Who is the manufacturer of BriefCase-Quantification?

Aidoc Medical , Ltd. filed the 510(k) submission for BriefCase-Quantification (K231631).

What is the FDA product code for BriefCase-Quantification?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for BriefCase-Quantification?

510(k) clearance (submission type: Traditional).

Does BriefCase-Quantification use AI or machine learning?

Yes. BriefCase-Quantification (K231631) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like BriefCase-Quantification?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like BriefCase-Quantification get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

BriefCase-Quantification

K231631 · Aidoc Medical , Ltd. · JAK · Nov 28, 2023 · Radiology

Device Facts

Record ID	K231631
Device Name	BriefCase-Quantification
Applicant	Aidoc Medical , Ltd.
Product Code	JAK · Radiology
Decision Date	Nov 28, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended 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.

Device Story

BriefCase-Quantification is a standalone software as a medical device (SaMD) operating on a Linux-based cloud server. It receives non-gated, non-contrast CT scans; uses a deep-learning AI algorithm to detect and quantify calcified plaques in coronary arteries; and outputs a four-category classification (very low, low, medium, high) corresponding to Agatston score ranges. The device provides preview axial images of detected calcium to the PACS or desktop application. It is used by hospital networks and medical specialists as an adjunct to standard clinical workflows. The output is informational; clinicians must review full images and clinical data before making decisions. The device aims to assist in the evaluation of coronary artery disease risk.

Clinical Evidence

Retrospective, blinded, multicenter study of 433 cases from 6 US clinical sites. Primary endpoint: overall agreement between algorithm and ground truth (established by senior board-certified radiologist) was 87.1%. Secondary endpoints (agreement by category): very low (95.1%), low (81.3%), medium (81.5%), and high (89.3%). Study population mean age 67.4 years; gender distribution 50% male/50% female. Results demonstrate performance comparable to reference devices.

Technological Characteristics

Standalone software; Linux-based server in cloud environment. Uses deep-learning AI algorithm for image analysis. Compatible with standard CT scanners, PACS, and radiology workstations. Processes non-cardiac-gated NCCT images (slice thickness up to 5.0 mm). Default calcium threshold: 130 HU. Outputs four-category CAC classification and preview axial images.

Indications for Use

Indicated for adult patients aged 30 and older undergoing non-cardiac-gated non-contrast CT (NCCT) imaging that includes the heart. Used to assist physicians in identifying coronary artery calcification (CAC) plaques.

Regulatory Classification

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.

Predicate Devices

HealthCCSng (K210085)

Reference Devices

iCAC (K230223)

Related Devices

K240369 — CAC (gated) Algorithm · BunkerHill Health · Sep 27, 2024
K230112 — CAC Software · Imbio, Inc. · Jun 13, 2023
K260166 — Bunkerhill Contrast CAC · BunkerHill Health · Mar 6, 2026
K230223 — iCAC Device · Bunkerhill, Inc. · Apr 25, 2023
K241440 — HealthCCSng · Nano-X AI , Ltd. · Aug 19, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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). {1}------------------------------------------------ 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) K231631 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {3}------------------------------------------------ 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. {5}------------------------------------------------ | | 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 {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 Gen…