(29 days)
BriefCase (RibFx triage, K202992)
Not Found
Yes
The document explicitly states that the device uses an "artificial intelligence algorithm" and mentions "AI processing".
No.
The device is described as radiological computer aided triage and notification software intended to assist in workflow triage by flagging and communicating suspect cases. It is not intended for diagnostic use or to provide therapy.
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" confirms that preview images are "not for diagnostic use, for prioritization only."
Yes
The device description explicitly states that BriefCase is a "radiological computer-assisted triage and notification software" and is "intended to run on a linux-based server in a cloud environment." It processes images and provides notifications through software components, without mentioning any dedicated hardware included as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BriefCase's Function: BriefCase analyzes medical images (Chest CTs) directly, not samples taken from the body. Its purpose is to assist in the workflow triage of these images based on detected findings within the images themselves.
- Intended Use: The intended use clearly states it's for the analysis of chest CT images and to assist in workflow triage by flagging and communicating suspect cases. It explicitly states it is not intended to be used as a diagnostic device.
Therefore, BriefCase falls under the category of medical imaging software or a computer-aided triage device, not an In Vitro Diagnostic.
No
The clearance 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 chest CTs (with or without contrast) 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 communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx 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 (comma separated list FDA assigned to the subject device)
QFM
Device Description
BriefCase is a radiological computer-assisted triage and notification software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase receives filtered DICOM Images, and processes them chronologically by running the algorithms on each series to detect suspected cases. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (desktop application). When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, lowguality, grayscale image that is captioned "not for diagnostic use, for prioritization only" which is displayed as a preview function. This 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 efficient triaqe 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 AI:
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation.
Mentions deep-learning:
Both devices are artificial intelligence, deep-learning algorithms incorporated in software packages for use with DICOM compliant CT scanners, PACS, and radiology workstations.
Input Imaging Modality
chest CTs (with or without contrast)
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 only mentions that "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
Description of the test set: Retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying Chest CTs (with or without contrast) images containing three or more acute Rib fractures (RibFx).
Sample size: 308 cases
Data source: 5 US-based clinical sites.
Annotation protocol: The ground truth was determined by three senior board-certified radiologists, using majority voting.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Retrospective, blinded, multicenter, study.
Sample size: 308 cases.
AUC: 0.98 (95% CI: 0.966, 0.994)
MRMC: Not Found
Standalone performance:
Sensitivity was 98.08% (95% CI: 93.23%, 99.77%)
Specificity was 93.14% (95% Cl: 88.75%, 96.20%).
Key results: The AUC exceeded 0.95 and sensitivity and specificity both exceeded 80%, meeting the study's primary endpoints.
The BriefCase mean time-to-notification was 70.1 seconds (95% CI: 64.9-75.4) which showed comparability with the primary predicate.
NPV was 99.8% (95% Cl: 99.1% - 99.9%) and PPV was 61.4% (95% Cl: 48.9% - 72.5%).
PLR was 14.2912 (95% Cl: 8.614 - 23.710) and NLR was 0.0206 (95% Cl: 0.005 - 0.082).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
AUC: 0.98 (95% CI: 0.966, 0.994)
Sensitivity: 98.08% (95% CI: 93.23%, 99.77%)
Specificity: 93.14% (95% Cl: 88.75%, 96.20%)
NPV: 99.8% (95% Cl: 99.1% - 99.9%)
PPV: 61.4% (95% Cl: 48.9% - 72.5%)
PLR: 14.2912 (95% Cl: 8.614 - 23.710)
NLR: 0.0206 (95% Cl: 0.005 - 0.082)
Additional Operating Point 1 (AOP1):
Sensitivity: 88.46% (95% C1: 80.71%, 93.89%)
Specificity: 95.1% (95% C1: 91.17%, 97.62%)
Additional Operating Point 2 (AOP2):
Sensitivity: 99.04% (95% Cl: 94.76%, 99.98%)
Specificity: 90.20% (95% Cl: 85.27%, 93.91%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BriefCase (RibFx triage, K202992)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 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 J. Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON DC 20004
February 1, 2023
Re: K230020
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: QFM Dated: January 3, 2023 Received: January 3, 2023
Dear John J. 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration
Indications for Use
510(k) Number (if known)
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast) 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 communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx findings. Notifications include compressed preview images that are meant for informational purposes only, and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
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3
Image /page/3/Picture/0 description: The image shows the logo for Aidoc. The logo is in blue and consists of the word "aidoc" in lowercase letters. The "i", "d", "o", and "c" are all connected. There is a small orange circle to the right of the "c".
