, or ML
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.
Both devices are artificial intelligence algorithms incorporated software packages for use with CT scanners, PACS, and radiology workstations.
Artificial intelligence algorithm with database of images
Input Imaging Modality
non-enhanced head CT and CTPA images
Anatomical Site
Head and chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained radiologists in workflow triage
assist hospital networks
Radiologist
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
Pilot Study Summary
The company conducted a retrospective evaluation of 2,803 CT pulmonary angiogram (CTPA) exams of patients with suspected PE, from a single center. The goal of this study was primarily to demonstrate that the BriefCase software can identify PE with high accuracy. Ground truth was determined by a review of a single radiologist and the radiology report. Another radiologist was used to break ties between the report and the reviewer.
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying CTPAs containing pulmonary embolism in 184 cases from 3 clinical sites (2 US and 1 OUS). There were approximately an equal number of positive and negative cases (images with PE versus without PE) included in the analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pilot Study Summary
The company conducted a retrospective evaluation of 2,803 CT pulmonary angiogram (CTPA) exams of patients with suspected PE, from a single center. The goal of this study was primarily to demonstrate that the BriefCase software can identify PE with high accuracy. Ground truth was determined by a review of a single radiologist and the radiology report. Another radiologist was used to break ties between the report and the reviewer.
Performance Endpoints: Specificity and sensitivity.
Pilot Study Results
Sensitivity was 93.0% (95% Cl: 90.2%-95.1%). Specificity was 93.7% (95% Cl: 92.7%-94.6%).
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying CTPAs containing pulmonary embolism in 184 cases from 3 clinical sites (2 US and 1 OUS). There were approximately an equal number of positive and negative cases (images with PE versus without PE) included in the analysis.
Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be 90.6% (95% C1: 82.2%-95.9%) and specificity was observed to be 89.9% (95% C1: 82.2%-95.1%).
In addition, a secondary endpoint measure was Briefcase's potential clinical benefit of worklist prioritization for true positive PE cases. For that purpose, in two medical centers, one in Israel and one in the US, Aidoc compared the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for PE cases.
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 back to the worklist application. The standard of care time-to-open-exam consisted of the time from the initial scan of the patient to when the radiologist first opened the exam for review.
The standard of care time-to-exam-open was compared to the BriefCase time-to-notification for 51 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 PE was 3.9 minutes (95% Cl: 3.7-4.1). In contrast, standard of care time-to-exam-open was much longer (64.1 minutes: 95% Cl 36.6-91.5). The mean difference of 60.2 minutes (95% Cl 32.7-87.6) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive PE case and acts on it immediately, it can on average save 60.2 minutes (95% C1 32.7-87.6) compared to the time-toexam-open in a FIFO reading queue. The value of 60.2 is based on the study of 51 cases, taken from 2 medical centers (1 US, 1 OUS), and may vary in practice.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pilot Study Results
Sensitivity was 93.0% (95% Cl: 90.2%-95.1%). Specificity was 93.7% (95% Cl: 92.7%-94.6%).
Specifically, sensitivity was observed to be 90.6% (95% C1: 82.2%-95.9%) and specificity was observed to be 89.9% (95% C1: 82.2%-95.1%).
Predicate Device(s)
BriefCase (K180647, for ICH triage)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
ยง 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "U.S. Food & Drug Administration".
Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004 April 15, 2019
Re: K190072
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: OAS Dated: January 15, 2019 Received: January 15, 2019
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/cfpmr/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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
__ Over-The-Counter Use (21 CFR
510(k) Number (if known) K190072
Device Name
BriefCase
Indications for Use (Describe)
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 trained radiologists 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 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) | |
|---|---|
| ------------------------------------------------- | -- |
& Prescription Use (Part 21 CFR 801 Subpart D) 801 Subpart C)
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3
510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K190072)
Submitter:
| | Aidoc Medical, Ltd.
