Who is the manufacturer of BriefCase-Quantification?

Aidoc Medical , Ltd. filed the 510(k) submission for BriefCase-Quantification (K242203).

What is the FDA product code for BriefCase-Quantification?

QIH. It is classified under 21 CFR 892.2050 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 (K242203) 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

Q: What are the predicate devices for BriefCase-Quantification?

BriefCase-Quantification of M-AbdAo (K241112).

K242203 · Aidoc Medical , Ltd. · QIH · Nov 22, 2024 · Radiology

Device Facts

Record ID	K242203
Device Name	BriefCase-Quantification
Applicant	Aidoc Medical , Ltd.
Product Code	QIH · Radiology
Decision Date	Nov 22, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older. BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas. The device provides the following assessments: - Aortic measurements at 10 anatomical landmarks; - Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Device Story

BriefCase-Quantification is a cloud-hosted radiological image management and processing software. It receives filtered DICOM contrast-enhanced CT images as input. Using a deep-learning AI algorithm, it automatically processes images to measure aortic diameters at 10 anatomical landmarks and identifies the maximum aortic diameter for the abdominal, descending, and ascending aorta. The output is exported in DICOM format to a PACS and displayed in a desktop image review application. The device is operated by hospital networks and trained medical specialists. The output serves as an unofficial, non-final visualization aid; clinicians must review the full original images per standard of care. The device does not replace clinical assessment or diagnostic decision-making, but assists in quantifying aortic dimensions to facilitate standard workflows and potentially improve measurement accuracy.

Clinical Evidence

Retrospective, blinded, multicenter study of 212 contrast-enhanced CT cases from 6 US sites. Compared algorithm measurements against ground truth established by three board-certified radiologists. Primary endpoint: mean absolute error (MAE) across 10 landmarks. Results: MAE of 1.88 mm (95% CI: 1.78 mm, 1.99 mm), meeting the performance goal. Secondary endpoint: Bland-Altman analysis showed a mean difference of 0.1 mm, indicating minimal bias. Study population mean age 63.2 years; gender distribution 49.8% male/50.2% female.

Technological Characteristics

Radiological image management and processing software. Utilizes deep-learning AI algorithms. Operates on a Linux-based server in a cloud environment. Inputs: DICOM contrast-enhanced CT images. Outputs: DICOM images and tabular measurements. Connectivity: Integrated with PACS and desktop review applications. No specific material standards or energy sources applicable as it is software-only.

Indications for Use

Indicated for adults and transitional adolescents aged 18+ undergoing contrast-enhanced CT exams of the aorta. Used to evaluate normal and aneurysmal aortas. Contraindicated for post-operative aortas.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

BriefCase-Quantification of M-AbdAo (K241112)

Reference Devices

Al-Rad Companion (Cardiovascular) (K222360)

