(112 days)
Yes
The intended use section explicitly states that the device uses an "artificial intelligence algorithm" to analyze images.
No
This device is intended to assist in workflow triage by flagging and communicating suspected findings to trained radiologists, and does not provide therapy or treatment.
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 is described as a triage and notification software to assist workflow, not for primary diagnosis.
Yes
The device description explicitly states it is a "radiological computer-assisted triage and notification software device" and details the software components and modules. While it interacts with images and potentially hardware for display, the core medical device functionality is described as software.
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 (CTA scans of the head) that are acquired directly from the patient. It does not process samples taken from the patient's body.
- Intended Use: The intended use clearly states it's for the analysis of head CTA images to assist in workflow triage and notification of suspected findings. It explicitly states it is not intended to be used as a diagnostic device.
- Device Description: The device description details the processing of DICOM images, which are digital representations of medical scans, not biological samples.
Therefore, BriefCase falls under the category of medical imaging software or a computer-aided triage device, not an In Vitro Diagnostic.
No
The letter does not explicitly 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 head CTA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
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. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization. The user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVO) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., LVO). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
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
head CTA images
Anatomical Site
Head
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 to evaluate the software's performance in identifying head CTA images containing Large Vessel Occlusion (LVO) in 383 cases from 3 US-based clinical sites.
Summary of Performance Studies
Pivotal Study Summary: Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying head CTA images containing Large Vessel Occlusion (LVO) in 383 cases from 3 US-based clinical sites.
Primary Endpoint: Sensitivity and specificity exceeded the 80% performance goal. Sensitivity was 88.8% (95% C1: 81.9%, 93.8 %) and specificity was 87.2% (95% CI: 82.5%, 91.1%).
Secondary Endpoint: The positive likelihood ratio (PLR) and negative likelihood ratio (NLR) are 6.9 (95% Cl: 5.0-9.6) and 0.13 (95% Cl: 0.1-0.2), respectively.
Time-to-notification: The BriefCase time-to-notification was measured for all True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase device). The BriefCase mean time-to-notification for LVO was 3.8 min (95% Cl: 3.6-4.0).
Key results: Performance validation data, combined with a comparison of time-to-notification metric with the predicate device establish the achievement by the subject BriefCase of preemptive triage in the range of several minutes.
Key Metrics
Sensitivity: 88.8% (95% C1: 81.9%, 93.8 %)
Specificity: 87.2% (95% CI: 82.5%, 91.1%)
Positive Likelihood Ratio (PLR): 6.9 (95% Cl: 5.0-9.6)
Negative Likelihood Ratio (NLR): 0.13 (95% Cl: 0.1-0.2)
PPV (with varying prevalence): 10% (43.5%), 15% (55.0%), 20% (63.4%), 25% (69.8%), 30% (74.8%), 35% (78.9%), 40% (82.2%), 45% (85.0%), 50% (87.4%)
NPV (with varying prevalence): 10% (98.6%), 15% (97.8%), 20% (96.9%), 25% (95.9%), 30% (94.8%), 35% (93.5%), 40% (92.1%), 45% (90.5%), 50% (88.6%)
Predicate Device(s)
BriefCase (K180647)
Reference Device(s)
ContaCT (DEN170073)
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
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Aidoc Medical, Ltd. % John Smith Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004 December 20, 2019
Re: K192383
Trade/Device Name: BriefCase Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QAS Dated: November 22, 2019 Received: November 22, 2019
Dear John 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
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/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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192383
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
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)
മ Prescription Use (Part 21 CFR 801 Subpart D) Ll Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K192383)
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | December 16, 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) |
| Primary Predicate Device: | BriefCase (K180647, for ICH triage) |
| Secondary Predicate Device: | 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) 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. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization. The user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVO) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., LVO). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for
4
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.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies.
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 LVO triage and primary predicate BriefCase for ICH triage (K180647) are identical in all aspects and differ only with respect to the algorithm on LVO and ICH images, respectively. The addition of a notification filter feature to the software platform design is considered a minor change which does not alter the safety and efficacy profile of the device.