510(k) Summary Aidoc Medical, Ltd.'s BriefCase
Submitter:
| Aidoc Medical, Ltd.
92 Yigal Alon St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | Amalia Schreier, LL.M |
| Date Prepared: | January 3, 2023 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Requlatory Class: | Class II |
| Product Code: | QFM (21 C.F.R. 892.2080) |
| Primary Predicate Device: | BriefCase (RibFx triage, K202992) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase receives filtered DICOM Images, and processes them chronologically by running the algorithms on each series to detect suspected cases. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (desktop application). When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, lowguality, grayscale image that is captioned "not for diagnostic use, for prioritization only" which is displayed as a preview function. This 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 efficient triaqe 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 chest CTs (with or without contrast) 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 communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.
4
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx 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 triaqe/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 RibFx triage and the algorithm analysis module for the primary predicate BriefCase for RibFx triage (K202992) are identical in most aspects and differ with respect to their algorithm performance, due to training the subject device on a larger data set. Additional operating points have been added to the pivotal study endpoints. In addition, the SW architecture was changed to separate the image communication platform from the BriefCase SW. The new device consists of only the algorithm analysis module which can be integrated with image communication platforms that meet the BriefCase input and output requirements.
Both the primary predicate and subject devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence, deep-learning algorithms incorporated in software packages for use with DICOM 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 algorithm trained on medical images. Both devices are intended to provide the specialists with notifications and unannotated, compressed, low-quality, and grayscale 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 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 deprioritized 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.
5
| | Predicate Device
Aidoc Briefcase for RibFx triage
(K202992) | Subject Device
Aidoc Briefcase for RibFx triage |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of chest
CTs (with or without contrast). The
device is intended to assist hospital
networks and appropriately trained
medical specialists in workflow triage
by flagging and communication of
suspect cases of three or more acute
Rib fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence
algorithm to analyze images and flag
suspect cases on a standalone desktop
application in parallel to the ongoing
standard of care image interpretation.
The user is presented with notifications
for suspect cases. Notifications include
compressed preview images that are
meant for informational purposes only
and not intended for diagnostic use
beyond notification. The device does
not alter the original medical image and
is not intended to be used as a
diagnostic device.
The results of BriefCase are intended to
be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care. | BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of chest
CTs (with or without contrast) 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 communicating suspect
cases of three or more acute Rib
fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected findings in
parallel to the ongoing standard of care
image interpretation. The user is
presented with notifications for cases
with suspected RibFx findings.
Notifications include compressed
preview images that are meant for
informational purposes only and not
intended for diagnostic use beyond
notification. The device does not alter
the original medical image and is not
intended to be used as a diagnostic
device.
The results of BriefCase are intended to
be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care. |
| User population | Hospital networks and appropriately
trained medical specialists | Hospital networks and appropriately
trained medical specialists |
| | Predicate Device
Aidoc Briefcase for RibFx triage
(K202992) | Subject Device
Aidoc Briefcase for RibFx triage |
| Anatomical region of interest | Chest | Chest |
| Data acquisition protocol | Chest CTs (with or without contrast) | Chest CTs (with or without contrast) |
| 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 app or deprioritized |
| Inclusion/ Exclusion criteria for clinical performance testing | Inclusion criteria
- Chest CTs (with or without contrast).
- Single energy exams.
- Scans performed with a 64 or greater number of detectors.
- Scans performed on adults/transitional adults ≥ 18 years of age.
- Slice thickness; 0.5 - 5.0 mm axial.
Exclusion Criteria - All studies that are technically inadequate, including studies with motion artifacts, severe metal artifacts, or inadequate field of view. | Inclusion criteria
- chest CT with or without contrast
- Single energy exams.
- Performed on CT scanners with 64 or greater number of detectors
- Scans performed on adults/transitional adults ≥ 18 years of age
- Slice thickness; 0.5 mm to 5.0 mm axial slices
Exclusion Criteria - All studies that are technically inadequate, including studies with motion artifacts, severe metal artifacts, or inadequate field of view. |
| 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). | - Integrated with image routing module via image communication platform (ICP) (image acquisition).
