(254 days)
Viz RV/LV (K221100)
Yes
The device description explicitly states "Following the Al 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 image management and processing system software" intended to "assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement." It explicitly states that "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" and "not for diagnostic use." This indicates it's an aid for measurement and analysis, not a device that directly treats, cures, mitigates, or prevents diseases.
No
The text explicitly states multiple times that the device's measurements are "unofficial," "not final," and "not for diagnostic use," and clarifies that it is intended to "assist" medical specialists but not for "stand-alone basis for clinical decision-making."
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." This indicates it is purely software performing image processing and analysis.
No, 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 analyzes radiological images (CT scans), which are external to the body. It processes these images to measure the diameter of the abdominal aorta.
- No Biological Samples: The device does not interact with or analyze any biological samples from the patient.
Therefore, based on the provided information, BriefCase-Quantification falls under the category of a radiological image processing and analysis system, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 measurement of cases that include the abdominal aorta (M-AbdAo), BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate postoperative aortas.
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 (comma separated list FDA assigned to the subject device)
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 a preview image annotated with the maximum axial diameter measurement. 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 exams with contrast
Anatomical Site
abdominal aorta
Indicated Patient Age Range
adults or transitional adolescents aged 18 and older.
Intended User / Care Setting
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
Not Found
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 maximum axial diameter measurements of the abdominal aorta in CT images in 160 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 was 1.95 mm (95% Cl: 1.59 mm, 2.32 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: 1.95 mm (95% C1: 1.59 mm, 2.32 mm); the reference device: 1.6 mm (95% Cl: 1.5 mm, 1.7 mm)] demonstrates comparable performance.
Additional descriptive statistics and Bland Altman analysis were also reported in the labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
mean absolute error: 1.95 mm (95% Cl: 1.59 mm, 2.32 mm)
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.
Viz RV/LV (K221100)
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.
Al-Rad Companion (Cardiovascular) (K183268)
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
§ 892.2050 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).
0
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Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
November 8, 2023
Re: K230534
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: October 3, 2023 Received: October 3, 2023
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.
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).
1
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.
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-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).
Sincerelv.
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
Indications for Use
510(k) Number (if known) K230534
Device Name BriefCase-Quantification
Indications for Use (Describe)
Brief Case-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 measurement of cases that include the abdominal aorta (M-AbdAo), BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate postoperative aortas.
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/3/Picture/0 description: The image shows the word "aidoc" in a sans-serif font. The word is written in blue, except for the dot on the "i", which is orange. The letters are thick and rounded, giving the word a friendly and approachable appearance. The logo is simple and modern.
K230534
510(k) Summarv K230534 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 05, 2023 |
| 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: | Viz RV/LV (K221100) |
| Reference Device: | Al-Rad Companion (Cardiovascular) (K183268) |
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 a preview image annotated with the maximum axial diameter measurement. 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.
Intended Use / Indications for Use
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Image /page/4/Picture/0 description: The image shows the word "aidoc" in blue font. The letters are lowercase and connected. There is a small orange dot to the right of the letter "c".
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 measurement of cases that include 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 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 the Abdominal Aortic Measurement (M-AbdAo) is substantially similar to primary predicate Viz RV/LV (K221100) and is similar to reference device Al-Rad Companion (Cardiovascular) (K183268), as explained below.
The subject, predicate and the reference 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 predicate Viz RV/LV and the reference Al-Rad Companion (Cardiovascular) evaluate images from CT scanners as does the proposed device for BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo). The subject, predicate and reference devices produce similar outputs that includes a diameter measurement of an anatomical organ image series (Abdominal aorta; Left and right ventricles of the heart; aorta - respectively).
The proposed device for BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) 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 radiological images. The subject, the predicate Viz RV/LV 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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| | Predicate Device Viz
RV/LV (K221100) | Reference Device
Al-Rad Companion
(Cardiovascular)
(K183268) | Subject Device
Aidoc
BriefCase-Quantifica
tion of the
Abdominal Aortic
Measurement
(M-AbdAo) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Viz RV/LV
Software device is
designed to measure
the maximal
diameters of the right
and left ventricles of
the heart from a
volumetric CTPA
acquisition and report
the ratio of those
measurements. Viz
RV/LV analyzes cases
using an artificial
intelligence algorithm
to identify the location
and measurements of
the ventricles. The Viz
RV/LV software
provides the user with
annotated images
showing ventricular
measurements. Its
results are not
intended to be used
on a stand-alone
basis for clinical
decision-making or
otherwise preclude
clinical assessment of
CTPA cases. | 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-Quantificati
on 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-Quantificati
on is indicated to
evaluate normal and
aneurysmal
abdominal aortas and
is not intended to
evaluate
post-operative aortas.
