(28 days)
Yes
The document explicitly states that the device uses an "artificial intelligence algorithm" and "deep learning Al algorithms" to analyze images.
No
The device is described as radiological computer aided triage and notification software intended to assist with workflow triage by flagging and communicating suspected findings. It is not intended for diagnostic use or to alter medical images, nor does it directly treat or mitigate a disease or condition.
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." and "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."
Yes
The device description explicitly states that BriefCase is a "radiological computer-assisted triage and notification software device" and details its software components and modules. There is no mention of accompanying hardware that is part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that BriefCase is a "radiological computer aided triage and notification software indicated for use in the analysis of CTPA images". It is intended to "assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings". It explicitly states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device."
- Nature of the Device: The device processes medical images (CTPA) and provides notifications for suspected findings to aid in workflow prioritization. It does not analyze biological samples (blood, urine, tissue, etc.), which is a key characteristic of IVDs.
- Diagnostic vs. Triage: The device is designed for triage and notification, not for providing a definitive diagnosis. The user is responsible for viewing the full images and making the diagnosis based on their professional judgment and other patient information.
IVDs are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. BriefCase operates on medical images, not biological specimens, and its purpose is to assist in workflow, not to provide a diagnostic result itself.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Pulmonary Embolism (PE) 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 PE 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 consists 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/Orchestrator) for image acquisition: (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Desktop Application for workflow integration.
DICOM images are received, saved, filtered and de-identified before processing. Filtration matches metadata fields with keywords. Series are processed chronologically by running the algorithms on each series to detect suspected cases. The software then flags suspect cases by sending notifications to the desktop application, thereby facilitating triage and prioritization by the user. As the BriefCase software platform incorporates several triage algorithms, the user may opt to filter out notifications by pathology, e.g., a chest radiologist may choose to filter out alerts on ICH cases, and a neuro-radiologist would opt to divert pulmonary embolism ("PE") alerts. 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 alerts by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc Desktop Application.
The desktop application feed displays all incoming suspect cases, each notified case in a line. Hovering over a line in the feed pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
Presenting the users with worklist prioritization 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
Mentions artificial intelligence algorithm, deep-learning algorithms, Al algorithms.
Input Imaging Modality
CTPA images
Anatomical Site
Chest
Indicated Patient Age Range
Adults or transitional adolescents aged 18 and older.
Intended User / Care Setting
Hospital networks and appropriately trained medical specialists.
Description of the training set, sample size, data source, and annotation protocol
Not Found. The document states: "The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm."
Description of the test set, sample size, data source, and annotation protocol
A retrospective, blinded, multicenter, study was conducted with the BriefCase software to evaluate the software's performance in identifying CTPA images containing Pulmonary Embolism (PE) in 499 cases from 6 US-based clinical sites, compared to the ground truth as determined by three senior board-certified radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective, blinded, multicenter study.
Sample Size: 499 cases.
Key Results: Primary endpoints were sensitivity and specificity with an 80% performance goal. Sensitivity was 94.86% (95% Cl: 90.99%, 97.41%) and specificity was 94.04% (95% Cl: 90.62%, 96.49%). Both exceeded the 80% performance goal. Secondary endpoints included BriefCase time-to-notification compared to the predicate device. The BriefCase mean time-to-notification for BriefCase for PE triage was 78.0 seconds (95% CI: 73.6-82.3), compared to 234 seconds (95% CI: 222-246) for the predicate PE triage. NPV was 99.0% (95% Cl: 98.3%- 99.5%) and PPV was 73.7% (95% Cl: 63.9%- 81.7%). PLR was 15.903 (95% Cl: 10.019 - 25.242) and NLR was 0.055 (95% Cl: 0.031- 0.097).
Additional Operating Points:
AOP1: Sensitivity was 98.60% (95% C1: 95.96%-99.71%) and specificity was 85.26% (95% C1: 80.61%-89.17%).
AOP2: Sensitivity was 86.45% (95% C1: 81.12%-90.73%) and specificity was 98.25% (95% C1: 95.95%-99.43%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 94.86% (95% C1: 90.99%, 97.41%)
Specificity: 94.04% (95% Cl: 90.62%, 96.49%)
NPV: 99.0% (95% C1: 98.3%- 99.5%)
PPV: 73.7% (95% C1: 63.9%- 81.7%)
PLR: 15.903 (95% Cl: 10.019 - 25.242)
NLR: 0.055 (95% Cl: 0.031- 0.097)
Predicate Device(s)
BriefCase (PE triage, K203508)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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August 26, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON DC 20004
Re: K222277
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: July 29, 2022 Received: July 29, 2022
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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)
K222277
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Pulmonary Embolism (PE) 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 PE findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
| Type of Use (Select one or both, as applicable) |
|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for "Amdocs". The logo is written in a sans-serif font, with the letters in blue. There is a small orange circle to the right of the letter "c".