92 Yigal Alon St.
Tel-Aviv, Israel
Phone: | +972-73-7946870 |
|--|------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Contact Person: | N. Epstein, Ph.D. |
| | Date Prepared: | April 4th, 2019 |
| | Name of Device: | BriefCase |
| | 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 (K180647, for ICH triage) |
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 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. 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 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.
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.
4
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 trained radiologists 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.
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.
Comparison of Technological Characteristics
The subject BriefCase for PE triage and predicate device BriefCase for ICH triage (K180647) are identical in all aspects and defer only with respect to the training of the algorithm on PE and ICH 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 CT scanners, PACS, and radiology workstations. As noted above, both devices are intended to aid in triage and prioritization of radiological images. The predicate device processes head CTs and is indicated for intracranial hemorrhage triage, while the subject device also processes CTPA images and is indicated for Pulmonary Embolism triage. Both devices are intended to provide radiologists with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage.
In addition, both software devices notify the attending radiologist of the availability of time sensitive radiological medical images for review based on computer aided image analysis. Both devices send notifications and compressed previews to the radiology workstations' desktop. Notifications 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 without BriefCase.
Thus, the subject and predicate BriefCase raise the same types of safety and effectiveness 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. 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.
5
| Table 1. Key feature comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Aidoc Briefcase for ICH triage (K180647) | Aidoc Briefcase for ICH and PE triage | |
| 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 trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (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 eyond 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 trained radiologists 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 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 | Radiologist |
| Anatomical
region of
interest | Head | Head and chest |
| Data
acquisition
protocol | Non-contrast head CT scan | 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. |
| Alteration of
original image | No | No |
| Removal of
cases from
worklist queue | No | No |
6
Performance Data
Pilot Study Summary
The company conducted a retrospective evaluation of 2,803 CT pulmonary angiogram (CTPA) exams of patients with suspected PE, from a single center. The goal of this study was primarily to demonstrate that the BriefCase software can identify PE with high accuracy. Ground truth was determined by a review of a single radiologist and the radiology report. Another radiologist was used to break ties between the report and the reviewer.
Performance Endpoints: Specificity and sensitivity.
Pilot Study Results
Sensitivity was 93.0% (95% Cl: 90.2%-95.1%). Specificity was 93.7% (95% Cl: 92.7%-94.6%).
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying CTPAs containing pulmonary embolism in 184 cases from 3 clinical sites (2 US and 1 OUS). There were approximately an equal number of positive and negative cases (images with PE versus without PE) included in the analysis.
Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be 90.6% (95% C1: 82.2%-95.9%) and specificity was observed to be 89.9% (95% C1: 82.2%-95.1%).
In addition, a secondary endpoint measure was Briefcase's potential clinical benefit of worklist prioritization for true positive PE cases. For that purpose, in two medical centers, one in Israel and one in the US, Aidoc compared the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for PE cases.
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 back to the worklist application. The standard of care time-to-open-exam consisted of the time from the initial scan of the patient to when the radiologist first opened the exam for review.
The standard of care time-to-exam-open was compared to the BriefCase time-to-notification for 51 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 PE was 3.9 minutes (95% Cl: 3.7-4.1). In contrast, standard
7
of care time-to-exam-open was much longer (64.1 minutes: 95% Cl 36.6-91.5). The mean difference of 60.2 minutes (95% Cl 32.7-87.6) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive PE case and acts on it immediately, it can on average save 60.2 minutes (95% C1 32.7-87.6) compared to the time-toexam-open in a FIFO reading queue. The value of 60.2 is based on the study of 51 cases, taken from 2 medical centers (1 US, 1 OUS), and may vary in practice.
| Parameter | N | Mean
estimate | Lower
Confidence
Limit | Upper
Confidence
Limit | Median | P-value |
|----------------------------------------------|----|------------------|------------------------------|------------------------------|--------|---------|
| Time-to-open-exam in
the standard of care | 51 | 64.1 | 36.6 | 91.5 | 49.0 | |
| Time-to-notification of
BriefCase PE | 51 | 3.9 | 3.7 | 4.1 | 3.9 | |
| Difference | 51 | 60.2 | 32.7 | 87.6 | 45.2 |