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 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.

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.

BriefCase-Quantification produces a preview image annotated with the maximum 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 measurement which is not final, 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 a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Performance Goal)	Reported Device Performance
Mean Absolute Error (MAE) between ground truth and algorithm measurement below a prespecified goal.	1.52 mm (95% Cl: 1.20 mm, 1.83 mm)
Little to no bias between ground truth and algorithm output.	Mean difference of 0.58 mm

Study Details

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

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

Sample Size (Test Set): 162 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: Three (3)
Qualifications: US board-certified radiologists

4. Adjudication method for the test set:
The text states the ground truth was "as determined by three US board-certified radiologists." It doesn't explicitly specify an adjudication method like 2+1 or 3+1, but implies a consensus or agreement among the three experts formed the ground truth.

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 of human readers with and without AI assistance was not conducted. The study focused on the standalone performance of the algorithm against a human-established ground truth.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study of the algorithm's performance was done. The study evaluated the BriefCase-Quantification software's performance in providing maximum diameter measurements compared to a ground truth established by radiologists.

7. The type of ground truth used:
Expert consensus among three US board-certified radiologists.

8. The sample size for the training set:
The sample size for the training set is not explicitly stated. The text only mentions that the subject device's improved performance is "due to its training on a larger data set" compared to the predicate device, but does not provide a specific number for this larger data set. It also states the test set cases 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 text does not explicitly describe how the ground truth for the training set was established. It only refers to a "larger data set" used for training.

Summary

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May 15, 2024

Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K241112

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: April 22, 2024 Received: April 22, 2024

Dear John J. 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 OS 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).

Sincerely,

Samul for

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

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Indications for Use

Submission Number (if known)

Device Name

BriefCase-Quantification

Indications for Use (Describe)

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, Israel6706703
Phone: +972-73-7946870
Contact Person:	Amalia Schreier, VP of Regulatory Affairs
Date Prepared:	2024-05-13
Name of Device:	BriefCase-Quantification
Common or Usual Name:	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 Devices	BriefCase-Quantification (K230534)

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.

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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.

Intended Use / Indications for Use

Summary of Technological Characteristics

The subject BriefCase-Quantification device is substantially similar to the predicate device BriefCase-Quantification (K230534). Both devices are radiological computer-aided medical image management and processing software devices, intended to aid in measurement of radiological images.

Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations. Both are intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic diameter measurement. The subject device presents key slice with the long and short axis of the aorta in the reformatted slice with the maximum measurement, while the predicate device presents key slice in axial format.

The main difference between the subject and predicate device is the performance, due to its training on a larger data set, in that the subject device demonstrates improved performance over the predicate device. With regards to the indications for use, for the predicate device the indications refer to axial measurement of cases that include the abdominal aorta. For the subject device, measurement is orthogonal to the blood flow, therefore the word axial was omitted from the indications for use statement.

Both devices raise the same types of safety and effectiveness questions. A table comparing the key features of the subject and predicate devices is provided below:

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	Predicate Device:BriefCase-Quantification(K230534)	Subject Device:BriefCase-Quantification
Indications for Use/ Intended Use	BriefCase-Quantification is aradiological image andmanagement and processing system softwareindicated for use in the analysis of CT exams withcontrast, that include the abdominal aorta, in adults ortransitional adolescents aged 18 and older.The device is intended toassist appropriately trained medical specialists byproviding the user with themaximum abdominal aorticaxial diameter measurementof cases that include theabdominal aorta (M-AbdAo).BriefCase-Quantification isindicated to evaluate normaland aneurysmal abdominalaortas and is not intended toevaluate post-operativeaortas.The BriefCase-Quantification results are notintended to be used on astand-alone basis for clinicaldecision-making orotherwise preclude clinicalassessment of cases. Thesemeasurements areunofficial, are not final, andare subject to change afterreview by a radiologist. Forfinal clinically approvedmeasurements, please referto the official radiologyreport. Clinicians areresponsible for viewing fullimages per the standard ofcare.	BriefCase-Quantification is aradiological image andmanagement and processing system softwareindicated for use in the analysis of CT exams withcontrast, that include the abdominal aorta, in adults ortransitional adolescents aged 18 and older.The device is intended toassist appropriately trained medical specialists byproviding the user with themaximum abdominal aorticdiameter measurement ofcases that include theabdominal aorta (M-AbdAo).BriefCase-Quantification isindicated to evaluate normaland aneurysmal abdominalaortas and is not intended toevaluate post-operativeaortas.The BriefCase-Quantification results are notintended to be used on astand-alone basis for clinicaldecision-making orotherwise preclude clinicalassessment of cases. Thesemeasurements areunofficial, are not final, andare subject to change afterreview by a radiologist. Forfinal clinically approvedmeasurements, please referto the official radiologyreport. Clinicians areresponsible for viewing fullimages per the standard ofcare.
User Population	Appropriately trainedmedical specialists.	Appropriately trainedmedical specialists.
Anatomical region of interest	Abdominal aorta	Abdominal aorta
	Predicate Device:BriefCase-Quantification(K230534)	Subject Device:BriefCase-Quantification
Data acquisition protocol	CT exams with contrast thatinclude the abdominal aorta	CT exams with contrast thatinclude the abdominal aorta
Diameter Measurement	Yes	Yes
Measurement Method	Axial	Orthogonal
Images Format	DICOM	DICOM
Interference withstandard workflow	No	No
Preview images	Presentation of acompressed, grayscalepreview image that iscaptioned "Not for diagnosticuse".	Presentation of acompressed, grayscalepreview image that iscaptioned "Not for diagnosticuse".
Output	Maximum abdominal aorticdiameter with preview imagethat contains themeasurement and key slicewith the long and short axisof the aorta in the slice withthe maximum measurement.	Maximum abdominal aorticdiameter with preview imagethat contains themeasurement and key slicewith the long and short axisof the aorta in thereformatted slice composedof the plane that isorthogonal to the blood flowand not on the original axialslice.
Algorithm	Artificial intelligencealgorithm with database ofimages	Artificial intelligencealgorithm with database ofimages
Structure	- BriefCase-Quantification ishosted on a cloud server,analyzes applicable CTimages that are forwarded toBriefCase-Quantification.- The results of the analysisare exported in DICOMformat, and are sent to aPACS destination for reviewby medical specialists, toassist in the measurement ofthe abdominal aorta	- BriefCase-Quantification ishosted on a cloud server,analyzes applicable CTimages that are forwarded toBriefCase-Quantification.- The results of the analysisare exported in DICOMformat, and are sent to aPACS destination for reviewby medical specialists, toassist in the measurement ofthe abdominal aorta

Table 1: Comparison between Predicate and Subject Devices

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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 diameter measurements of the abdominal aorta in CT images in 162 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 was 1.52 mm (95% Cl: 1.20 mm, 1.83 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: 1.52 mm (95% C1: 1.20 mm, 1.83 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 the Abdominal Aortic Measurement was 62.8 years, with a standard deviation of 19.6 years. Gender distribution was 46.9% male, and 53.1% female (Table 3). Scanner distribution can also be found in Table 4 below.

	Mean	Std	Min	Median	Max	N
Age(Years)	62.8	19.6	18.0	67.5	90.0	162

Table 2. Descriptive Statistics for Age

Table 3. Frequency Distribution of Gender

Gender	N*	%
Male	76	46.9%
Female	86	53.1%

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

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Manufacturer	N	%
Philips	43	26.5%
Canon	41	25.3%
Siemens	39	24.1%
GE	39	24.1%
Total	162	100%

Table 4. Frequency Distribution of Manufacturer

Clinical Subgroups and Confounders: Preoperative abdominal 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 0.58 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 reference device demonstrated equivalent performance.

Conclusions

The subject and predicate BriefCase-Quantification for Abdominal Aortic Measurement (M-AbdAo) devices are intended to aid in medical image management and processing of radiological images in CT.

BriefCase-Quantification of M-AbdAo is as safe and effective as the predicate device cleared under K230534. BriefCase-Quantification has similar intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in the indications for use and in the technological characteristics do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. Performance data demonstrate that the subject device is as safe and effective as the predicate device. Thus, BriefCase-Quantification of M-AbdAo is substantially equivalent to the previously cleared BriefCase-Quantification of M-AbdAo device (K230534).

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).