BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older.

The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement of cases that include the abdominal aorta (M-AbdAo), BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate postoperative aortas.

The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Device Description

BriefCase-Quantification is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.

The BriefCase-Quantification receives filtered DICOM Images, and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (desktop application), and forwarded to user review in the PACS.

The BriefCase-Quantification produces a preview image annotated with the maximum axial diameter measurement. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist."

BriefCase-Quantification is not intended to evaluate post-operative aortas.

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mean absolute error between ground truth measurement and algorithm	1.95 mm (95% Cl: 1.59 mm, 2.32 mm)
Performance Goal	Mean absolute error estimate below prespecified performance goal (specific numerical goal not explicitly stated, but was met)

2. Sample size used for the test set and the data provenance

Test set sample size: 160 cases
Data provenance: Retrospective, from 6 US-based clinical sites (both academic and community centers). The cases were distinct in time and/or center from the training data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: 3
Qualifications of experts: US board-certified radiologists.

4. Adjudication method for the test set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1). It only mentions that the ground truth was "determined by three US board-certified radiologists." This implies a consensus-based approach, but the specific decision rule is not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance versus without AI assistance was not done. This study focused on the standalone performance of the algorithm against a ground truth established by experts.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study of the algorithm was done. The "Primary Endpoint" section details the algorithm's performance (mean absolute error) compared to the ground truth.

7. The type of ground truth used

Expert consensus was used as the ground truth. The ground truth measurements were "determined by three US board-certified radiologists."

8. The sample size for the training set

The document does not specify the sample size for the training set. It only states that the cases collected for the pivotal dataset (test set) were "distinct in time and/or center from the cases used to train the algorithm."

9. How the ground truth for the training set was established

The document does not explicitly describe how the ground truth for the training set was established. It only mentions that the cases were "distinct in time and/or center from the cases used to train the algorithm," implying that training data also had a ground truth, likely established by similar expert review, but this is not detailed.

Summary

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Aidoc Medical, Ltd. % John Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

November 8, 2023

Re: K230534

Trade/Device Name: BriefCase-Quantification Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: October 3, 2023 Received: October 3, 2023

Dear John Smith:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230534

Device Name BriefCase-Quantification

Indications for Use (Describe)

Brief Case-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K230534

510(k) Summarv K230534 Aidoc Medical, Ltd.'s BriefCase-Quantification

Submitter:

Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
Phone: +972-73-7946870

Contact Person:	Amalia Schreier, LL.M.
Date Prepared:	November 05, 2023
Name of Device:	BriefCase-Quantification
Classification Name:	Medical image management and processing system
Regulatory Class:	Class II
Product Code:	QIH (21 C.F.R. 892.2050)
Primary Predicate Device:	Viz RV/LV (K221100)
Reference Device:	Al-Rad Companion (Cardiovascular) (K183268)

Device Description

BriefCase-Quantification is not intended to evaluate post-operative aortas.

Intended Use / Indications for Use

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The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement of cases that include the abdominal aorta (M-AbdAo) BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.

Comparison of Technological Characteristics

The subject BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) is substantially similar to primary predicate Viz RV/LV (K221100) and is similar to reference device Al-Rad Companion (Cardiovascular) (K183268), as explained below.

The subject, predicate and the reference devices are radiological computer-aided medical image management and processing software. All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners. PACS, and radiology workstations. The predicate Viz RV/LV and the reference Al-Rad Companion (Cardiovascular) evaluate images from CT scanners as does the proposed device for BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo). The subject, predicate and reference devices produce similar outputs that includes a diameter measurement of an anatomical organ image series (Abdominal aorta; Left and right ventricles of the heart; aorta - respectively).

The proposed device for BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) has similar technology and design as the primary predicate device and the reference device, and similar indications for use, i.e., all three devices are intended to aid in measurement of radiological images. The subject, the predicate Viz RV/LV and the reference Al-Rad Companion (Cardiovascular) devices raise the same types of safety and effectiveness questions. A table comparing the key features of the subject device, the primary predicate device and the reference predicate device is provided below.

