(196 days)
Not Found
Yes
The document explicitly states that the device "uses an artificial intelligence algorithm to analyze images" and mentions "deep learning Al algorithms".
No
The device is described as a "radiological computer-aided triage and notification software" intended to "assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina." It specifically states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device." It focuses on workflow prioritization rather than direct treatment or diagnosis, which are characteristics of therapeutic devices.
No
The document explicitly states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device."
Yes
The device description explicitly states "BriefCase is a radiological computer-assisted triage and notification software device" and details its software components and modules without mentioning any proprietary hardware.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- 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 (frontal chest X-rays) to assist in workflow triage. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for the analysis of radiological images to assist in workflow triage and notification. It explicitly states it is not intended to be used as a diagnostic device.
- Device Description: The device description details software components and image processing, not the analysis of biological specimens.
Therefore, BriefCase falls under the category of a medical device, specifically a radiological computer-assisted triage and notification software, but it is not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of frontal chest X-ray (CXR) 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 suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina.
Findings are flagged when the ETT distal tip is assessed as being more than 5 cm above the carina, less than 2 cm above the carina, or when it is below the carina (i.e., in the right or left mainstem bronchus).
The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device does not provide results when the carina is not wellvisualized on the x-ray image. The device does not discriminate types of ETTs, as such a properly positioned double lumen ETT may trigger a false prioritization alert.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone 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 the user's 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 harbors 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 VO cases, and a neuro-radiologist would opt to divert vertically malpositioned ETT in relation to the carina 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.
Mentions image processing
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.
Aidoc Cloud Server (ACS) for image processing
Mentions AI, DNN, or ML
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation.
Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with DICOM 3.0 compliant x-ray scanners, PACS, and radiology workstations.
Artificial intelligence algorithm with database of images.
incorporating deep learning Al algorithms that process images
Input Imaging Modality
frontal chest X-ray (CXR)
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
Description of the test set, sample size, data source, and annotation protocol
A retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying chest X-ray (CXR) images of vertically malpositioned endotracheal tube (ETT) in relation to the carina in 921 cases from 5 US-based clinical sites. The software's performance was compared to the ground truth as determined by 2 out of 3 majority voting 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.
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 software to evaluate the software's performance in identifying chest X-ray (CXR) images of vertically malpositioned endotracheal tube (ETT) in relation to the carina in 921 cases from 5 US-based clinical sites. The software's performance was compared to the ground truth as determined by 2 out of 3 majority voting senior board-certified radiologists. 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 86.81% (95% C1: 81.02%-91.36%) and Specificity was 92.02% (95% Cl: 89.20%-93.87%).
Secondary Endpoint: In addition, the time-to-notification metric observed for the BriefCase software in the five 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).
The secondary measure of time-to-notification analysis demonstrated that standard of care time-to-exam-open (157.0 minutes: 95% CI: 155.0-159.0; Median: 50.0 IQR: 156.0) was substantially longer than the parallel time-to-notification of the BriefCase for Malpositioned Endotracheal Tube (ETT) device (4.93 minutes, 95% Cl: 4.64-5.22; Median: 4.13 IQR: 0.76). The mean difference of 152.07 minutes between these two measures quantifies effective triage by the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 86.81% (95% C1: 81.02%-91.36%)
Specificity: 92.02% (95% Cl: 89.20%-93.87%)
NPV: 98.43% (95% Cl: 97.74% - 98.92%) at 10% positive prevalence; 96.54% (95% Cl: 95.05% 97.59%) at 20% positive prevalence; 94.21% (95% CI: 91.81% 95.94%) at 30% positive prevalence.
PPV: 54.71% (95% Cl: 48.45% 60.83%) at 10% positive prevalence; 73.11% (95% Cl: 67.89%- 77.75%) at 20% positive prevalence; 82.33% (95% CI: 78.38%- 85.70%) at 30% positive prevalence.
