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 Description

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

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

The BriefCase-Quantification produces 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving device performance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Metric / Acceptance Criteria	Reported Device Performance
Primary Endpoint: Mean Absolute Error (MAE) between ground truth measurement and algorithm across all landmarks and studies.	1.88 mm (95% CI: 1.78 mm, 1.99 mm). (This was "below the prespecified performance goal," thus achieving the primary endpoint. The reported MAE of the subject device (1.88 mm) was comparable to the predicate device [1.95 mm (95% CI: 1.59 mm, 2.32 mm)].)
Secondary Endpoint: Bias between ground truth and algorithm output (Mean Difference in Bland-Altman analysis).	0.1 mm (This indicates "little to no bias between the two measurements," demonstrating the study's secondary endpoint was achieved.)

2. Sample Size and Data Provenance

Test Set Sample Size: 212 cases
Data Provenance: Retrospective, multicenter study. Cases were collected from 6 US-based clinical sites, including both academic and community centers. The cases were distinct in time and/or center from those used to train the algorithm.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three (3)
Qualifications: US board-certified radiologists.

4. Adjudication Method for the Test Set

The document states the ground truth was "determined by three US board-certified radiologists." While it doesn't explicitly detail a 2+1 or 3+1 method, the implication of "determined by" three experts suggests a consensus-based approach, likely one where all three agreed or a majority agreement was required for the final ground truth. It does not mention any specific adjudication process explicitly (e.g., if disagreements were resolved by a fourth reader).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The study described is a standalone (algorithm-only) performance evaluation against expert-established ground truth. It does not compare human readers with and without AI assistance.
Effect size of improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm-Only) Performance

Was a standalone performance study done? Yes. The "Pivotal Study Summary" describes the evaluation of "the software's performance ... compared to the ground truth," focusing on the algorithm's accuracy in measurement against expert consensus.

7. Type of Ground Truth Used

Type of Ground Truth: Expert consensus. Specifically, the ground truth was "determined by three US board-certified radiologists."

8. Sample Size for the Training Set

The document explicitly states: "The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm." However, the exact sample size for the training set is not provided in the given text.

9. How the Ground Truth for the Training Set was Established

The document does not detail how the ground truth for the training set was established. It only mentions that the training cases were distinct from the test set cases.

Summary

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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.

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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

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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

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Indications for Use

Submission Number (if known)

K242203

Device Name

BriefCase-Quantification

Indications for Use (Describe)

The device provides the following assessments:

· Aortic measurements at 10 anatomical landmarks;
· Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta.

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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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

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.

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

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Intended Use / Indications for Use

The device provides the following assessments:

. Aortic measurements at 10 anatomical landmarks;
Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta. ●

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.

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Table 1. Key feature comparison