Related Devices

K230534 — BriefCase-Quantification · Aidoc Medical , Ltd. · Nov 8, 2023
K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ) · BunkerHill Health · Jul 1, 2025
K241112 — BriefCase-Quantification · Aidoc Medical , Ltd. · May 15, 2024
K222360 — AI-Rad Companion (Cardiovascular) · Siemens Medical Solutions U.S.A. · Apr 6, 2023
K183268 — AI-Rad Companion (Cardiovascular) · Siemens Medical Solutions USA, Inc. · Sep 10, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004 November 22,2024 Re: K242203 Trade/Device Name: BriefCase-Quantification Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: July 26, 2024 Received: October 22, 2024 Dear John Smith: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K242203 Device Name BriefCase-Quantification #### Indications for Use (Describe) BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older. BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas. The device provides the following assessments: - · Aortic measurements at 10 anatomical landmarks; - · Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Aidoc. The logo is in blue, except for a small orange dot at the end. The logo is simple and modern. ## 510(k) Summary ## Aidoc Medical, Ltd.'s BriefCase-Quantification ### Submitter: | Aidoc Medical, Ltd. | | |---------------------------|------------------------------------------------| | 3 Aminadav St. | | | Tel-Aviv, Israel | | | Phone: +972-73-7946870 | | | Contact Person: | Amalia Schreier, LL.M. | | Date Prepared: | November 21, 2024 | | Name of Device: | BriefCase-Quantification | | Classification Name: | Medical image management and processing system | | Regulatory Class: | Class II | | Product Code: | QIH (21 C.F.R. 892.2050) | | Primary Predicate Device: | BriefCase-Quantification of M-AbdAo (K241112) | Reference Device:Al-Rad Companion (Cardiovascular) (K222360) ## Device Description BriefCase-Quantification is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment. The BriefCase-Quantification receives filtered DICOM Images, and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (desktop application), and forwarded to user review in the PACS. The BriefCase-Quantification produces images and tabular views of the landmarks and segments selected per installation to be displayed in the image review software, provided by the Image Communication Platform integrated with Briefcase-Quantification. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist." BriefCase-Quantification is not intended to evaluate post-operative aortas. {5}------------------------------------------------ #### Intended Use / Indications for Use BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older. BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas. The device provides the following assessments: - . Aortic measurements at 10 anatomical landmarks; - Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. ● The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care. ### Comparison of Technological Characteristics The subject BriefCase-Quantification of Aortic Measurement (M-Aorta) is substantially similar to primary predicate BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) (K241112) and is similar to the reference device Al-Rad Companion (Cardiovascular) (K222360), as explained below. All three devices are radiological computer-aided medical image management and processing software. All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners. PACS, and radiology workstations. The primary predicate BriefCase-Quantification of M-AbdAo and the reference Al-Rad Companion (Cardiovascular) evaluate images from CT scanners as does the proposed device for BriefCase-Quantification of Aortic Measurement (M-Aorta). The devices produce similar outputs that include a diameter measurement image series of certain segments of the aorta (abdominal, ascending and descending aorta; abdominal aorta; ascending and descending aorta - respectively). The proposed device for BriefCase-Quantification of Aortic Measurement (M-Aorta) has similar technology and design as the primary predicate device and the reference device, and similar indications for use, i.e., all three devices are intended to aid in measurement of the aorta in radiological images. The subject, the predicate BriefCase-Quantification of M-AbdAo and the reference Al-Rad Companion (Cardiovascular) devices raise the same types of safety and effectiveness questions. A table comparing the key features of the subject device, the primary predicate device and the reference predicate device is provided below. {6}------------------------------------------------ ## Table 1. Key feature comparison | | Predicate Device BriefCase- Quantification of the Abdominal Aortic Measurement (M-AbdAo) (K241112) | Reference Device Al-Rad Companion (Cardiovascular) (K222360) | Subject Device Aidoc BriefCase- Quantification of Aortic Measurement (M-Aorta) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for Use | BriefCase- Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter of cases that includes the abdominal aorta (M- AbdAo). BriefCase- Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas. The BriefCase- Quantification results are not intended to be | Al-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: - Segmentation and volume measurement of the heart - Quantification of the total calcium volume in the coronary arteries - Segmentation of the aorta - Measurement of maximum diameters of the aorta at typical landmarks | BriefCase- Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older. BriefCase- Quantification of Aortic Measurement (M- Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase- Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post- operative aortas. | | Predicate Device BriefCase- Quantification of the Abdominal Aortic Measurement (M- AbdAo) (K241112) | Reference Device Al- Rad Companion (Cardiovascular) (K222360) | Subject Device Aidoc BriefCase- Quantification of Aortic Measurement (M-Aorta) | | | used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care. | Threshold-based highlighting of enlarged diameters The software has been validated for non- cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non- cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM images of adult patients are considered to be valid input. | The device provides the following assessmnets: ● Aortic measurements at 10 anatomical landmarks; ● Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. The