PLR: 10.874 (95% Cl: 8.458-13.979)
NLR: 0.143 (95% Cl: 0.099- 0.208)
Predicate Device(s)
BriefCase (for iPE 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.
0
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Aidoc Medical, Ltd. % John J. Smith Partner Hogan Lovells US LLP 555 Thirteenth Street, N.W. WASHINGTON DC 20004
Re: K221330
November 18, 2022
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: October 11, 2022 Received: October 11, 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 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 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K221330
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of frontal chest X-ray (CXR) 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 suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina.
Findings are flagged when the ETT distal tip is assessed as being more than 5 cm above the carina, less than 2 cm above the carina, or when it is below the carina (i.e., in the right or left mainstem bronchus).
The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device does not provide results when the carina is not wellvisualized on the x-ray image. The device does not discriminate types of ETTs, as such a properly positioned double lumen ETT may trigger a false prioritization alert.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone 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 the user's 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
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510(k) Summary Aidoc Medical, Ltd.'s BriefCase K221330
| Submitter: | Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
Phone: +972-73-7946870 |
|---------------------------|-------------------------------------------------------------------------------------|
| Contact Person: | Amalia Schreier, LLM |
| Date Prepared: | November 17, 2022 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software
device |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Primary Predicate Device: | BriefCase (for iPE 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 harbors 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 VO cases, and a neuro-radiologist would opt to divert vertically malpositioned ETT in relation to the carina 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.
4
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 frontal chest X-ray (CXR) 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 suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina.
Findings are flagged when the ETT distal tip is assessed as being more than 5 cm above the carina, less than 2 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus).
The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device does not provide results when the carina is not well-visualized on the x-ray image. The device does not discriminate types of ETTs, as such a properly positioned double lumen ETT may trigger a false prioritization alert.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone 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 the user's 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 vertically malpositioned ETT in relation to the carina triage and primary predicate BriefCase for iPE triage (K203508) are identical in all aspects and defer only with respect to the training of the algorithm on vertically malpositioned ETT in relation to the images.
Both devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with DICOM 3.0 compliant x-ray scanners, PACS, and radiology workstations. The predicate BriefCase for iPE evaluates images from CT scanners and the proposed Briefcase for vertically malpositioned ETT in relation to the carina evaluates images from X-ray scanners.
The proposed device for vertically malpositioned ETT in relation to the carina triage has identical technology and design as the predicate device, and similar indications for use, i.e., both devices are intended to aid in prioritization and triage of time-critical radiological images. The subject and predicate BriefCase devices raise the same types of safety and effectiveness questions, namely,
5
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 predicate devices is provided below.
| | Predicate Device
Aidoc Briefcase for iPE Triage
(K203508) | Subject Device
Aidoc Briefcase for Vertically
Malpositioned ETT in Relation to the
Carina Triage (K221330) |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast enhanced chest CTs (but not dedicated CTPA protocol). The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging and communication of suspect positive cases of incidental Pulmonary Embolism (iPE) 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 | BriefCase is a radiological computer- aided triage and notification software indicated for use in the analysis of frontal chest X-ray (CXR) 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 suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina.
Findings are flagged when the ETT distal tip is assessed as being more than 5 cm above the carina, less than 2 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus).
The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device does not provide results when the carina is not well-visualized on the x-ray image. The device does not discriminate types of ETTs, as such a properly positioned double lumen ETT may trigger a false prioritization alert.
BriefCase uses an artificial intelligence algorithm to analyze images and |
| | Predicate Device
Aidoc Briefcase for iPE Triage
(K203508) | Subject Device
Aidoc Briefcase for Vertically
Malpositioned ETT in Relation to the
Carina Triage (K221330) |
| | viewing full images per the standard of
care. | highlight cases with detected findings
on a standalone 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 the
user's 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 | Contrast-enhanced chest CTs (but not
dedicated CTPA protocol) | Frontal Chest X-ray (CXR) |
| Notification-
only
(/notification
alerts), parallel
workflow tool | Yes | Yes |
| Images
format | DICOM | DICOM |
| | Predicate Device
Aidoc Briefcase for iPE Triage
(K203508) | Subject Device
Aidoc Briefcase for Vertically
Malpositioned ETT in Relation to the
Carina Triage (K221330) |
| 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 | Inclusion criteria
• Contrast-enhanced chest CTs (but
not dedicated CTPA protocol.
