(29 days)
BriefCase-Triage for CSF (K203508)
BriefCase-Triage for PE (K241727)
Yes
The document explicitly states that the device "uses an artificial intelligence algorithm" and that the "algorithm was trained... As is customary in the field of machine learning algorithm development".
No.
The device is a computer-aided triage and notification software intended to assist in workflow prioritization by flagging and communicating potential findings. It does not perform any direct diagnosis or treatment, and its output is not intended for diagnostic use. It serves to assist medical specialists in prioritizing cases for review, rather than directly treating or diagnosing patients.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device." Additionally, the "Device Description" mentions that preview images are "not for diagnostic use" and "not intended for primary diagnosis beyond notification." The device is intended for workflow triage and notification, to prioritize cases for human review, not to provide a diagnosis itself.
Yes
The device description explicitly states "BriefCase-Triage is a radiological computer-assisted triage and notification software device" and that it "is intended to run on a linuxbased server in a cloud environment." There is no mention of accompanying hardware components that are part of the medical 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-Triage Function: BriefCase-Triage analyzes medical images (CT scans) of the cervical spine. It does not analyze samples taken from the body.
- Intended Use: The intended use is to assist in workflow triage and notification based on image analysis, not to provide a diagnosis based on biological samples.
- Device Description: The device description clearly states it's a radiological computer-assisted triage and notification software device that processes DICOM images.
Therefore, BriefCase-Triage falls under the category of medical imaging software, not in vitro diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, 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 linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase-Triage 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 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-Triage 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)
QAS
Device Description
BriefCase-Triage is a radiological computer-assisted triage and notification software device.
The software is based on an algorithm programmed component and is intended to run on a linuxbased server in a cloud environment.
The BriefCase-Triage 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, low-quality, 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 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.
The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning algorithm development consisted of training on manually labeled ("tagged") images. In that process, critical findings were tagged in all CTs in the training data set.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT scans
Anatomical Site
cervical spine
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
The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning algorithm development consisted of training on manually labeled ("tagged") images. In that process, critical findings were tagged in all CTs in the training data set.
Description of the test set, sample size, data source, and annotation protocol
Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Triage software to evaluate the software's performance in identifying CT scans that include the cervical spine images containing Cervical Spine Fracture (CSF) in 487 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. Test pivotal study data was sequestered from algorithm development activities, and use of the data is managed by appropriate Quality Management System procedures.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pivotal Study Summary: Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Triage software to evaluate the software's performance in identifying CT scans that include the cervical spine images containing Cervical Spine Fracture (CSF) in 487 cases from 6 US-based clinical sites, compared to the ground truth as determined by three senior board-certified radiologists.
Primary endpoints were sensitivity and specificity with an 80% performance goal. Secondary endpoints were BriefCase-Triage 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.
Key Results:
Primary Endpoint: Sensitivity and specificity exceeded the 80% performance goal. Sensitivity was 92.1% (95% Cl: 87.5%, 95.4%) and Specificity was 92.6% (95% Cl: 89.0%, 95.4%).
Secondary Endpoint: The BriefCase-Triage time-to-notification was measured for all True Positive cases and is given in Table 2. The BriefCase-Triage mean time-to-notification for the subject CSF triage was 15.1 seconds (95% Cl: 14.1-16.2). The time-to-notification for the predicate CSF was 234 seconds (95% Cl 228-246).
Additional Operating Points:
AOP1: Sensitivity 95.5% (95% CI: 91.7%- 97.9%), Specificity 86.0% (95% CI: 81.4%- 89.8%)
AOP2: Sensitivity 86.1% (95% CI: 80.6%- 90.6%), Specificity 95.1% (95% CI: 91.9%- 97.3%)
AOP3: Sensitivity 93.6% (95% CI: 89.3%- 96.5%), Specificity 89.5% (95% CI: 85.3%- 92.8%)
AOP4: Sensitivity 87.6% (95% CI: 82.3%- 91.8%), Specificity 93.7% (95% CI: 90.2%- 96.2%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 92.1% (95% Cl: 87.5%, 95.4%)
Specificity: 92.6% (95% Cl: 89.0%, 95.4%)
NPV: 99.1% (95% Cl: 98.5%- 99.4%)
PPV: 58.1% (95% Cl: 47.9%-67.7%)
PLR: 12.4965 (95% Cl: 8.263 - 18.898)
NLR: 0.0855 (95% Cl: 0.053 - 0.137)
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-Triage for CSF (K203508)
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.