- Algorithm module (image processing)
- Integrated with desktop application for workflow integration (feed 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 Chest CTs (with or without contrast) images containing three or more acute Rib fractures (RibFx) in 308 cases from 5 US-based clinical sites. The study compared the software's performance to the ground truth, as determined by three senior board-certified radiologists, using majority voting. 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 pre-specified standalone performance goal (PG) of area under the curve (AUC) > 0.95 for the study level receiver operating characteristic (ROC) curve. Secondary endpoints were BriefCase time-to-notification compared to the predicate device. Positive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), and Negative Likelihood Ratio (NLR) were also assessed.
Primary Endpoint
AUC was 0.98 (95% CI: 0.966, 0.994), Sensitivity was 98.08% (95% CI: 93.23%, 99.77%) and Specificity was 93.14% (95% Cl: 88.75%, 96.20%). As the AUC exceeded 0.95 and sensitivity and specificity both exceeded 80%, the study's primary endpoints were met.
Lower confidence limits for AUC, sensitivity and specificity were all above the pre-specified performance goals, demonstrating that the pre-specified performance goals were met.
Secondary Endpoint
In addition, the time-to-notification metric observed for the BriefCase software, when integrated with a compatible image communication platform, 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 RibFx.
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 the subject RibFx triage was 70.1 seconds (95% CI: 64.9-75.4). The time-tonotification for the predicate RibFx triage was 252 seconds (95% Cl: 234-270).
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| Table 2. Time-to- notification comparison for BriefCase devices (Seconds) | |
|---|---|
| --------------------------------------------------------------------------- | -- |
| Time -to-notification | Mean
Estimate
(seconds) | N | 95% Lower
CL | 95% Upper
CL | Median | IQR |
|-------------------------------------------------------------------------|-------------------------------|-----|-----------------|-----------------|--------|-----|
| Predicate K202992
Processing Time | 252 | 67 | 234 | 270 | 252 | 108 |
| BriefCase + Image
Communication
Platform Time-To-
Notification | 70.1 | 104 | 64.9 | 75.4 | 66 | 59 |
NPV was 99.8% (95% Cl: 99.1% - 99.9%) and PPV was 61.4% (95% Cl: 48.9% - 72.5%).
PLR was 14.2912 (95% Cl: 8.614 - 23.710) and NLR was 0.0206 (95% Cl: 0.005 - 0.082).
Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase for RibFx triage the clinician may have the same benefit in time saving as with the predicate BriefCase for RibFx triage.
As can be seen in Table 3 the mean age of patients whose scans were reviewed for RibFx was 65.1 years, with a standard deviation of 15.5 years. Gender distribution was 51.3% male, and 45.5% female (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) | 65.1 | 15.5 | 20 | 66 | 90 | 308 |
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| Gender | ||||||
|---|---|---|---|---|---|---|
| Ground Truth Results | Female | Male | All | |||
| N | % | N | % | N | % | |
| Positive | 36 | 12.1% | 61 | 20.5% | 97 | 32.6% |
| Negative | 104 | 34.9% | 97 | 32.6% | 201 | 67.4% |
| All | 140 | 47.0% | 158 | 53.0% | 298 | 100.0% |
Table 4. Frequency Distribution of Gender *
- 10 cases were unknown for gender (3 negative and 7 positive).
Table 5. Frequency Distribution of Manufacturer
| Manufacturer | N | % |
|---|---|---|
| GE MEDICAL | ||
| SYSTEMS | 150 | 48.7% |
| Philips | 64 | 20.8% |
| SIEMENS | 53 | 17.2% |
| TOSHIBA | 41 | 13.3% |
| Total | 308 | 100% |
Clinical Subgroups and Confounders:
Pathologies present in negative; Neoplastic; Heart & vascular; Chronic diseases; Inflammatory; Trauma; 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 88.46% (95% C1: 80.71%, 93.89%) and specificity was 95.1% (95% C1: 91.17%, 97.62%).
AOP2: Sensitivity was 99.04% (95% Cl: 94.76%, 99.98%) and specificity was 90.20% (95% Cl: 85.27%, 93.91%).
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 RibFx triage and the predicate BriefCase for RibFx triage are intended to aid in prioritization and triage of radiological images for the indications for suspected positive findings of Rib Fracture (RibFx) pathologies. Both devices are software packages consisting of deep learning Al algorithms that process images and produce analysis results, which are displayed to the user by a prioritization alert and a compressed, low-quality, grayscale, unannotated preview image. 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 RibFx triage is thus substantially equivalent to the primary predicate BriefCase for RibFx.