• Single energy exams.
• Scans performed with a 64 slice or
greater number of detectors.
• Scans performed on adults/
transitional adults ≥ 18 years of age.
• Slice thickness: 0.5mm - 2.0mm
axial.
Exclusion Criteria
• All studies that are technically
inadequate, including studies with
motion artifacts, severe metal
artifacts, or inadequate field of view. | Inclusion criteria
• Frontal Chest X-ray protocol.
• Images performed on adults/
transitional adults ≥ 18 years of age.
Exclusion Criteria
• All x-ray images that have
inadequate field of view. The device
does not provide results when the
carina is not well-visualized on the
x-ray image. |
| 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 (orchestrator, image
acquisition);
• ACS module (image processing);
• Aidoc Desktop application for
workflow integration (feed and non-
diagnostic Image Viewer). |
Table 1. Key Feature Comparison
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7
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 X-ray (CXR) images of vertically malpositioned endotracheal tube (ETT) in relation to the carina in 921 cases from 5 US-based clinical sites. The software's performance was compared to the ground truth as determined by 2 out of 3 majority voting 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.
8
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 86.81% (95% C1: 81.02%-91.36%) and Specificity was 92.02% (95% Cl: 89.20%-93.87%).
Secondary Endpoint
In addition, the time-to-notification metric observed for the BriefCase software in the five 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 secondary measure of time-to-notification analysis demonstrated that standard of care time-toexam-open (157.0 minutes: 95% CI: 155.0-159.0; Median: 50.0 IQR: 156.0) was substantially longer than the parallel time-to-notification of the BriefCase for Malpositioned Endotracheal Tube (ETT) device (4.93 minutes, 95% Cl: 4.64-5.22; Median: 4.13 IQR: 0.76). The mean difference of 152.07 minutes between these two measures quantifies effective triage by the device.
| Time-to-notification | Mean
Estimate | N | 95%
Lower CL | 95%
Upper CL | Median | IQR |
|---------------------------------------|------------------|-----|-----------------|-----------------|--------|-------|
| Standard of Care
Time-To-Exam-Open | 157.0 | 197 | 155.0 | 159.0 | 50.0 | 156.0 |
| BriefCase Time-to-
notification | 4.93 | 182 | 4.64 | 5.22 | 4.13 | 0.76 |
Table 2. Time Saving Data (Sec)
NPV was 98.43% (95% Cl: 97.74% - 98.92%), 96.54% (95% Cl: 95.05% 97.59%) and 94.21% (95% CI: 91.81% 95.94%) at 10%, 20% and 30% positive prevalence.
PPV was 54.71% (95% Cl: 48.45% 60.83%), 73.11% (95% Cl: 67.89%- 77.75%) and 82.33% (95% CI: 78.38%- 85.70%) at 10%, 20% and 30% positive prevalence.
PLR was 10.874 (95% Cl: 8.458-13.979) and NLR was 0.143 (95% Cl: 0.099- 0.208).
Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase for vertically malpositioned ETT in relation to the carina triage the radiologists may have the same benefit in time saving as with the BriefCase for iPE triage.
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As can be seen in Table 3 the mean age of patients whose were reviewed for vertically malpositioned ETT in relation to the carina was 62.5 years, with standard deviation of 17.0 years. Gender distribution was 58.52% male, and 41.37% female (Table 4). X-ray scanner distribution can also be found in Table 5 below.
