(119 days)
Al-Rad Companion (Cardiovascular) (K222360)
Yes
The device description explicitly states "Following the AI processing, the output of the algorithm analysis is transferred to an image review software". Additionally, the "Mentions AI, DNN, or ML" field is marked as "Yes".
No.
The device is described as a "radiological medical image management and processing device" that provides measurements to assist medical specialists, but its output is "not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases" and explicitly states "Not for diagnostic use."
No
The device is explicitly stated not to be for diagnostic use ("Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist.") and its results are "not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases." It is intended to assist medical specialists by providing measurements, which are then subject to review and final clinical assessment by a radiologist.
Yes
The device description explicitly states that BriefCase-Quantification is a "radiological medical image management and processing device" and that the "software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment." It receives and processes DICOM images, and its output is transferred to image review software. There is no mention of any accompanying hardware component that is part of the regulated 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-Quantification's Function: BriefCase-Quantification processes and analyzes radiological images (CT scans), which are external to the body. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for the analysis of contrast-enhanced CT exams.
Therefore, BriefCase-Quantification falls under the category of medical image processing software, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text explicitly says "Control Plan Authorized (PCCP) and relevant text Not Found".
Intended Use / Indications for Use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older.
BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas.
The device provides the following assessments:
- Aortic measurements at 10 anatomical landmarks;
- Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.
Product codes
QIH
Device Description
BriefCase-Quantification is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase-Quantification receives filtered DICOM Images, and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (desktop application), and forwarded to user review in the PACS.
The BriefCase-Quantification produces images and tabular views of the landmarks and segments selected per installation to be displayed in the image review software, provided by the Image Communication Platform integrated with Briefcase-Quantification. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist."
BriefCase-Quantification is not intended to evaluate post-operative aortas.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
Aorta
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
Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Quantification software to evaluate the software's performance in providing quantitative diameter measurements across a set of 10 aorta landmarks and measurements of the maximum aortic diameter at three segments abdominal ascending, and descending in contrast-enhanced CT exams that include the aorta in 212 cases, from 6 US-based clinical sites, both academic and community centers, compared to the ground truth, as determined by three US board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time and/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-Quantification software to evaluate the software's performance in providing quantitative diameter measurements across a set of 10 aorta landmarks and measurements of the maximum aortic diameter at three segments abdominal ascending, and descending in contrast-enhanced CT exams that include the aorta in 212 cases, from 6 US-based clinical sites, both academic and community centers, compared to the ground truth, as determined by three US board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm.
Primary Endpoint: The algorithm performance showed that the mean absolute error between the ground truth measurement and algorithm across all landmarks and across all studies was 1.88 mm (95% Cl: 1.78 mm, 1.99 mm). Because the mean absolute error estimate was below the prespecified performance goal, the study's primary endpoint was achieved. The reported similar mean absolute error [the subject device: 1.88 mm (95% Cl: 1.78 mm, 1.99 mm); the predicate device: 1.95 mm (95% Cl: 1.59 mm, 2.32 mm)] demonstrates comparable performance.
Performance testing results for the Bland-Altman analysis is reported below: The mean difference between the ground truth compared to the algorithm output is 0.1 mm, indicating that there is little to no bias between the two measurements, demonstrating the study's secondary endpoint was achieved.
In summary, performance validation data, combined with a comparison of mean absolute error metric with the primary predicate device demonstrated equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean absolute error between the ground truth measurement and algorithm across all landmarks and across all studies: 1.88 mm (95% Cl: 1.78 mm, 1.99 mm).
Mean difference between the ground truth compared to the algorithm output: 0.1 mm.
Predicate Device(s)
BriefCase-Quantification of M-AbdAo (K241112)
Reference Device(s)
Al-Rad Companion (Cardiovascular) (K222360)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
November 22,2024
Re: K242203
Trade/Device Name: BriefCase-Quantification Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: July 26, 2024 Received: October 22, 2024
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 (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.
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2
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" (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 (QS) 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-udi-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 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-regulatory
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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 Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
BriefCase-Quantification
Indications for Use (Describe)
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older.
BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas.