	Predicate DeviceBriefCase-Quantification of theAbdominal AorticMeasurement (M-AbdAo) (K241112)	Reference Device Al-Rad Companion(Cardiovascular)(K222360)	Subject DeviceAidoc BriefCase-Quantification ofAortic Measurement(M-Aorta)
Intended Use /Indications for Use	BriefCase-Quantification is aradiological imagemanagement andprocessing systemsoftware indicated foruse in the analysis ofCT exams withcontrast, that includethe abdominal aorta, inadults or transitionaladolescents aged 18and older.The device is intendedto assist appropriatelytrained medicalspecialists byproviding the user withthe maximumabdominal aortic axialdiameter of cases thatincludes theabdominal aorta (M-AbdAo). BriefCase-Quantification isindicated to evaluatenormal andaneurysmal abdominalaortas and is notintended to evaluatepost-operative aortas.The BriefCase-Quantification resultsare not intended to be	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 volume inthe coronary arteries- Segmentation of theaorta- Measurement ofmaximum diameters ofthe aorta at typicallandmarks	BriefCase-Quantification is aradiological imagemanagement andprocessing systemsoftware indicated foruse in the analysis ofcontrast-enhanced CTexams that include theaorta in adults ortransitionaladolescents aged 18and older.BriefCase-Quantification of AorticMeasurement (M-Aorta) is intended toassist hospitalnetworks andappropriately trainedmedical specialists byproviding the user withaortic diametermeasurements acrossthe aorta. BriefCase-Quantification isindicated to evaluatenormal andaneurysmal aortas andis not intended toevaluate post-operative aortas.
Predicate DeviceBriefCase-Quantification of theAbdominal AorticMeasurement (M-AbdAo) (K241112)	Reference Device Al-Rad Companion(Cardiovascular)(K222360)	Subject DeviceAidoc BriefCase-Quantification ofAortic Measurement(M-Aorta)
used on a stand-alonebasis for clinicaldecision-making orotherwise precludeclinical assessment ofcases.These measurementsare unofficial, are notfinal, and are subject tochange after review bya radiologist. For finalclinically approvedmeasurements, pleaserefer to the officialradiology report.Clinicians areresponsible for viewingfull images per thestandard of care.	Threshold-basedhighlighting ofenlarged diametersThe software has beenvalidated for non-cardiac chest CT datawith filteredbackprojectionreconstruction fromSiemens Healthineers,GE Healthcare,Philips, andToshiba/Canon.Additionally, thecalcium detectionfeature has beenvalidated on non-cardiac chest CT datawith iterativereconstruction fromSiemens Healthineers.Only DICOM imagesof adult patients areconsidered to be validinput.	The device providesthe followingassessmnets:● Aorticmeasurements at 10anatomical landmarks;● Maximumaortic diameter ofthe abdominalaorta, descendingaorta andascending aorta.The BriefCase-Quantification resultsare not intended to beused on a stand-alonebasis for clinicaldecision-making orotherwise precludeclinical assessment ofcases.These measurementsare unofficial, are notfinal, and are subject tochange after review bya radiologist. For finalclinically approvedmeasurements, pleaserefer to the officialradiology report.Clinicians areresponsible for viewing
	Predicate DeviceBriefCase-Quantification of theAbdominal AorticMeasurement (M-AbdAo) (K241112)	Reference Device Al-Rad Companion(Cardiovascular)(K222360)	Subject DeviceAidoc BriefCase-Quantification ofAortic Measurement(M-Aorta)
			full images per thestandard of care.
User population	Appropriately trainedmedical specialists	Radiologists andphysicians fromemergency medicine,specialty care, urgentcare, and generalpractice	Hospital networks andappropriately trainedmedical specialists
Anatomical region ofinterest	Abdominal aorta	Heart, coronaryarteries and aorta	Aorta
Data acquisitionprotocol	CT exams withcontrast that includethe abdominal aorta	non-cardiac chest CT	contrast-enhanced CTexams that include theaorta
DiameterMeasurement	Yes	Yes	Yes
Imagesformat	DICOM	DICOM	DICOM
Interference withstandard workflow	No	No	No
Algorithm	Artificial intelligencealgorithm withdatabase of images.	Artificial intelligencealgorithm withdatabase of images.	Artificial intelligencealgorithm withdatabase of images.
Structure	-BriefCase-Quantification,is hostedon a cloudserver, analyzesapplicable CT imagesthat are acquired onCT scanner that areforwarded toBriefCase-Quantification.	- The system remainshosted in the teamplaydigital health platformand remains driven bythe Al-Rad CompanionEngine.- The edgedeployment theprocessing of clinical	- BriefCase-Quantification ishosted on a cloudserver, analyzesapplicable CT imagesthat are forwarded toBriefCase-Quantification.- The results of theanalysis are exported
Predicate DeviceBriefCase-Quantification of theAbdominal AorticMeasurement (M-AbdAo) (K241112)	Reference Device Al-Rad Companion(Cardiovascular)(K222360)	Subject DeviceAidoc BriefCase-Quantification ofAortic Measurement(M-Aorta)
- The results of theanalysis are exportedin DICOM format, andare sent to a PACSdestination for reviewby medical specialists,to assist in themeasurement of theabdominal aorta.	data and thegeneration ofresults are performedwithin the customerenvironment.- This system remainsfully connected to thecloud for monitoringand maintenance ofthe system from aremote setup.	in 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 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.

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	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

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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).

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).