(176 days)
HealthCCSng (K210085)
Yes
The device description explicitly states "Following the AI processing..." and the "Mentions AI, DNN, or ML" field is marked as "Yes".
No.
The device is intended to assist physicians by providing a four-category Coronary Artery Calcification (CAC) score for risk assessment and informational purposes, not to directly treat or prevent a medical condition.
Yes
This device is a diagnostic device because it analyzes medical images (non-cardiac-gated non-contrast CT scans) to quantify Coronary Artery Calcification (CAC), which is a risk factor for coronary artery disease. While its results are not intended for stand-alone clinical decision-making, it assists physicians in diagnosing and assessing patient risk by providing actionable information extracted from medical data. The device provides a "four-category Coronary Artery Calcification (CAC) of plaques" and "preview axial images of the detected calcium meant for informational purposes only," ultimately aiding in the diagnostic process by assisting physicians in understanding a patient's condition.
Yes
The device description explicitly states "BriefCase-Quantification is a standalone software as a medical device". It processes existing CT images and outputs a report and visualizations within existing image review software (PACS or desktop application). There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to assist physicians by providing a four-category Coronary Artery Calcification (CAC) of plaques, which present a risk for coronary artery disease. While it states the results are not intended for stand-alone clinical decision-making, the core function is to analyze biological information (calcium deposits in coronary arteries) from a sample (CT images) to provide information about a patient's health status (risk for coronary artery disease).
- Device Description: It processes CT scans to evaluate calcified plaques in the coronary arteries and generates a categorized output corresponding to the estimated quantity of calcium detected. This is a direct analysis of biological material (calcium) within the body, captured through imaging.
- Comparison to Predicate Device: The predicate device listed, K210085 HealthCCSng, is also a software for coronary artery calcium scoring from CT images. Devices with this intended use are typically classified as IVDs.
- Comparison to Reference Device: The reference device listed, K230223 iCAC, is also a software for coronary artery calcium scoring from CT images. Devices with this intended use are typically classified as IVDs.
While the input is an image and the output is a software-generated category, the underlying purpose is to analyze biological markers (calcium) within the patient's body to provide diagnostic information about a disease risk. This aligns with the definition of an In Vitro Diagnostic device, even though the "sample" is an image derived from the patient rather than a traditional biological fluid or tissue sample. The analysis is performed "in vitro" in the sense that it's done outside the patient's body on the acquired image data.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart in adult patients aged 30 and older.
The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calcification (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only.
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. Clinicians are responsible for viewing full images per the standard of care.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
BriefCase-Quantification is a standalone software as a medical device intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart to assist hospital networks and appropriately trained medical specialists. 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 routine, non-gated computed tomography (CT) scans, and processes them chronologically by running the algorithm on relevant series to evaluate calcified plaques in the coronary arteries. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application).
The device generates a four-category output corresponding with the estimated quantity of calcium detected: very low, low, medium, and high. The categories composing the output of the device correspond with a validated visual assessment categorization of none, mild, moderate, and severe [1] in agreement with categorized Agatston scores indicated in the literature (very low: 0; low: 1-100; medium: 101-400; high: ≥400). In addition, the categories accord with the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast non-cardiac chest CT scans and are used as standard of care in clinical practice during CAC assessment in NCCT scans.
The BriefCase-Quantification software generates a preliminary summary report that is provided in the desktop application that includes applicable user warnings, the CAC detection category and number of slices that include CAC. The report presents preliminary results only and instructs the user to review the full image and any other clinical information before making a clinical decision. For all analyzed scans, the user will be presented in the PACS with all the slices containing the measured coronary calcifications. On these images, the calcified areas will be represented to provide the user visibility on the areas which supported the category output. These slices will be presented along with the original slices. Preview images of the represented calcium are non-diagnostic and are available in the PACS for informational purposes only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions AI: "Following the Al processing, the output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application)."