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. Both devices are intended to aid in triage and prioritization of radiological images and utilize the same design of deep learning algorithm trained on medical images. They differ only with regard to the training on image type, specifically, the predicate device processes head CTs and is indicated for intracranial hemorrhage triage, while the subject device processes head CTA images and is indicated for Large Vessel Occlusion (LVO) triage. Both devices are intended to provide radiologists with notifications and unannotated low-quality 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 within the range of several minutes from the time a case comes in for processing as well as 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 (captioned 'not for diagnostic use''), to turn to the local PACS to perform evaluation of the original series earlier than would have been the case without BriefCase.
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Thus, the subject and primary 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.
In addition, it is also important to note that the proposed indications for use are substantially equivalent to a secondary predicate, the ContaCT device (DEN170073), which is cleared for LVO triage. Both devices send triage notifications as well as compressed preview images within the range of several minutes from the time a case comes in for processing. A table comparing the key features of the subject and the predicate devices is provided below.
The ContaCT differs from the subject device regarding the party receiving the notifications. While the ContaCT sends notifications on time-sensitive cases with a critical finding to a neurovascular specialist, the subject device sends them to the radiologist who then contacts a specialist (neurologist, neuro-interventionalist or any other clinician capable of treating stroke patients). Yet, there is clinical benefit in the subject workflow similar to alerting a radiologist of an ICH (or an LVO in this case). Thus, it is relevant to report time-to-notification to alert a radiologist, as well as estimate the time-to-open, based on the alert and worst-case assumption for responding. In addition, the subject device features a notification filter that enables the user to refrain from receiving certain notifications, per pathology or per center.
Lastly, again, all three devices do not remove cases from the standard reading queue and are operating in parallel to the standard of care, which remains the default option for all cases.
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| Table 1. Key feature comparison | |||
|---|---|---|---|
| Subject Device | Primary Predicate Device | Secondary Predicate Device | |
| Aidoc Briefcase for LVO triage | Aidoc Briefcase for ICH triage | Viz.Al ContaCT Software | |
| (K180647) | (DEN170073) | ||
| Intended Use / | |||
| Indications for | |||
| Use | BriefCase is a radiological computer | ||
| aided triage and notification software | |||
| indicated for use in the analysis of | |||
| head CTA images. The device is | |||
| intended to assist hospital networks | |||
| and trained radiologists in workflow | |||
| triage by flagging and | |||
| communication of suspected positive | |||
| findings of Large Vessel Occlusion | |||
| (LVO) pathologies. |
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 | 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 | 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 |
| | triage/prioritization of medical
images. Notified clinicians are
responsible for viewing full images
per the standard of care. | professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of 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 not be used in-lieu of full
patient evaluation or relied upon to
make or confirm diagnosis. | |
| User population | Radiologist | Radiologist | Clinician (e.g., neurovascular
specialist) |
| Anatomical
region of
interest | Head | Head | Head |
| Inclusion/
Exclusion
criteria | Inclusion criteria Head CTA protocol with a 64-
slice scanner or higher; Scans performed on
adults/transitional adults ≥ 18
years of age; Slice thickness 0.5 mm – 1.0 mm. Exclusion Criteria All scans that are technically
inadequate, including motion
artifacts, severe metal artifacts,
sub-optimal bolus timing or an
inadequate field of view. | Inclusion Criteria Head non-enhanced CT (NECT)
with a 64-slice scanner or higher; Scans performed on
adults/transitional adults ≥ 18
years of age; Slice thickness 0.625 mm to 5.1
mm. Exclusion Criteria All scans that are technically
inadequate; including motion
artifacts, severe metal artifacts,
inadequate field of view, etc. | Inclusion Criteria: The patient is older than 22 years
of age when presenting to the
healthcare facility; The images were from patients
who underwent a stroke protocol
assessment; and
Head and neck CTA. Exclusion Criteria:
Series used to identify potential LVOs
were axial thin slice CTAs. CTA series
may have been excluded because of
insufficient technical quality. Exclusion
criteria included: Series containing metal artifacts in
the soft matter of the brain; Series that are non-axial; Series containing missing slices; Series displaying no visible |
| | | | contrast due to bad bolus timing
during the series acquisition
process;
• Series containing inconsistent pixel
spacing;
• Series containing slices thicker
than 0.625mm;
• Series containing improperly
ordered slices (e.g. as a result of
manual correction by an Imaging
technician); and
• Series containing an incomplete skull. |
| View DICOM
data | DICOM Information about the
patient, study and current image | 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. | 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. | Artificial intelligence algorithm. |
| Notification/Prio
ritization | Yes | 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. | Presentation of a small, compressed,
black and white preview image that is
labeled "Not for diagnostic use". |
| Alteration of
original image | No | No | No |
| Removal of
cases from
worklist queue | No | No | No |
| Structure | AHS module (image acquisition); | AHS module (image acquisition); | Image Forwarding Software |
| - ACS module (image processing);
- Aidoc Worklist application for
workflow integration (worklist and
Image Viewer).