510(k) Summary Aidoc Medical, Ltd.'s BriefCase K222277
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
| Tel-Aviv, Israel | |
|---|---|
| Phone: | +972-73-7946870 |
| Contact Person: | Amalia Schreier, LLM. |
| Date Prepared: | July 29, 2022 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Requlatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (PE triage, K203508) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and consists 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/Orchestrator) for image acquisition: (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Desktop Application for workflow integration.
DICOM images are received, saved, filtered and de-identified before processing. Filtration matches metadata fields with keywords. Series are processed chronologically by running the algorithms on each series to detect suspected cases. The software then flags suspect cases by sending notifications to the desktop application, thereby facilitating triage and prioritization by the user. As the BriefCase software platform incorporates several triage algorithms, the user may opt to filter out notifications by pathology, e.g., a chest radiologist may choose to filter out alerts on ICH cases, and a neuro-radiologist would opt to divert pulmonary embolism ("PE") alerts. 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 alerts by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc Desktop Application.
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The desktop application feed displays all incoming suspect cases, each notified case in a line. Hovering over a line in the feed pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
Presenting the users with worklist prioritization 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 CTPA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Pulmonary Embolism (PE) 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 notification for cases with suspected PE 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 BriefCase for PE triage (K203508) are identical in most aspects and differ with respect to their algorithm performance due to training the subject device on a larger data set, the addition of 2 operating points, and ability to process single and dual energy exams.
Both the predicate and subject device are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence, deep-learning algorithms that incorporate software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations.
Both devices are intended to aid in triage and prioritization of radiological images and utilize the same design of deep learning algorithms trained on medical images. Both devices are intended to provide specialists with notifications and unannotated low-quality preview images of suspect studies for the purpose of preemptive triage.
The subject and predicate BriefCase devices raise the same types of safety and effectiveness
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questions, namely, accurate detection of findings within the processed study. It is important to note that, like the predicate, the subject device neither removes cases from the standard of care reading queue nor deprioritizes cases. 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 the primary predicate devices is provided below.
| | Predicate Device
Aidoc Briefcase (K203508) | Subject Device
Aidoc Briefcase (K222277) |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Pulmonary Embolism (PE) 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. | 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 PE 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 |
| | Predicate Device
Aidoc Briefcase (K203508) | Subject Device
Aidoc Briefcase (K222277) |
| | 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. | 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 | Hospital networks and
appropriately trained medical
specialists | Hospital networks and
appropriately trained medical
specialists |
| Anatomical Region of Interest | Chest | Chest |
| Data Acquisition Protocol | CTPA | CTPA |
| Notification-Only (/notification
alerts), Parallel Workflow Tool | Yes | Yes |
| Images
Format | DICOM | DICOM |
| Interference
with
Standard
Workflow | No. No cases are removed
from Worklist or deprioritized. | No. No cases are removed
from desktop application or
deprioritized. |
| Inclusion/
Exclusion Criteria for Clinical
Performance Testing | Inclusion criteria
- CT pulmonary angiogram
(CTPA) with a 64-slice
scanner or higher; - Slice thickness 0.5 mm -
3.0 mm. - Scans performed on adults/
transitional adults ≥ 18
years of age.
Exclusion Criteria
- All studies that are
technically inadequate,
including studies with
motion artifacts, severe
metal artifacts, sub-optimal
bolus timing or an
inadequate field of view. | Inclusion criteria - CT pulmonary angiogram
(CTPA) with a 64-slice
scanner or higher; - Slice thickness 0.5 mm -
3.0 mm. - Scans performed on adults/
transitional adults ≥ 18
years of age.
Exclusion Criteria
- All studies that are
technically inadequate,
including studies with
motion artifacts, severe
metal artifacts, sub-optimal
bolus timing or an
inadequate field of view. |
| | Predicate Device
Aidoc Briefcase (K203508) | Subject Device
Aidoc Briefcase (K222277) |
| Algorithm | Artificial intelligence algorithm
with database of images. | Artificial intelligence algorithm
with database of images. |
| Structure | - AHS module (image acquisition); - ACS module (image processing);
- Aidoc Worklist application for workflow integration
(worklist and non-diagnostic Image Viewer). | - AHS module (image acquisition); - ACS module (image processing);
- Aidoc Desktop Application for workflow integration
(Feed/Worklist (alternate names) and non-diagnostic Image Viewer) |
Table 1. Key Feature Comparison
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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 CTPA images containing Pulmonary Embolism (PE) in 499 cases from 6 US-based clinical sites, compared to the ground truth as determined by three senior board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm.
Primary endpoints were sensitivity and specificity with an 80% performance goal.