Mentions deep-learning: "All three devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning Al algorithms that process images."
Input Imaging Modality
non-cardiac-gated non-contrast CT (NCCT)
Anatomical Site
Heart (included in images), Chest (anatomical region of interest for subject, predicate, and reference devices)
Indicated Patient Age Range
adult patients aged 30 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 estimated coronary artery calcification detection category from non-cardiac-gated NCCT images that include the heart in 433 cases from 6 US-based clinical sites, both academic and community centers, compared to the ground truth. In cases where the reviewers disagree on the level of CAC, the senior US board-certified radiologist provided a final opinion which has established the ground truth. 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:
Retrospective, blinded, multicenter study.
Sample size: 433 cases.
Primary Endpoint: The algorithm performance showed that the overall agreement between the ground truth and algorithm across estimated CAC scores was 87.1%. Because the overall agreement estimate was up to the prespecified performance goal, the study's primary endpoint was achieved.
Secondary Endpoint: The algorithm performance between the ground truth and algorithm, in individual categories, was as follows: very low = 95.1%; low = 81.3%; medium = 81.5%; and high =89.3% . Because the overall agreement estimate was up to the prespecified performance goal across all individual categories, the study's secondary endpoint was achieved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement: 87.1%
Agreement by category:
Very low: 95.1%
Low: 81.3%
Medium: 81.5%
High: 89.3%
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.
HealthCCSng (K210085)
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.
iCAC (K230223)
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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November 28, 2023
Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON, DC 20004
Re: K231631
Trade/Device Name: BriefCase-Quantification Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 30, 2023 Received: October 30, 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).
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Page 2
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 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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems 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
2
Food and Drug Administration
Indications for Use
See PRA Statement below
510(k) Number (if known)
Device Name
BriefCase-Quantification
Indications for Use (Describe)
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart in adult patients aged 30 and older.
The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calofication (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for dinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.
Type of Use (Select one or both, as applicable)
区 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 logo for Aidoc. The logo is in blue and consists of the word "aidoc" in lowercase letters. There is a small orange circle to the right of the letter "c".
510(k) Summarv Aidoc Medical, Ltd.'s BriefCase-Quantification K231631
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: +972-73-7946870 | |
|---|---|
| Contact Person: | Amalia Schreier, LL.M. |
| Date Prepared: | November 27, 2023 |
| Name of Device: | BriefCase-Quantification |
| Classification Name: | Computed Tomography X-ray System |
| Regulatory Class: | Class II |
| Product Code: | JAK (21 CFR 892.1750) |
| Primary Predicate Device: | HealthCCSng (K210085) |
| Reference Device: | iCAC (K230223) |
Device Description
BriefCase-Quantification is a standalone software as a medical device intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart to assist hospital networks and appropriately trained medical specialists. 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 routine, non-gated computed tomography (CT) scans, and processes them chronologically by running the algorithm on relevant series to evaluate calcified plaques in the coronary arteries. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application).
The device generates a four-category output corresponding with the estimated quantity of calcium detected: very low, low, medium, and high. The categories composing the output of the device correspond with a validated visual assessment categorization of none, mild, moderate, and severe [1] in agreement with categorized Agatston scores indicated in the literature (very low: 0; low: 1-100; medium: 101-400; high: ≥400). In addition, the categories accord with the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast non-cardiac chest CT scans and are used as standard of care in clinical practice during CAC assessment in NCCT scans.
The BriefCase-Quantification software generates a preliminary summary report that is provided in the desktop application that includes applicable user warnings, the CAC detection category and number
4
of slices that include CAC. The report presents preliminary results only and instructs the user to review the full image and any other clinical information before making a clinical decision. For all analyzed scans, the user will be presented in the PACS with all the slices containing the measured coronary calcifications. On these images, the calcified areas will be represented to provide the user visibility on the areas which supported the category output. These slices will be presented along with the original slices. Preview images of the represented calcium are non-diagnostic and are available in the PACS for informational purposes only.