The device provides the following assessments:
- · Aortic measurements at 10 anatomical landmarks;
- · Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. 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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Image /page/4/Picture/1 description: The image shows the logo for Aidoc. The logo is in blue, except for a small orange dot at the end. The logo is simple and modern.
510(k) Summary
Aidoc Medical, Ltd.'s BriefCase-Quantification
Submitter:
Aidoc Medical, Ltd. | |
---|---|
3 Aminadav St. | |
Tel-Aviv, Israel | |
Phone: +972-73-7946870 | |
Contact Person: | Amalia Schreier, LL.M. |
Date Prepared: | November 21, 2024 |
Name of Device: | BriefCase-Quantification |
Classification Name: | Medical image management and processing system |
Regulatory Class: | Class II |
Product Code: | QIH (21 C.F.R. 892.2050) |
Primary Predicate Device: | BriefCase-Quantification of M-AbdAo (K241112) |
Reference Device:Al-Rad Companion (Cardiovascular) (K222360)
Device Description
BriefCase-Quantification is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase-Quantification receives filtered DICOM Images, and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (desktop application), and forwarded to user review in the PACS.
The BriefCase-Quantification produces images and tabular views of the landmarks and segments selected per installation to be displayed in the image review software, provided by the Image Communication Platform integrated with Briefcase-Quantification. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist."
BriefCase-Quantification is not intended to evaluate post-operative aortas.
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Intended Use / Indications for Use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older.
BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas.
The device provides the following assessments:
- . Aortic measurements at 10 anatomical landmarks;
- Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. ●
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.
Comparison of Technological Characteristics
The subject BriefCase-Quantification of Aortic Measurement (M-Aorta) is substantially similar to primary predicate BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) (K241112) and is similar to the reference device Al-Rad Companion (Cardiovascular) (K222360), as explained below.
All three devices are radiological computer-aided medical image management and processing software. All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners. PACS, and radiology workstations. The primary predicate BriefCase-Quantification of M-AbdAo and the reference Al-Rad Companion (Cardiovascular) evaluate images from CT scanners as does the proposed device for BriefCase-Quantification of Aortic Measurement (M-Aorta). The devices produce similar outputs that include a diameter measurement image series of certain segments of the aorta (abdominal, ascending and descending aorta; abdominal aorta; ascending and descending aorta - respectively).
The proposed device for BriefCase-Quantification of Aortic Measurement (M-Aorta) has similar technology and design as the primary predicate device and the reference device, and similar indications for use, i.e., all three devices are intended to aid in measurement of the aorta in radiological images. The subject, the predicate BriefCase-Quantification of M-AbdAo and the reference Al-Rad Companion (Cardiovascular) devices raise the same types of safety and effectiveness questions. A table comparing the key features of the subject device, the primary predicate device and the reference predicate device is provided below.
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Table 1. Key feature comparison
| | Predicate Device
BriefCase-
Quantification of the
Abdominal Aortic
Measurement (M-AbdAo) (K241112) | Reference Device Al-Rad Companion
(Cardiovascular)
(K222360) | Subject Device
Aidoc BriefCase-
Quantification of
Aortic Measurement
(M-Aorta) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | BriefCase-
Quantification is a
radiological image
management and
processing system
software indicated for
use in the analysis of
CT exams with
contrast, that include
the abdominal aorta, in
adults or transitional
adolescents aged 18
and older.
The device is intended
to assist appropriately
trained medical
specialists by
providing the user with
the maximum
abdominal aortic axial
diameter of cases that
includes the
abdominal aorta (M-
AbdAo). BriefCase-
Quantification is
indicated to evaluate
normal and
aneurysmal abdominal
aortas and is not
intended to evaluate
post-operative aortas.
The BriefCase-
Quantification results
are not intended to be | Al-Rad Companion
(Cardiovascular) is
image processing
software that provides
quantitative and
qualitative analysis
from previously
acquired Computed
Tomography DICOM
images to support
radiologists and
physicians from
emergency medicine,
specialty care, urgent
care, and general
practice in the
evaluation and
assessment of
cardiovascular
diseases.
