(142 days)
Not Found
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "uses an artificial intelligence algorithm to analyze images".
No
This device is a software for workflow triage and notification, assisting radiologists in prioritizing cases. It does not provide treatment or directly affect the patient's condition.
No.
The "Intended Use / Indications for Use" section explicitly states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device." Additionally, the "Device Description" mentions that compressed preview images are "not for diagnostic use" and "not intended for primary diagnosis beyond notification."
Yes
The device description explicitly states it is a "radiological computer-assisted triage and notification software device" and details the software components and modules without mentioning any proprietary hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "radiological computer aided triage and notification software" and is "intended to assist hospital networks and trained radiologists in workflow triage". It explicitly states that it is "not intended to be used as a diagnostic device."
- Device Description: The description reinforces its role in "preemptive triage and prioritization" and that the compressed preview images are "not for diagnostic use" and "not intended for primary diagnosis beyond notification."
- Function: The device analyzes images to flag potential findings and provides notifications to facilitate earlier review by a trained professional. It does not perform tests on biological samples or provide a definitive diagnosis.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates on medical images and assists in workflow, not in the analysis of biological samples.
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. The relevant section "Control Plan Authorized (PCCP) and relevant text" states "Not Found".
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 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.
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); (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 and filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.
The Worklist Application displays the pop-up notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name and accession number. A list of all incoming cases with suspected findings is also displayed. In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis bevond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to assess the available images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
non-enhanced head CT images, CT scan of the head or neck
Anatomical Site
Head
Indicated Patient Age Range
Not Found
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, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing intracranial hemorrhage (ICH) findings in 198 cases from 3 clinical sites (2 US and 1 OUS). There were approximately an equal number of positive and negative cases (images with ICH versus without ICH) included in the analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software.
Sample size: 198 cases from 3 clinical sites (2 US and 1 OUS) for sensitivity and specificity evaluation. 59 true positive ICH cases from 2 medical centers (1 US, 1 OUS) for time-to-notification comparison.
Sensitivity was observed to be 93.6% (95% Cl: 86.6%-97.6%) and specificity was observed to be 92.3% (95% Cl: 85.4%-96.6%).
mean time-to-exam-open: 72.58 minutes (95% Cl 45.02-100.14)
mean time-to-notification: 4.46 minutes (95% Cl 4.10-4.83)
mean difference of 68.11 minutes (95% Cl 40.50-95.72) for these two metrics is statistically significant (P-value
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
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August 1st, 2018
Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Regulatory Counsel/Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K180647
Trade/Device Name: BriefCase Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: II Product Code: QAS Dated: July 5, 2018 Received: July 5, 2018
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Jeff Rodgers
Digitally signed by Jeffrey J.
Ballyns -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=200
9569725, cn=Jeffrey J. Ballyns -S
Date: 2018.08.01 09:12:29
04'00'
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K180647
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 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 findinas. 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 triace/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) | |
|---|---|
[X] Prescription Use (Part 21 CFR 801 Subpart D)
| Prescription Use (Part 21 CFR 801 Subpart D)
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3
510(k) Summary
Aidoc Medical, Ltd.'s BriefCase (K180647)
Submitter:
| Aidoc Medical, Ltd.
Yigal Alon 92
| Tel-Aviv, Israel | |
|---|---|
| Phone: | +1 315-207-3494 |
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | July 31, 2018 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer aided triage and notification software |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | Viz.Al's ContaCT (DEN170073) |
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 and filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.
The Worklist Application displays the pop-up notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name and accession number. A list of all incoming cases with suspected findings is also displayed. In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis bevond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to assess the available images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
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 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 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.
Comparison of Technological Characteristics
The subject and predicate devices are radiological computer-assisted triage and notification software programs. Both devices are artificial intelligence algorithms incorporated software packages for use with CT scanners, PACS, and workstations. Both devices process images intended to aid in prioritization and triage of radiological medical images. The predicate device processes brain CT angiogram images and is indicated for the detection of large vessel occlusion, while the subject device processes head CT images and is indicated for Intracranial Hemorrhage. While the subject device's indications for use differ slightly from the predicate device, both devices are intended to provide notifications and preview head images of potential findings to radiologists and other clinicians for the purpose of treatment planning and follow up.
Both software devices notify a designated list of clinicians (the predicate device - a neurovascular specialist, the subject device - a radiologist) of the availability of time sensitive radiological medical images for review based on computer aided image analysis performed by the device's Al algorithm. The subject device sends notifications and compressed previews to the workstations' desktop of the radiologist. Those notifications work in the standard of care. Thev prompt the radiologist to start preemptive triage of a flagged case, upon which he may decide after observing the preview on his desktop, to turn to the local PACS to perform the evaluation. If a notification is rejected, the case still remains in the queue to be handled per the standard of care.