BriefCase-Triage for PE (K241727)
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Aidoc Medical, Ltd. % John J. Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON DC 20004
October 18, 2024
Re: K242837
Trade/Device Name: BriefCase-Triage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QAS Dated: September 19, 2024 Received: September 19, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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 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
3
Indications for Use
Submission Number (if known)
Device Name
BriefCase-Triage
Indications for Use (Describe)
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, 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 linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase-Triage 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 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-Triage 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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4
510(k) Summary
Aidoc Medical, Ltd.'s BriefCase-Triage
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | Amalia Schreier, LL.M |
| Date Prepared: | October 17, 2024 |
| Name of Device: | BriefCase-Triage |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Regulatory Class: | Class II |
| Product Code: | QAS |
| Primary Predicate Device: | BriefCase-Triage for CSF (K203508) |
| Reference Device: | BriefCase-Triage for PE (K241727) |
| Device Description: |
BriefCase-Triage is a radiological computer-assisted triage and notification software device.
The software is based on an algorithm programmed component and is intended to run on a linuxbased server in a cloud environment.
The BriefCase-Triage 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, low-quality, 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 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.
The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning algorithm development consisted of training on manually
5
labeled ("tagged") images. In that process, critical findings were tagged in all CTs in the training data set.
Intended Use / Indications for Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, 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 linear lucencies in the cervical spine bone in patterns compatible with fractures.
BriefCase-Triage 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 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-Triage 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.
Summary of Technological Characteristics
The subject BriefCase-Triage for CSF and the algorithm analysis module for the primary predicate BriefCase-Triage for CSF (K203508) are identical in most aspects and differ mostly with respect to their algorithm performance. In addition, the SW architecture was changed to separate the image communication platform from the BriefCase-Triage SW. The subject device consists of only the algorithm analysis module which can be integrated with image communication platforms that meet the BriefCase-Triage 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-Triage devices raise the same types of safety and effectiveness questions, namely, accurate triage 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 de-prioritized 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.
6
| | Subject Device
Aidoc BriefCase-Triage for CSF | Predicate Device
Aidoc BriefCase-Triage for CSF
(K203508) |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use /
Indications
for Use | BriefCase-Triage is a radiological
computer aided triage and notification
software indicated for use in the
analysis of CT scans that include the
cervical spine, 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 linear
lucencies in the cervical spine bone in
patterns compatible with fractures.
BriefCase-Triage 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 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-Triage 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 cervical spine CT
images. 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 linear
lucencies in the cervical spine bone in
patterns compatible with fractures.
BriefCase uses an artificial intelligence
algorithm to analyze images and highlight
cases with detected findings on a
standalone desktop application in parallel
to the ongoing standard of care image
interpretation. The user is presented with
notifications for cases with suspected
findings. Notifications include compressed
preview images that are meant for
informational purposes only and not
intended for diagnostic use beyond
notification. The device does not alter the
original medical image and is not intended
to be used as a diagnostic device.