References:
[1] Shemesh, J., Henschke, C.I., Shaham, D., Yip, R., Farooqi, A.O., Cham, M.D., McCauley, D.I., Chen, M., Smith, J.P., Libby, D.M. and Pasmantier, M.W., 2010. Ordinal scoring of coronary artery calcifications on low-dose CT scans of the chest is predictive of death from cardiovascular disease. Radiology, 257(2), pp.541-548.
Intended Use / Indications for Use
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated noncontrast CT (NCCT) images that include the heart in adult patients aged 30 and older.
The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calcification (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only.
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. Clinicians are responsible for viewing full images per the standard of care.
Comparison of Technological Characteristics
The subject BriefCase-Quantification for Coronary Artery Calcification (CAC) is substantially similar to primary predicate HealthCCSng (K210085) and to reference device iCAC (K230223), as explained below.
The subject, predicate and the reference devices are radiological computer-aided non-invasive postprocessing software. All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations. The predicate HealthCCSng and the reference iCAC evaluate images from CT scanners as does the proposed device for BriefCase-Quantification for Coronary Artery Calcification (CAC). The reference and subject devices have four coronary calcium levels and detection categories.
The proposed device for BriefCase-Quantification for Coronary Artery Calcification (CAC) has similar technology and design as the predicate and reference devices, and similar indications for use - as all devices are intended to aid in the evaluation of radiological images. The subject, predicate and reference devices raise the same types of safety and effectiveness questions. A table comparing the key features of the subject device predicate and reference devices is provided below.
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| | Primary Predicate
Device HealthCCSng
(K210085) | Reference Device iCAC
(K230223) | BriefCase-Quantification
for Coronary Artery
Calcification (CAC) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The HealthCCSng device
is intended for use as a
non-invasive post-
processing software to
evaluate calcified plaques
in the coronary arteries,
which present a risk for
coronary artery disease.
The software generates an
estimated coronary artery
calcium detection
category. The
HealthCCSng device
analyzes existing non-
cardiac-gated CT studies
that include the heart of
adult patients above the
age of 30. The device
generates a three-
category output
representing the estimated
quantity of calcium
detected together with
preview axial images of the
detected calcium meant for
informational purposes
only. The device output will
be available to the
radiologist as part of their
standard workflow. The
HealthCCSng results are
not intended to be used on
a stand-alone basis for risk
attribution, clinical
decision-making or
otherwise preclude clinical
assessment of CT studies. | iCAC is a software device
intended for use in
estimating presence and
quantity of coronary artery
calcium for patients aged
30 years and above during
routine care. The device
automatically analyzes
non-gated, non-contrast
chest computed
tomography (CT) images
collected during routine
care and outputs a visual
representation of
estimated coronary artery
calcium segmentation
(intended for informational
purposes only) and both
exact and four-category
quantitative estimates of
the patient's coronary
artery calcium burden in
Agatston units.
The output of the subject
device is made available to
the physician on-demand
as part of his or her
standard workflow. The
device-generated calcium
score or score group can
be viewed in the patient
report at the discretion of
the physician, and the
physician also has the
option of viewing the
device-generated calcium
segmentation in a | BriefCase-Quantification is a
software intended for use in
the analysis of non-cardiac-
gated non-contrast CT
(NCCT) images that include
the heart in adult patients
aged 30 and older.
The device is intended to
assist physicians by
providing the user with a four-
category Coronary Artery
Calcification (CAC) of
plaques, which present a risk
for coronary artery disease,
together with preview axial
images of the detected
calcium meant for
informational purposes only.
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.
Clinicians are responsible for
viewing full images per the
standard of care. |
| | Primary Predicate
Device HealthCCSng
(K210085) | Reference Device iCAC
(K230223) | BriefCase-Quantification
for Coronary Artery
Calcification (CAC) |
| | | diagnostic image viewer.