The predicate device also sends notifications and compressed previews, but to the mobile phone of a neuro-specialist independent of the standard of care, thus both devices work in parallel to the standard of care. Both compressed previews are for informational purposes only and not for diagnostic use, and in both cases, the notified clinicians are responsible for using the local imaging system for viewing the original images and engage the referring clinician for diagnosis and treatment decision.
The predicate and subject devices process CT images using similar techniques and a similar artificial intelligence algorithm. Specifically, the subject and predicate software utilize a deep learning algorithm trained on medical images. The deep-learning process allows for high accuracy in the detection of initial suspect locations. As a system, the BriefCase raises the same types of safety and effectiveness questions as the predicate; namely, accurate detection of
5
findings within the reviewed and processed study on which a physician can base a clinically useful triage/prioritization assessment considering all available clinical information.
lt is important to note that, like the predicate, the device does not remove cases from a reading queue. Again, both devices operate in parallel with the standard of care, which remains the default option for all cases.
| | Aidoc Briefcase Software | Viz.AI ContaCT Software
(DEN170073) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
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. | ContaCT is a notification-only,
parallel workflow tool for use by
hospital networks and
trained clinicians to identify and
communicate images of specific
patients to a specialist, independent
of standard of care workflow.
ContaCT uses an artificial
intelligence algorithm to analyze
images for findings
suggestive of a pre-specified clinical
condition and to notify an
appropriate medical specialist of
these findings in parallel to standard
of care image interpretation.
Identification of suspected findings
is not for diagnostic use beyond
notification.
Specifically, the device analyzes CT
angiogram images of the brain
acquired in the acute setting, and
sends notifications to a
neurovascular specialist that a
suspected large vessel occlusion
has been identified and
recommends review of those
images. Images can be previewed
through a mobile application.
Images that are previewed through
the mobile application are
compressed and are for
informational purposes only and not
intended for diagnostic use beyond
notification.
Notified clinicians are responsible
for viewing non-compressed images
on a diagnostic viewer and
engaging in appropriate patient
evaluation and relevant discussion
with a treating physician before
making care-related decisions or
requests. ContaCT is limited to
analysis of imaging data and should |
| | | |
| User population | Radiologist | not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Clinician (e.g. neurovascular specialist) |
| Anatomical
region of interest | Head | Head |
| Data acquisition
protocol | Non contrast CT scan of the head or neck | CT angiogram images of the brain |
| 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, highlight, or direct users' attention to a specific location in the original image | No; device does not mark, highlight, 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 preview of the study for initial assessment not meant for diagnostic purposes
The device operates in parallel with the standard of care, which remains the default option for all cases | Presentation of notification and preview of the study for initial assessment not meant for diagnostic purposes
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 |
A table comparing the key features of the subject and predicate devices is provided below.
6
Performance Data
Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing intracranial hemorrhage (ICH) findings in 198 cases from 3 clinical sites (2 US and 1 OUS). There were approximately an equal number of positive and negative cases (images with ICH versus without ICH) included in the analysis.
Sensitivity and specificity exceeded the 80% performance qoal. Specifically, sensitivity was observed to be 93.6% (95% Cl: 86.6%-97.6%) and specificity was observed to be 92.3% (95% Cl: 85.4%-96.6%).
In addition, a secondary endpoint measure was Briefcase's potential clinical benefit of worklist prioritization for true positive ICH cases. For that purpose, in two medical centers, one in Israel and one in the US, Aidoc compared the key standard-of-care metric of time-to-exam-open to the software's time-to-notification metric.
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.
7
BriefCase time-to-notification has been documented for all 198 cases. Fifty-nine (59) cases have been identified as true positive (i.e., identified as positive by both the BriefCase and the ground truth) and the time-to-exam-open has been also collected for these cases.
As shown in the table below, analysis demonstrated that standard of care time-to-exam-open (72.6 minutes: 95% Cl 45.0-100.2) is significantly longer than the parallel time-to-notification of the BriefCase software (4.5 minutes: 95% Cl 4.1-4.8). The mean difference of 68.1 minutes (95% Cl 40.5-95.7) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive ICH case and acts on it immediately, it can on average save 68.1 (95% Cl 40.5-95.7) minutes compared to the time-to-exam-open in a FIFO reading queue. The value of 68.1 is based on the study of 59 cases, taken from 2 medical centers (1 US, 1 OUS), and may vary in practice.
| Parameter | Mean estimate | Lower
Confidence
Limit | Upper
Confidence
Limit | Median | P-value |
|----------------------------------------------|---------------|------------------------------|------------------------------|--------|---------|
| Time-to-open-exam in
the standard of care | 72.58 | 45.02 | 100.14 | 41.00 | |
| Time-to-notification of
BriefCase | 4.46 | 4.10 | 4.83 | 3.95 | |
| Difference | 68.11 | 40.50 | 95.72 | 37.42 |