The results of BriefCase are intended to
be used in conjunction with other patient
information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care. |
| User
population | Hospital networks and appropriately
trained medical specialists | Hospital networks and appropriately
trained medical specialists |
| | Subject Device
Aidoc BriefCase-Triage for CSF | Predicate Device
Aidoc BriefCase-Triage for CSF
(K203508) |
| Anatomical
region of
interest | Cervical Spine | Cervical Spine |
| Data
acquisition
protocol | CT with or without contrast that includes
the cervical spine | Non-contrast cervical spine CT scan |
| Notification-
only
(/notification
alerts),
parallel
workflow
tool | Yes | Yes |
| Images
format | DICOM | DICOM |
| Interference
with
standard
workflow | No. No cases are removed from
desktop app or deprioritized | No. No cases are removed from
desktop app or deprioritized |
| Inclusion/
Exclusion
criteria for
clinical
performance
testing | Inclusion Criteria:
CT with or without contrast that
• includes the cervical spine
(bone and standard kernel)
• Scans performed on
adults/transitional adults ≥ 18
years of age.
• Slice thickness: 0.3 mm - 5.0
mm
Exclusion Criteria
• All studies that have an
inadequate field of view | Inclusion Criteria:
• Non-enhanced cervical spine CT
(bone kernel only).
• Scans performed on
adults/transitional adults ≥ 18
years of age.
• Scans performed on CT scanners
with 64 or greater number of
detectors.
• Slice thickness: 0.625 mm - 2.5
mm axial or 2-3 mm sagittal or 2-3
mm. coronal reconstructions with
bone kernel.
Exclusion Criteria
• All scans that are technically
inadequate, including motion
artifacts, severe metal artifacts, or
an inadequate field of view. |
| Additional
Operating
Points | 4 Additional Operating Points | N/A |
| Algorithm | Artificial intelligence algorithm with
database of images. | Artificial intelligence algorithm with
database of images. |
| | Subject Device
Aidoc BriefCase-Triage for CSF | Predicate Device
Aidoc BriefCase-Triage for CSF
(K203508) |
| Structure | - Integrated with image routing module
via image communication platform (ICP)
(image acquisition).
- Algorithm module (image
processing) | - AHS module ( image acquisition); - ACS module (image processing); |
| | - Integrated with desktop application
for workflow integration (feed and
non-diagnostic Image Viewer). | - 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-Triage software to evaluate the software's performance in identifying CT scans that include the cervical spine images containing Cervical Spine Fracture (CSF) in 487 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. Test pivotal study data was sequestered from algorithm development activities, and use of the data is managed by appropriate Quality Management System procedures.
Primary endpoints were sensitivity and specificity with an 80% performance goal. Secondary endpoints were BriefCase-Triage 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 92.1% (95% Cl: 87.5%, 95.4%) and Specificity was 92.6% (95% Cl: 89.0%, 95.4%).
Secondary Endpoint
In addition, the time-to-notification metric observed for the BriefCase-Triage software, when integrated with a compatible image communication platform, was compared to the equivalent metric of the predicate devices. The BriefCase-Triage 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-Triage time-to-notification was measured for all True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase-Triage device) and is given in Table 2 below. The Table also displays the same metric reported for the predicate BriefCase-Triage PE.
9
The time-to-notification results obtained for the subject BriefCase-Triage device show comparability with the primary predicate with regard to time savings to the standard of care review. The BriefCase-Triage mean time-to-notification for the subject CSF triage was 15.1 seconds (95% Cl: 14.1-16.2). The time-to-notification for the predicate CSF was 234 seconds (95% Cl 228-246).
| Time -to-
Notification | Mean
Estimate | N | 95% Lower
CL | 95% Upper
CL | Median |
|-----------------------------------------------------------------------------------|------------------|-----|-----------------|-----------------|--------|
| | (seconds) | | | | |
| Predicate K203508
Processing Time | 234 | 48 | 228 | 246 | 234 |
| BriefCase-Triage +
Image
Communication
Platform Time-To-
Notification | 15.1 | 202 | 14.1 | 16.2 | 13.4 |
Table 2. Time-to- notification comparison for BriefCase-Triage devices (Seconds)
NPV was 99.1% (95% Cl: 98.5%- 99.4%) and PPV was 58.1% (95% Cl: 47.9%-67.7%) PLR was 12.4965 (95% Cl: 8.263 - 18.898) and NLR was 0.0855 (95% Cl: 0.053 - 0.137).