It provides the
following functionality:
- Segmentation and
volume measurement
of the heart - Quantification of the
total calcium volume in
the coronary arteries - Segmentation of the
aorta - Measurement of
maximum diameters of
the aorta at typical
landmarks | BriefCase-
Quantification is a
radiological image
management and
processing system
software indicated for
use in the analysis of
contrast-enhanced CT
exams that include the
aorta in adults or
transitional
adolescents aged 18
and older.
BriefCase-
Quantification of Aortic
Measurement (M-
Aorta) is intended to
assist hospital
networks and
appropriately trained
medical specialists by
providing the user with
aortic diameter
measurements across
the aorta. BriefCase-
Quantification is
indicated to evaluate
normal and
aneurysmal aortas and
is not intended to
evaluate post-
operative aortas. |
| Predicate Device
BriefCase-
Quantification of the
Abdominal Aortic
Measurement (M-
AbdAo) (K241112) | Reference Device Al-
Rad Companion
(Cardiovascular)
(K222360) | Subject Device
Aidoc BriefCase-
Quantification of
Aortic Measurement
(M-Aorta) | |
| used on a stand-alone
basis for clinical
decision-making or
otherwise preclude
clinical assessment of
cases.
These measurements
are unofficial, are not
final, and are subject to
change after review by
a radiologist. For final
clinically approved
measurements, please
refer to the official
radiology report.
Clinicians are
responsible for viewing
full images per the
standard of care. | Threshold-based
highlighting of
enlarged diameters
The software has been
validated for non-
cardiac chest CT data
with filtered
backprojection
reconstruction from
Siemens Healthineers,
GE Healthcare,
Philips, and
Toshiba/Canon.
Additionally, the
calcium detection
feature has been
validated on non-
cardiac chest CT data
with iterative
reconstruction from
Siemens Healthineers.
Only DICOM images
of adult patients are
considered to be valid
input. | The device provides
the following
assessmnets:
● Aortic
measurements at 10
anatomical landmarks;
● Maximum
aortic diameter of
the abdominal
aorta, descending
aorta and
ascending aorta.
The BriefCase-
Quantification results
are not intended to be
used on a stand-alone
basis for clinical
decision-making or
otherwise preclude
clinical assessment of
cases.
These measurements
are unofficial, are not
final, and are subject to
change after review by
a radiologist. For final
clinically approved
measurements, please
refer to the official
radiology report.
Clinicians are
responsible for viewing | |
| | Predicate Device
BriefCase-
Quantification of the
Abdominal Aortic
Measurement (M-
AbdAo) (K241112) | Reference Device Al-
Rad Companion
(Cardiovascular)
(K222360) | Subject Device
Aidoc BriefCase-
Quantification of
Aortic Measurement
(M-Aorta) |
| | | | full images per the
standard of care. |
| User population | Appropriately trained
medical specialists | Radiologists and
physicians from
emergency medicine,
specialty care, urgent
care, and general
practice | Hospital networks and
appropriately trained
medical specialists |
| Anatomical region of
interest | Abdominal aorta | Heart, coronary
arteries and aorta | Aorta |
| Data acquisition
protocol | CT exams with
contrast that include
the abdominal aorta | non-cardiac chest CT | contrast-enhanced CT
exams that include the
aorta |
| Diameter
Measurement | Yes | Yes | Yes |
| Images
format | DICOM | DICOM | DICOM |
| Interference with
standard workflow | No | No | No |
| Algorithm | Artificial intelligence
algorithm with
database of images. | Artificial intelligence
algorithm with
database of images. | Artificial intelligence
algorithm with
database of images. |
| Structure | -BriefCase-
Quantification,
is hostedon a cloud
server, analyzes
applicable CT images
that are acquired on
CT scanner that are
forwarded to
BriefCase-
Quantification. | - The system remains
hosted in the teamplay
digital health platform
and remains driven by
the Al-Rad Companion
Engine.