BriefCase- Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing | | | | Predicate Device BriefCase- Quantification of the Abdominal Aortic Measurement (M- AbdAo) (K241112) | Reference Device Al- Rad Companion (Cardiovascular) (K222360) | Subject Device Aidoc BriefCase- Quantification of Aortic Measurement (M-Aorta) | | | | | full images per the standard of care. | | User population | Appropriately trained medical specialists | Radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice | Hospital networks and appropriately trained medical specialists | | Anatomical region of interest | Abdominal aorta | Heart, coronary arteries and aorta | Aorta | | Data acquisition protocol | CT exams with contrast that include the abdominal aorta | non-cardiac chest CT | contrast-enhanced CT exams that include the aorta | | Diameter Measurement | Yes | Yes | Yes | | Images format | DICOM | DICOM | DICOM | | Interference with standard workflow | No | No | No | | Algorithm | Artificial intelligence algorithm with database of images. | Artificial intelligence algorithm with database of images. | Artificial intelligence algorithm with database of images. | | Structure | -BriefCase- Quantification, is hostedon a cloud server, analyzes applicable CT images that are acquired on CT scanner that are forwarded to BriefCase- Quantification. | - The system remains hosted in the teamplay digital health platform and remains driven by the Al-Rad Companion Engine. - The edge deployment the processing of clinical | - BriefCase- Quantification is hosted on a cloud server, analyzes applicable CT images that are forwarded to BriefCase- Quantification. - The results of the analysis are exported | | Predicate Device BriefCase- Quantification of the Abdominal Aortic Measurement (M- AbdAo) (K241112) | Reference Device Al- Rad Companion (Cardiovascular) (K222360) | Subject Device Aidoc BriefCase- Quantification of Aortic Measurement (M-Aorta) | | | - The results of the analysis are exported in DICOM format, and are sent to a PACS destination for review by medical specialists, to assist in the measurement of the abdominal aorta. | data and the generation of results are performed within the customer environment. - This system remains fully connected to the cloud for monitoring and maintenance of the system from a remote setup. | in DICOM format, and are sent to a PACS destination for review by medical specialists, to assist in the measurement of the abdominal aorta. | | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### Performance Data #### Pivotal Study Summary Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Quantification software to evaluate the software's performance in providing quantitative diameter measurements across a set of 10 aorta landmarks and measurements of the maximum aortic diameter at three segments abdominal ascending, and descending in contrast-enhanced CT exams that include the aorta in 212 cases, from 6 US-based clinical sites, both academic and community centers, compared to the ground truth, as determined by three US board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm. #### Primary Endpoint The algorithm performance showed that the mean absolute error between the ground truth measurement and algorithm across all landmarks and across all studies was 1.88 mm (95% Cl: 1.78 mm, 1.99 mm). Because the mean absolute error estimate was below the prespecified performance goal, the study's primary endpoint was achieved. The reported similar mean absolute error [the subject device: 1.88 mm (95% Cl: 1.78 mm, 1.99 mm); the predicate device: 1.95 mm (95% Cl: 1.59 mm, 2.32 mm)] demonstrates comparable performance. As can be seen in Table 2, the mean age of patients whose scans were reviewed for BriefCase-Quantification of Aortic Measurement (M-Aorta) was 63.2 years, with a standard deviation of 19.3 years. Gender distribution was 49.8% male, and 50.2% female (Table 3). Scanner distribution can also be found in Table 4 below. {10}------------------------------------------------ | | Mean | Std | Min | Median | Max | N | |----------------|------|------|------|--------|------|-----| | Age (Years) | 63.0 | 19.3 | 18.0 | 67.0 | 90.0 | 212 | Table 2. Descriptive Statistics for Age #### Table 3. Frequency Distribution of Gender | Gender | N* | % | |--------|-----|-----| | Male | 106 | 50% | | Female | 106 | 50% | #### Table 4. Frequency Distribution of Manufacturer | Manufacturer | N | % | |--------------|-----|-------| | Siemens | 58 | 27.4% | | GE | 49 | 23.1% | | Philips | 50 | 23.6% | | Toshiba | 55 | 25.9% | | Total | 212 | 100% | Clinical Subgroups and Confounders: Aortic Aneurysm; Vasculitis, penetrating atherosclerotic ulcer, and mural thrombus; Aortic calcification/atherosclerosis; Aortic dissection; Retroperitoneal lymphadenopathy / enlarged para-aortic nodes and None of the above. Performance testing results for the Bland-Altman analysis is reported below: The mean difference between the ground truth compared to the algorithm output is 0.1 mm, indicating that there is little to no bias between the two measurements, demonstrating the study's secondary endpoint was achieved. In summary, performance validation data, combined with a comparison of mean absolute error metric with the primary predicate device demonstrated equivalent performance. #### Conclusions The subject BriefCase-Quantification of Aortic Measurement (M-Aorta), the primary predicate BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) and the reference device {11}------------------------------------------------ Al-Rad Companion (Cardiovascular) are intended to aid in medical image management and processing of radiological images in CT. The devices are not intended to be used as diagnostic devices. All three devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning AI algorithms that process images. They additionally operate in parallel to the standard of care workflow in the sense that they have the potential to allow accurate measurement and facilitate the standard manual workflow. In all devices, the labeling instructs the user that the results are not intended to be used on a standalone basis for clinical decision making or otherwise preclude clinical assessment. The subject and predicate device have similar clinications and show substantially similar performance. The BriefCase-Quantification of Aortic Measurement (M-Aorta) device demonstrates substantial equivalence to the BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) and Al-Rad Companion (Cardiovascular).