The subject device output
in no way replaces the
original patient report or
the original chest CT scan;
both are still available to be
viewed and used at the
discretion of the physician. | |
| | | The device is intended to
provide information to the
physician to provide
assistance during review of
the patient's case. Results
of the subject device are
not intended to be used on
a stand-alone basis and
are solely intended to aid
and provide information to
the physician. In all cases,
further action taken on a
patient should only come
at the recommendation of
the physician after further
reviewing the patient's
results. | |
| User population | Radiologists | Interpreting physicians | Hospital networks and
appropriately trained medical
specialists |
| Anatomical region
of interest | Chest | Chest | Chest |
| Data acquisition
protocol | Non-cardiac-gated CT
studies that include the
heart | Non-gated, non-contrast
chest CT images | Non-cardiac-gated non-
contrast CT images that
include the heart |
| | Primary Predicate
Device HealthCCSng
(K210085) | Reference Device iCAC
(K230223) | BriefCase-Quantification
for Coronary Artery
Calcification (CAC) |
| Calcified plaques
evaluation | Yes | Yes | Yes |
| 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. |
| Slice Thickness | Up to 3.0 mm | Up to 5.0 mm | Up to 5.0 mm |
| Patient population | Patients aged 30 and older | Patients aged 30 and older | Patients aged 30 and older |
| Default threshold
of calcium | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) |
| Report of the
calcium score -
output | Yes, Coronary Calcium
Detection Category.
3 categories:
• 0-99
• 10-399
• >400 | Yes, Coronary Calcium
Detection Category and
exact Agatston score.
4 categories (for detection
category):
• 0
• 1-99
• 100-399
• >_400 | Yes, Coronary Calcium
Detection Category: very low,
low, medium, and high.
• The categories
composing the output
of the device
correspond with a
validated visual
assessment
categorization of
none, mild, moderate,
and severe in
agreement with
categorized Agatston
scores indicated in
the literature (very
low: 0; low: 1-100;
medium: 101-400;
high: ≥400). |
| Structure | -
HealthCCSng is an
algorithm module
that receives a
non-cardiac-gated
CT study from the | -
The iCAC Device
takes as an input
non-contrast, non-
gated chest CT
scans via DICOM | -
BriefCase-
Quantification, is
hosted on a cloud
server, analyzes
applicable CT images |
| Primary Predicate
Device HealthCCSng
(K210085) | Reference Device iCAC
(K230223) | BriefCase-Quantification
for Coronary Artery
Calcification (CAC) | |
| storage
application,
Zebra's Imaging
Analytics Platform
(IMA). | transfer from the
clinicians imaging
database such as
PACS or DICOM
router. | that are acquired on
CT scanner that are
forwarded to
BriefCase-
Quantification | |
| - For each CT study
received, the
software shall
validate there is at
least one compliant
series in which the
entire heart is
present, and
perform an
analysis. | - The device uses a
deep learning-
based computer
vision algorithm for
its assessment. | - 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 evaluation of
CAC. | |
Table 1. Key feature comparison
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Image /page/6/Picture/0 description: The image shows the logo for Aidoc. The logo is in a sans-serif font and is a dark blue color. There is a small orange dot to the right of the 'c' in Aidoc.
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Image /page/7/Picture/0 description: The image shows the logo for "aidoc.". The logo is in a sans-serif font and is a dark blue color, except for the period at the end, which is orange. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the logo for "AIdoc". The logo is written in a sans-serif font, with the letters in blue. The dot on the end of the word is orange. The logo is simple and modern.
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 estimated coronary artery calcification detection category from non-cardiac-gated NCCT images that include the heart in 433 cases from 6 US-based clinical sites, both academic and community centers, compared to the ground truth. In cases where the reviewers disagree on the level of CAC, the senior US board-certified radiologist provided a final opinion which has established the ground truth. The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm.