- The edge
deployment the
processing of clinical | - BriefCase-
Quantification is
hosted on a cloud
server, analyzes
applicable CT images
that are forwarded to
BriefCase-
Quantification. - The results of the
analysis are exported |
| Predicate Device
BriefCase-
Quantification of the
Abdominal Aortic
Measurement (M-
AbdAo) (K241112) | Reference Device Al-
Rad Companion
(Cardiovascular)
(K222360) | Subject Device
Aidoc BriefCase-
Quantification of
Aortic Measurement
(M-Aorta) | |
| - The results of the
analysis are exported
in DICOM format, and
are sent to a PACS
destination for review
by medical specialists,
to assist in the
measurement of the
abdominal aorta. | data and the
generation of
results are performed
within the customer
environment. - This system remains
fully connected to the
cloud for monitoring
and maintenance of
the system from a
remote setup. | in DICOM format, and
are sent to a PACS
destination for review
by medical specialists,
to assist in the
measurement of the
abdominal aorta. | |
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Performance Data
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Quantification software to evaluate the software's performance in providing quantitative diameter measurements across a set of 10 aorta landmarks and measurements of the maximum aortic diameter at three segments abdominal ascending, and descending in contrast-enhanced CT exams that include the aorta in 212 cases, from 6 US-based clinical sites, both academic and community centers, compared to the ground truth, as determined by three US board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm.
Primary Endpoint
The algorithm performance showed that the mean absolute error between the ground truth measurement and algorithm across all landmarks and across all studies was 1.88 mm (95% Cl: 1.78 mm, 1.99 mm). Because the mean absolute error estimate was below the prespecified performance goal, the study's primary endpoint was achieved.
The reported similar mean absolute error [the subject device: 1.88 mm (95% Cl: 1.78 mm, 1.99 mm); the predicate device: 1.95 mm (95% Cl: 1.59 mm, 2.32 mm)] demonstrates comparable performance.
As can be seen in Table 2, the mean age of patients whose scans were reviewed for BriefCase-Quantification of Aortic Measurement (M-Aorta) was 63.2 years, with a standard deviation of 19.3 years. Gender distribution was 49.8% male, and 50.2% female (Table 3). Scanner distribution can also be found in Table 4 below.
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Mean | Std | Min | Median | Max | N | |
---|---|---|---|---|---|---|
Age | ||||||
(Years) | 63.0 | 19.3 | 18.0 | 67.0 | 90.0 | 212 |
Table 2. Descriptive Statistics for Age
Table 3. Frequency Distribution of Gender
Gender | N* | % |
---|---|---|
Male | 106 | 50% |
Female | 106 | 50% |
Table 4. Frequency Distribution of Manufacturer
Manufacturer | N | % |
---|---|---|
Siemens | 58 | 27.4% |
GE | 49 | 23.1% |
Philips | 50 | 23.6% |
Toshiba | 55 | 25.9% |
Total | 212 | 100% |
Clinical Subgroups and Confounders: Aortic Aneurysm; Vasculitis, penetrating atherosclerotic ulcer, and mural thrombus; Aortic calcification/atherosclerosis; Aortic dissection; Retroperitoneal lymphadenopathy / enlarged para-aortic nodes and None of the above.
Performance testing results for the Bland-Altman analysis is reported below:
The mean difference between the ground truth compared to the algorithm output is 0.1 mm, indicating that there is little to no bias between the two measurements, demonstrating the study's secondary endpoint was achieved.
In summary, performance validation data, combined with a comparison of mean absolute error metric with the primary predicate device demonstrated equivalent performance.
Conclusions
The subject BriefCase-Quantification of Aortic Measurement (M-Aorta), the primary predicate BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) and the reference device
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Al-Rad Companion (Cardiovascular) are intended to aid in medical image management and processing of radiological images in CT. The devices are not intended to be used as diagnostic devices. All three devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning AI algorithms that process images. They additionally operate in parallel to the standard of care workflow in the sense that they have the potential to allow accurate measurement and facilitate the standard manual workflow.
In all devices, the labeling instructs the user that the results are not intended to be used on a standalone basis for clinical decision making or otherwise preclude clinical assessment. The subject and predicate device have similar clinications and show substantially similar performance.
The BriefCase-Quantification of Aortic Measurement (M-Aorta) device demonstrates substantial equivalence to the BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) and Al-Rad Companion (Cardiovascular).