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age | ||||||
| (Years) | 62.5 | 17.0 | 18.0 | 64.0 | 90 | 921 |
Table 3. Descriptive Statistics for Age
| Ground
Truth
| Results | Gender | Male | Female | All | ||||
|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | |||
| Positive | 112 | 12.16 | 70 | 7.60 | 182 | 19.76 |
Table 4. Frequency Distribution of Gender *
- The gender of 1 case remained unknown due to incomplete DICOM tag information
311
381
33.77
41.37
738
920*
80.13
100.0
Negative
All
427
439
46.36
58.52
Table 5. Frequency Distribution of Manufacturer
| Manufacturer | N | % |
|---|---|---|
| Carestream | 358 | 38.9 |
| Canon | 223 | 24.2 |
| Siemens | 186 | 20.2 |
| Philips | 154 | 16.7 |
| Total | 921 | 100% |
Tables 6-8 below detail the distribution of pathologies with and without ETT in negative cases, distribution of ETT in negative cases, distribution of other (no ETT) tubes, lines and life support devices in positive cases.
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| Pathology | N
(w/o
ETT) | %
(w/o ETT) | N
(w/ ETT) | %
(w/ ETT) |
|-----------------------------------------------------------|-------------------|----------------|---------------|---------------|
| Fully Negative | 84 | 11.4% | 0 | 0.0% |
| Other (non ETT ) tubes,lines
and life support devices* | 220 | 29.8% | 164 | 22.2% |
| Inflammatory | 185 | 25.1% | 57 | 7.7% |
| Post op | 133 | 18.0% | 58 | 7.9% |
| Cardiovascular | 94 | 12.7% | 45 | 6.1% |
| Lung pathologies | 46 | 6.2% | 7 | 0.9% |
| Pneumothorax | 36 | 4.9% | 5 | 0.7% |
| Infectious | 33 | 4.5% | 6 | 0.8% |
| Trauma | 14 | 1.9% | 2 | 0.3% |
| Neoplastic | 13 | 1.8% | 3 | 0.4% |
| Chronic diseases | 2 | 0.3% | 0 | 0.0% |
| None of the above | 28 | 3.8% | 7 | 0.9% |
Table 6. Distribution of Pathologies with and without ETT in Negative Cases
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| Pathology | N | % |
|---|---|---|
| With correctly positioned | ||
| ETT | 199 | 26.9% |
| With no ETT | 540 | 73.1% |
Table 7. Distribution of ETT in Negative Cases
Table 8. Distribution of Other (no ETT) Tubes, Lines and Life Support Devices in Positive Cases
| Pathology | N | % |
|---|---|---|
| Other tubes, lines and life | ||
| support devices | 144 | 60.0% |
| No other tubes, lines and | ||
| life support devices | 96 | 40.0% |
Other (non-ETT) tubes, lines & life support devices' includes a variety of tubes, lines, catheters, monitoring devices and other life support devices. For example: enteric tube (nasogastric/orogastric), chest tube, mediastinal drains, internal jugular central venous catheter, PICC, ECMO cannula, EKG leads, Mediport, etc.
Clinical Subgroups And Confounders:
- -Pathologies present in negative cases: Fully Negative; Other (non ETT) tubes, lines and life support devices; Inflammatory; Post op; Cardiovascular; Lung pathologies; Pneumothorax; Infectious; Trauma; Neoplastic; Chronic diseases; None of the above.
- -Tip position sub-types: Too high; Too low (Trachea); Too low (Bronchus); Too low - right mainstem bronchus; Too low - left mainstem bronchus. An additional enriched dataset was collected for Tip position sub-types analysis on 327 positive cases.
Conclusions
The subject BriefCase for vertically malpositioned ETT in relation to the carina triage and the predicate BriefCase for iPE triage are intended to aid in prioritization and triage of radiological images for the indications of malpositioned endotracheal tube and incidental pulmonary embolism, respectively. Both devices are software packages with the same technological characteristics and principles of operation,
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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 vertically malpositioned ETT in relation to the carina triage is thus substantially equivalent to the primary predicate BriefCase for iPE triage.