(23 days)
Not Found
Yes
The document explicitly states "Following the AI processing, the output of the algorithm analysis is transferred to an image review software".
No
The device is described as an image management and processing system software intended to assist medical specialists by providing measurements for diagnosis and assessment, rather than directly treating a condition or performing therapy.
No
The device description explicitly states, "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist," and the "Intended Use / Indications for Use" section indicates that "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."
Yes
The device description explicitly states that BriefCase-Quantification is a "radiological medical image management and processing device" and that 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." It receives and processes DICOM images, and its output is transferred to existing image review software and PACS. There is no mention of any proprietary hardware component being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: BriefCase-Quantification processes radiological images (CT scans) of the abdominal aorta. It does not analyze any biological samples.
The device falls under the category of medical image processing software, specifically utilizing AI for quantitative analysis of anatomical structures within those images.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
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 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.
Product codes
QIH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT exams with contrast that include the abdominal aorta
Anatomical Site
abdominal aorta
Indicated Patient Age Range
adults or transitional adolescents aged 18 and older.
Intended User / Care Setting
appropriately trained medical specialists.
Description of the training set, sample size, data source, and annotation protocol
The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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.
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.
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.
Key Metrics
Mean Absolute Error: 1.52 mm (95% Cl: 1.20 mm, 1.83 mm)
Mean difference between the ground truth compared to the algorithm output: 0.58 mm
Predicate Device(s)
BriefCase-Quantification (K230534)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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
2
Indications for Use
Submission Number (if known)
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 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 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.
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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3
510(K) SUMMARY
Aidoc Medical, Ltd.'s BriefCase-Quantification
Submitter
| Aidoc Medical, Ltd. | |
|---|---|
| 3 Aminadav St. | |
| Tel-Aviv, Israel | |
| 6706703 | |
| 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
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.
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
4
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
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.
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:
5
| | Predicate Device:
BriefCase-Quantification
(K230534) | Subject Device:
BriefCase-Quantification |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use/ Intended Use | BriefCase-Quantification is a
radiological image and
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 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. | BriefCase-Quantification is a
radiological image and
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. |
| User Population | Appropriately trained
medical specialists. | Appropriately trained
medical 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 that
include the abdominal aorta | CT exams with contrast that
include the abdominal aorta |
| Diameter Measurement | Yes | Yes |
| Measurement Method | Axial | Orthogonal |
| Images Format | DICOM | DICOM |
| Interference with
standard workflow | No | No |
| Preview images | Presentation of a
compressed, grayscale
preview image that is
captioned "Not for diagnostic
use". | Presentation of a
compressed, grayscale
preview image that is
captioned "Not for diagnostic
use". |
| Output | Maximum abdominal aortic
diameter with preview image
that contains the
measurement and key slice
with the long and short axis
of the aorta in the slice with
the maximum measurement. | Maximum abdominal aortic
diameter with preview image
that contains the
measurement and key slice
with the long and short axis
of the aorta in the
reformatted slice composed
of the plane that is
orthogonal to the blood flow
and not on the original axial
slice. |
| Algorithm | Artificial intelligence
algorithm with database of
images | Artificial intelligence
algorithm with database of
images |
| Structure | - 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 in DICOM
format, and are sent to a
PACS destination for review
by medical specialists, to
assist in the measurement of
the abdominal aorta | - 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 in DICOM
format, and are sent to a
PACS destination for review
by medical specialists, to
assist in the measurement of
the abdominal aorta |
Table 1: Comparison between Predicate and Subject Devices
6
7
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
8
| 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).