| Table 3. Sensitivity and Specificity Poolability Across Slice Thicknesses | ||
|---|---|---|
| --------------------------------------------------------------------------- | -- | -- |
| Slice Thickness
| [mm] | Sensitivity | Specificity |
|---|---|---|
| 0.3-1.0 | 93.9% (95% CI: 85.0%-98.3%) | 94.2% (95% CI: 87.8%-97.8%) |
| 1.0-2.0 | 93.5% (95% CI: 85.5%-97.9%) | 88.1% (95% CI: 80.2%-93.7%) |
| 2.0-5.0 | 88.3% (95% CI: 77.4%-95.2%) | 96.3% (95% CI: 89.6%-99.2%) |
Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase-Triage for CSF the clinician may have the same benefit in time saving as with the predicate BriefCase-Triage for CSF.
As can be seen in Table 4 the mean age of patients whose scans were reviewed for CSF was 62.0 years, with a standard deviation of 19.6 years. Gender distribution was 47.2% male, and 49.3% female (Table 5). Scanner distribution can also be found in Table 6 below.
10
Table 4. Descriptive Statistics for Age
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age | ||||||
| (Years) | 62.0 | 19.6 | 18.0 | 65.0 | 90.0 | 487 |
Table 5. Frequency Distribution of Gender *
| Ground
Truth
| Results | Gender | |||||
|---|---|---|---|---|---|---|
| Female | Male | All | ||||
| N | % | N | % | N | % | |
| Positive | 80 | 16.4% | 108 | 22.2% | 188 | 38.6% |
| Negative | 160 | 32.9% | 122 | 25.1% | 282 | 57.9% |
| All | 240 | 49.3% | 230 | 47.2% | 487* | 100% |
- 17 cases were unknown for gender, 3 negative and 14 positive.
Table 6. Frequency Distribution of Manufacturer
| Manufacturer | N | % |
|---|---|---|
| GE MEDICAL | ||
| SYSTEMS | 150 | 30.8% |
| SIEMENS | 132 | 27.1% |
| TOSHIBA | 122 | 25.1% |
| Philips | 83 | 17.0% |
| Total | 487 | 100% |
Clinical Subgroups and Confounders:
Pathologies present in negative cases: Oncology; Trauma; Neuro & Vascular; Chronic Spinal Diseases and None of the above.
Additional Operating Points:
In addition to the default operating point that was selected to maximize both sensitivity and specificity, four additional operating points (AOP) were selected to maximize specificity while maintaining a lower bound 95% confidence interval of 80% for sensitivity and spectively:
11
| Operating Points | Sensitivity % (95% CI) | Specificity % (95% CI) |
|---|---|---|
| AOP1 | 95.5% (95% CI: 91.7%- 97.9%) | 86.0% (95% CI: 81.4%- 89.8%) |
| AOP2 | 86.1% (95% CI: 80.6%- 90.6%) | 95.1% (95% CI: 91.9%- 97.3%) |
| AOP3 | 93.6% (95% CI: 89.3%- 96.5%) | 89.5% (95% CI: 85.3%- 92.8%) |
| AOP4 | 87.6% (95% CI: 82.3%- 91.8%) | 93.7% (95% CI: 90.2%- 96.2%) |
Table 7. Additional Operating Points
In summary, performance goals were achieved for the default and four additional operating points. Combined with the comparison results of time-to-notification metric with the predicate device, these data establish the achievement by the subject BriefCase-Triage of preemptive triage in the range of several minutes.
Conclusions
The subject BriefCase-Triage for CSF and the predicate BriefCase-Triage for CSF (K203508) are intended to aid in prioritization and triage of radiological images for the indications for suspected positive findings of Cervical Spine Fracture 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 technological characteristics of both devices are identical with the exception of additional operating points and minor changes in inclusion and exclusion criteria. These differences do not raise new questions of safety and effectiveness. Thus, the subject device is substantially equivalent. The subject BriefCase-Triage device for CSF is thus substantially equivalent to the primary predicate BriefCase-Triage for CSF (K203508).