Secondary endpoints were BriefCase time-to-notification compared to the predicate device. Positive Predictive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), and Negative Likelihood Ratio (NLR) were also assessed.
Primary Endpoint
Sensitivity and specificity exceeded the 80% performance goal. Sensitivity was 94.86% (95% C1: 90.99%, 97.41%) and specificity was 94.04% (95% Cl: 90.62%, 96.49%).
Secondary Endpoint
In addition, the time-to-notification metric observed for the BriefCase software in the 6 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 desktop 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 predicate BriefCase PE.
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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 BriefCase for PE triage was 78.0 seconds (95% CI: 73.6-82.3). The time-tonotification for the predicate PE triage was 234 seconds (95% CI: 222-246).
| Time -to-notification
(in seconds) | Mean
Estimate | 95% Lower
CL | 95% Upper
CL | Median | IQR |
|---------------------------------------|------------------|-----------------|-----------------|--------|------|
| Predicate K203508
Processing Time | 234 | 222 | 246 | 234 | N/A |
| BriefCase Time-to-
notification | 78 | 73.6 | 82.3 | 64.5 | 53.2 |
Table 2. Time-to-notification Comparison for BriefCase Devices
NPV was 99.0% (95% C1: 98.3%- 99.5%) and PPV was 73.7% (95% C1: 63.9%- 81.7%).
PLR was 15.903 (95% Cl: 10.019 - 25.242) and NLR was 0.055 (95% Cl: 0.031- 0.097).
Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase for PE triage the clinician may have the same benefit in time saving as with the predicate BriefCase for PE triage.
As can be seen in Table 3 the mean age of patients whose scans were reviewed in the study was 62.1 years, with standard deviation of 17.3 years. Gender distribution was 48% male, 51% female and 1% unknown (Table 4). Scanner distribution can also be found in Table 5 below.
| Table 3. Descriptive Statistics for Age | ||
|---|---|---|
| -- | ----------------------------------------- | -- |
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age | ||||||
| (Years) | 62.1 | 17.3 | 18 | 64 | 90 | 499 |
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| Ground | Gender | All | ||||
|---|---|---|---|---|---|---|
| Truth | Male | Female | ||||
| Results | N | % | N | % | N | % |
| Positive | 113 | 22.6 | 100 | 20.0 | 213 | 42.7 |
| Negative | 127 | 25.5 | 154 | 30.9 | 281 | 56.6 |
| All | 240 | 48.1 | 254 | 50.9 | 494 | 99.0 |
Table 4. Frequency Distribution of Gender
5 cases (4 negative, 1 positive) did not contain any gender information in the DICOM header and were classified as gender unknown.
Table 5. Frequency Distribution of manufacturer
| Manufacturer | N | % |
|---|---|---|
| Siemens | 201 | 40.3% |
| GE | 100 | 20.0% |
| Canon | 99 | 19.8% |
| Philips | 99 | 19.8% |
| Total | 499 | 100% |
Clinical subgroups and confounders present in the dataset included the following: Fully negative; Heart & vascular; Chronic lung diseases; Trauma; Inflammatory; Oncology; None of the above.
Additional operating points:
In addition to the default operating point that was selected to maximize both sensitivity and specificity, two additional operating points (AOP) were selected to maximize specificity while maintaining a lower bound 95% confidence interval of 80% for sensitivity and spectively:
AOP1: Sensitivity was 98.60% (95% C1: 95.96%-99.71%) and specificity was 85.26% (95% C1: 80.61%-89.17%).
AOP2: Sensitivity was 86.45% (95% C1: 81.12%-90.73%) and specificity was 98.25% (95% C1: 95.95%-99.43%).
In summary, performance goals were achieved for the default and two additional operating points.
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Combined with the comparison results of time-to-notification metric with the predicate device, these data establish the achievement by the subject BriefCase of preemptive triage in the range of several minutes.
Conclusions
The subject BriefCase for PE triage and the predicate BriefCase for PE triage are intended to aid in prioritization and triage of radiological images for the indications for suspected positive findings of Pulmonary Embolism (PE) pathologies. Both devices are software packages with the same technological characteristics and principles of operation, incorporating deep learning Al algorithms that process images, and software to send notifications and display unannotated compressed low-quality preview images. In both devices, the labeling clearly states that the devices are not for diagnostic use and instructs the user to further evaluate and diagnose based only on the original images in the local PACS.
Both devices operate in parallel to the standard of care workflow in the sense that they do not change the original image, do not provide any marking on the output preview, do not remove images from the standard of care FIFO queue and do not de-prioritize cases, thus not disturbing standard interpretation of the images. Both devices notify the radiologist of time-sensitive critical cases within the range of several minutes, and thus contribute similarly to the standard of care workflow turnaround time reduction through preemptive triage.
The subject BriefCase device for PE triage is thus substantially equivalent to the primary predicate BriefCase for PE.