Addition of minor changes in the
software platform, e.g. notification
filter, which neither impacts the
order in which notification come in,
nor affects the safety and efficacy
profile of the device. | - ACS module (image processing); - Aidoc Worklist application for
workflow integration (worklist and
Image Viewer). | - Image Processing and Analysis
Software - Non-diagnostic DICOM viewing
mobile application | |
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Performance Data
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying head CTA images containing Large Vessel Occlusion (LVO) in 383 cases from 3 US-based clinical sites.
Primary Endpoint
Sensitivity and specificity exceeded the 80% performance goal. Sensitivity was 88.8% (95% C1: 81.9%, 93.8 %) and specificity was 87.2% (95% CI: 82.5%, 91.1%).
Secondary Endpoint
The positive likelihood ratio (PLR) and negative likelihood ratio (NLR) are 6.9 (95% Cl: 5.0-9.6) and 0.13 (95% Cl: 0.1-0.2), respectively. The table below presents the positive value (PPV) and negative predictive value (NPV) with varying prevalence:
| Prevalence | PPV | NPV |
|---|---|---|
| 10% | 43.5% | 98.6% |
| 15% | 55.0% | 97.8% |
| 20% | 63.4% | 96.9% |
| 25% | 69.8% | 95.9% |
| 30% | 74.8% | 94.8% |
| 35% | 78.9% | 93.5% |
| 40% | 82.2% | 92.1% |
| 45% | 85.0% | 90.5% |
| 50% | 87.4% | 88.6% |
In addition, the time-to-notification metric observed for the BriefCase software in the three medical centers was compared to the equivalent metric of the predicate devices.
- 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 BriefCase time-to-notification was measured for all True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase device) and is given in Table 2 below. The Table also displays the same metric reported for the BriefCase ICH.
The time-to-notification results obtained for the subject BriefCase device show comparability with the primary predicate with regard to time savings to the standard of care review. The BriefCase mean time-to-notification for LVO was 3.8 min (95% Cl: 3.6-4.0). The time-to-notification for the BriefCase for ICH triage was 4.46 minutes (95% CL: 4.10-4.83).
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| Parameter | N | Mean
estimate | Lower
Confidence
Limit | Upper
Confidence
Limit |
|------------------------------------------|-----|------------------|------------------------------|------------------------------|
| Time-to-notification
of BriefCase LVO | 111 | 3.8 | 3.6 | 4.0 |
| Time-to-notification
of BriefCase ICH | 59 | 4.46 | 4.10 | 4.83 |
Table 2. Time-to- notification comparison for BriefCase devices
Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase for LVO triage the radiologists may have the same benefit in time saving as with the BriefCase for ICH triage.
In summary, performance validation data, combined with a comparison of time-to-notification metric with the predicate device establish the achievement by the subject BriefCase of preemptive triage in the range of several minutes.
Conclusions
The subject BriefCase for LVO triage, the primary predicate BriefCase for ICH triage and the secondary predicate ContaCT for LVO triage are all intended to aid in prioritization and triage of radiological images for the indications of Large Vessel Occlusion and Intracranial Hemorrhage respectively. The labeling of both the subject and the predicate devices clearly states that the devices are not for diagnostic use. Both devices are software packages with similar technological characteristics and principles of operation (with minor changes in the software platform of the subject device, such as a notification filter), both incorporating AI algorithms that process images, and software to send notifications and display unannotated compressed low-quality preview images. In all three devices, the labeling instructs the user to further evaluate and diagnose based only on the original images in the local PACS.
All three 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. The subject and the primary predicate achieve performance of time-to-notification metric in the range of several minutes, and thus contribute similarly to triage and early involvement of the radiologist in evaluating suspected images of LVO and ICH respectively.
The BriefCase device for LVO triage is thus substantially equivalent to the primary predicate BriefCase for ICH triage on time-to-notification metric.