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	Predicate Device VizRV/LV (K221100)	Reference DeviceAl-Rad Companion(Cardiovascular)(K183268)	Subject DeviceAidocBriefCase-Quantification of theAbdominal AorticMeasurement(M-AbdAo)
Intended Use /Indications for Use	The Viz RV/LVSoftware device isdesigned to measurethe maximaldiameters of the rightand left ventricles ofthe heart from avolumetric CTPAacquisition and reportthe ratio of thosemeasurements. VizRV/LV analyzes casesusing an artificialintelligence algorithmto identify the locationand measurements ofthe ventricles. The VizRV/LV softwareprovides the user withannotated imagesshowing ventricularmeasurements. Itsresults are notintended to be usedon a stand-alonebasis for clinicaldecision-making orotherwise precludeclinical assessment ofCTPA cases.	Al-Rad Companion(Cardiovascular) isimage processingsoftware that providesquantitative andqualitative analysisfrom previouslyacquired ComputedTomography DICOMimages to supportradiologists andphysicians fromemergency medicine,specialty care, urgentcare, and generalpractice in theevaluation andassessment ofcardiovasculardiseases.It provides thefollowing functionality:• Segmentation andvolume measurementof the heart• Quantification of thetotal calcium volumein the coronaryarteries• Segmentation of theaorta• Measurement ofmaximum diametersof the aorta at typicallandmarks	BriefCase-Quantification is a radiologicalimage managementand processingsystem softwareindicated for use inthe analysis of CTexams with contrast,that include theabdominal aorta, inadults or transitionaladolescents aged 18and older.The device isintended to assistappropriately trainedmedical specialists byproviding the userwith the maximumabdominal aortic axialdiameter of cases thatincludes theabdominal aorta(M-AbdAo).BriefCase-Quantification is indicated toevaluate normal andaneurysmalabdominal aortas andis not intended toevaluatepost-operative aortas.TheBriefCase-Quantification results are not
	Predicate Device Viz RV/LV (K221100)	Reference Device Al-Rad Companion (Cardiovascular) (K183268)	Subject Device Aidoc BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo)
		Threshold-based highlighting of enlarged diameters The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers.Only DICOM images of adult patients are considered to be valid input.	intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.
User population	Thoracic radiologists, general radiologists, pulmonologists, cardiologists, or other similar physicians	Radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice	Appropriately trained medical specialists
Anatomical region of interest	Left and right ventricles of the heart	Heart, coronary arteries and aorta	Abdominal aorta
	Predicate Device VizRV/LV (K221100)	Reference DeviceAl-Rad Companion(Cardiovascular)(K183268)	Subject DeviceAidocBriefCase-Quantification of theAbdominal AorticMeasurement(M-AbdAo)
Data acquisitionprotocol	non-gated CTPA	non-cardiac chest CT	CT exams with contrast that include the abdominal aorta
DiameterMeasurement	Yes	Yes	Yes
Imagesformat	DICOM	DICOM	DICOM
Interference withstandard workflow	No	No	No
Algorithm	Artificial intelligence algorithm withdatabase of images.	Artificial intelligence algorithm withdatabase of images.	Artificial intelligence algorithm withdatabase of images.
Structure	- Viz RV/LV is hostedon Viz.ai's BackendServer and analyzesapplicable CTPAscans.- The results areexported in DICOMformat are sent to aPACS destination forreview by physiciansto assist in theassessment.	- Al-Rad Companion(Cardiovascular) is asoftware only imagepost-processingapplication.	-BriefCase-Quantification, is hosted on acloud server, analyzesapplicable CT imagesthat are acquired onCT scanner that areforwarded toBriefCase-Quantification.- The results of theanalysis are exportedin DICOM format, andare sent to a PACSdestination for reviewby medical specialists,to assist in themeasurement of theabdominal aorta

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Performance Data

Pivotal Study Summary

Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Quantification software to evaluate the software's performance in providing maximum axial diameter measurements of the abdominal aorta in CT images in 160 cases, from 6 US-based clinical sites, both academic and community centers, compared to the ground truth, as determined by three US

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board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm.

Primary Endpoint

The algorithm performance showed that the mean absolute error between the ground truth measurement and algorithm was 1.95 mm (95% Cl: 1.59 mm, 2.32 mm). Because the mean absolute error estimate was below the prespecified performance goal, the study's primary endpoint was achieved.

The reported similar mean absolute error [the subject device: 1.95 mm (95% C1: 1.59 mm, 2.32 mm); the reference device: 1.6 mm (95% Cl: 1.5 mm, 1.7 mm)] demonstrates comparable performance.

As can be seen in Table 2, the mean age of patients whose scans were reviewed for BriefCase-Quantification of the Abdominal Aortic Measurement was 66.8 years, with a standard deviation of 14.8 years. Gender distribution was 58.8% male, and 40.0% female (Table 3). Scanner distribution can also be found in Table 4 below.

	Mean	Std	Min	Median	Max	N
Age(Years)	66.8	14.8	25	69	90	160

Table 2. Descriptive Statistics for Age

Table 3. Frequency Distribution of Gender

Gender	N*	%
Male	94	58.8%
Female	64	40.0%

2 cases had unknown gender defined in the DICOM metadata header and were excluded from the gender distribution

Table 4. Frequency Distribution of Manufacturer

Manufacturer	N	%
Siemens	52	32.5%
GE	46	28.8%
Philips	39	24.4%
Toshiba	23	14.4%
Total	160	100%

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Clinical Subgroups and Confounders: Inflammatory; Neoplasm; Trauma; Abdominal Pathologies; Urinary system pathologies and None of the above.

Additional descriptive statistics and Bland Altman analysis were also reported in the labeling.

In summary, performance validation data, combined with a comparison of mean absolute error metric with the reference device demonstrated equivalent performance.

Conclusions

The subject BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo), the predicate Viz RV/LV and the reference device Al-Rad Companion (Cardiovascular) are intended to aid in medical image management and processing of radiological images in CT. The subject, predicate and the reference devices are not intended to be used as diagnostic devices. All three devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning AI algorithms that process images. They additionally operate in parallel to the standard of care workflow in the sense that they have the potential to allow accurate measurement and facilitate the standard manual workflow.

In both devices, the labeling instructs the user that the results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment. The subject and reference device have similar clinical indications and show substantially similar performance.

The BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) device is thus substantially equivalent and is as safe and effective to the Viz RV/LV and Al-Rad Companion (Cardiovascular).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).