Primary Endpoint
The algorithm performance showed that the overall agreement between the ground truth and algorithm across estimated CAC scores was 87.1%. Because the overall agreement estimate was up to the prespecified performance goal, the study's primary endpoint was achieved.
Secondary Endpoint
The algorithm performance between the ground truth and algorithm, in individual categories, was as follows: very low = 95.1%; low = 81.3%; medium = 81.5%; and high =89.3% . Because the overall agreement estimate was up to the prespecified performance goal across all individual categories, the study's secondary endpoint was achieved.
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Image /page/9/Picture/0 description: The image shows the logo for "aidoc". The logo is written in a sans-serif font, and the letters are blue. There is a small orange circle to the right of the "c" in "aidoc". The logo is simple and modern.
Thus, the reported similar overall agreement for subject, predicate and reference devices demonstrates that when using the subject BriefCase-Quantification for Coronary Artery Calcification (CAC) the appropriately trained medical specialists may have the same benefits as when using the HealthCCSng and iCAC.
As can be seen in Table 2 the mean age of patients whose scans were reviewed for BriefCase-Quantification for Coronary Artery Calcification (CAC) was 67.4 years, with a standard deviation of 12.8 years. Gender distribution was 50% male, and 50% female (Table 3). Scanner distribution can also be found in Table 4 below.
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age | ||||||
| (Years) | 67.4 | 12.8 | 30 | 69 | 90 | 432* |
Table 2. Descriptive Statistics for Age
- 1 case did not have any age information in the DICOM metadata
| Table 3. Frequency Distribution of Gender | |||
|---|---|---|---|
| ------------------------------------------- | -- | -- | -- |
| Ground | Gender | |||||
|---|---|---|---|---|---|---|
| Truth | ||||||
| Results | Female | Male | All | |||
| N | % | N | % | N | % | |
| Very | ||||||
| Low | 64 | 62% | 39 | 38% | 103 | 100% |
| Low | 50 | 47% | 57 | 53% | 107 | 100% |
| Medium | 47 | 51% | 45 | 49% | 92 | 100% |
| High | 54 | 41% | 77 | 59% | 131 | 100% |
| All | 215 | 50% | 218 | 50% | 433 | 100% |
Table 4. Frequency Distribution of Manufacturer
| Manufacturer | Very Low | Low | Medium | High | All |
|---|---|---|---|---|---|
| GE | 30 (25%) | 27 (23%) | 29 (24%) | 33 (28%) | 119 (100%) |
| Philips | 20 (18%) | 36 (33%) | 28 (25%) | 26 (24%) | 110 (100%) |
10
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| Manufacturer | Very Low | Low | Medium | High | All |
|---|---|---|---|---|---|
| Siemens | 12 (23%) | 13 (25%) | 6 (12%) | 21 (40%) | 52 (100%) |
| Toshiba | 41 (27%) | 31 (20%) | 29 (19%) | 51 (34%) | 152 (100%) |
| Total | 103 (24%) | 107 (25%) | 92 (21%) | 131 (30%) | 433 (100%) |
Clinical Subgroups and Confounders: Fully negative; Inflammatory; Neoplastic; Heart and Vascular; Trauma, Chronic diseases and None of the above.
In summary, performance validation data, combined with a comparison of overall agreement metric with the reference device demonstrated equivalent performance.
Conclusions
The subject BriefCase-Quantification for Coronary Artery Calcification (CAC), the predicate HealthCCSng and the reference iCAC are software devices intended to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. 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 Al algorithms that process images. In all devices, the labeling instructs the results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CT studies.
The subject, predicate and reference devices operate in parallel to the standard of care workflow in the sense that they have the potential to allow accurate evaluation and facilitate the standard manual workflow. The BriefCase-Quantification for Coronary Artery Calcification (CAC) device is thus substantially equivalent and as safe and effective to the HealthCCSng and iCAC devices.