The
BriefCase-Quantificati
on results are not |
| | Predicate Device Viz RV/LV (K221100) | Reference Device Al-Rad Companion (Cardiovascular) (K183268) | Subject Device Aidoc BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) |
| | | 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. | 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. |
| User population | Thoracic radiologists, general radiologists, pulmonologists, cardiologists, or other similar physicians | Radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice | Appropriately trained medical specialists |
| Anatomical region of interest | Left and right ventricles of the heart | Heart, coronary arteries and aorta | Abdominal aorta |
| | Predicate Device Viz
RV/LV (K221100) | Reference Device
Al-Rad Companion
(Cardiovascular)
(K183268) | Subject Device
Aidoc
BriefCase-Quantification of the
Abdominal Aortic
Measurement
(M-AbdAo) |
| Data acquisition
protocol | non-gated CTPA | non-cardiac chest CT | CT exams with contrast that include the abdominal 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 | - Viz RV/LV is hosted
on Viz.ai's Backend
Server and analyzes
applicable CTPA
scans.
- The results are
exported in DICOM
format are sent to a
PACS destination for
review by physicians
to assist in the
assessment. | - Al-Rad Companion
(Cardiovascular) is a
software only image
post-processing
application. | -BriefCase-Quantification, is hosted on a
cloud server, analyzes
applicable CT images
that are acquired on
CT scanner that are
forwarded to
BriefCase-Quantification. - 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 |
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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 maximum axial diameter measurements of the abdominal aorta in CT images in 160 cases, from 6 US-based clinical sites, both academic and community centers, compared to the ground truth, as determined by three US
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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 was 1.95 mm (95% Cl: 1.59 mm, 2.32 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: 1.95 mm (95% C1: 1.59 mm, 2.32 mm); the reference device: 1.6 mm (95% Cl: 1.5 mm, 1.7 mm)] demonstrates comparable performance.
As can be seen in Table 2, the mean age of patients whose scans were reviewed for BriefCase-Quantification of the Abdominal Aortic Measurement was 66.8 years, with a standard deviation of 14.8 years. Gender distribution was 58.8% male, and 40.0% female (Table 3). Scanner distribution can also be found in Table 4 below.
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age | ||||||
| (Years) | 66.8 | 14.8 | 25 | 69 | 90 | 160 |
Table 2. Descriptive Statistics for Age
Table 3. Frequency Distribution of Gender
| Gender | N* | % |
|---|---|---|
| Male | 94 | 58.8% |
| Female | 64 | 40.0% |
- 2 cases had unknown gender defined in the DICOM metadata header and were excluded from the gender distribution
Table 4. Frequency Distribution of Manufacturer
| Manufacturer | N | % |
|---|---|---|
| Siemens | 52 | 32.5% |
| GE | 46 | 28.8% |
| Philips | 39 | 24.4% |
| Toshiba | 23 | 14.4% |
| Total | 160 | 100% |
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Clinical Subgroups and Confounders: Inflammatory; Neoplasm; Trauma; Abdominal Pathologies; Urinary system pathologies and None of the above.
Additional descriptive statistics and Bland Altman analysis were also reported in the labeling.
In summary, performance validation data, combined with a comparison of mean absolute error metric with the reference device demonstrated equivalent performance.
Conclusions
The subject BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo), the predicate Viz RV/LV and the reference device Al-Rad Companion (Cardiovascular) are intended to aid in medical image management and processing of radiological images in CT. The subject, predicate and the reference 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 both devices, the labeling instructs the user that the results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment. The subject and reference device have similar clinical indications and show substantially similar performance.
The BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) device is thus substantially equivalent and is as safe and effective to the Viz RV/LV and Al-Rad Companion (Cardiovascular).