(73 days)
Yes
The document explicitly states that the device "uses Artificial Intelligence (Al)algorithms" and "utilizes machine-learning and deep-learning algorithms". It also mentions an "Al algorithm" for the Pulmonary Density feature.
No
The device is described as image processing software that provides analysis, segmentation, and measurements from CT images to support clinicians in the evaluation and assessment of lung diseases. It does not provide any form of treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software provides "quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians... in the evaluation and assessment of disease of the lungs." This function of evaluating and assessing disease strongly points to a diagnostic purpose.
Yes
The device description explicitly states, "Al-Rad Companion is a software only medical system".
Based on the provided information, Al-Rad Companion (Pulmonary) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Al-Rad Companion (Pulmonary) Function: This device processes previously acquired Computed Tomography (CT) DICOM images. These images are generated from a medical imaging procedure performed on the patient's body (in vivo). The software analyzes these images to provide information about the lungs.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, Al-Rad Companion (Pulmonary) falls under the category of medical image processing software, which is a type of medical device, but not an IVD.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".
Intended Use / Indications for Use
Al-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality:
- Segmentation and measurements of complete lung and lung lobes
- Identification of areas with lower Hounsfield values in comparison to a predetined threshold for complete lung and lung lobes
- Providing an interface to external Medical Device syngo.CT Lung CAD
- Segmentation and measurements of found lung lesions and dedication to corresponding lung lobe.
- Identification of areas with elevated Hounsfield values. where areas with elevated versus high opacities are distinguished.
The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Al-Rad Companion is a software only medical system that investigates data from imaging systems. Al-Rad Companion receives these data and checks which post-processing algorithms may be applicable. Data that does not meet the Al-Rad Companion requirements are ignored while data that meets the requirements are sent for further processing. Applicable data are processed, and the results are provided to the user via their clinical workplace. The user has the option to accept, review or withdraw single results of Al-Rad Companion.
Al-Rad Companion includes a software operating platform (Al-Rad Companion (Engine)) and optional clinical extensions such as Al-Rad Companion (Pulmonary), Al-Rad Companion (Musculoskeletal) and Al-Rad Companion (Cardiovascular). The clinical extensions are post-processing applications that operate on the Al-Rad Companion (Engine) software platform and process CT datasets in specific regions of the thorax or use datasets from other modalities. The basic post-processing functions are landmark detection, segmentation, and classification. Al-Rad Companion uses Artificial Intelligence (Al)algorithms.
The Al-Rad Companion (Engine) platform is the interface for incoming and outgoing data for the complete Al-Rad Companion system that provides input data and collects results and status information from the extensions. Additionally, it is the interface for incoming and outgoing data for the complete Al-Rad Companion system.
The Al-Rad Companion extensions are optional post-processing applications that operate on the Al-Rad Companion (Engine) software platform. The platform and each of the extensions are distinct software components and thus separate medical devices.
The scope of this submission is the extension Al-Rad Companion (Pulmonary). It is an image postprocessing software that uses CT DICOM data to support clinicians in the evaluation and assessment of lung diseases. It utilizes machine-learning and deep-learning algorithms to provide quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the major functionalities of Al-Rad Companion (Pulmonary) are as follows:
- Segmentation and measurements of complete lung, lungs, and lung lobes.
- Identification of areas with lower Hounsfield values in comparison to a predefined threshold for . complete lung and lung lobes.
- . Segmentation and measurements of found lung lesions
- . Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished
The results will be delivered in different image formats and, depending on the configuration, can be verified in the Results Preview and will be included in the overview with all findings. This will include DICOM Structured Report with measurements results.
The software version VA13 of the Al-Rad Companion (Pulmonary) includes the following modifications:
-
Pulmonary Density
This feature provides the possibility to segment opacity regions inside the lung using an Al algorithm. Al-Rad Companion (Pulmonary) counts image voxels inside opacity regions and calculates the percentages of these voxels relative to the total number of voxels per lobe, lung and in total. Afterwards, the opacity results are assigned to a certain range as defined by Bernheim et al. -
Bi-directional lesion diameter
This feature provides an additional measurement derived from the existing segmentation contour of a lung lesion. The existing list of measurements is extended with the maximum orthogonal diameter in 2D (short axis diameter) which is orthogonal to the lesion's maximum 2D diameter (2D diameter, long axis diameter). -
Cloud and Edge Deployment
The system supports the existing cloud deployment as well as a new edge deployment. The system remains hosted in the teamplay digital health platform and remains driven by the Al-Rad Companion (Engine). Now the edge deployment allows the processing of clinical data and the generation of results on-premises within the customer network. The edge system is fully connected to the cloud for monitoring and maintenance of the system from remote.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography DICOM images
Anatomical Site
Lungs, chest
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice
Description of the training set, sample size, data source, and annotation protocol
Training cohort: size and properties of data used for training
Description of ground truth / annotations generation
Description of the test set, sample size, data source, and annotation protocol
Validation cohort: size and properties of data used for testing/validation
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Non-clinical tests (integration and functional) were conducted for Al-Rad Companion (Pulmonary) during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Clinical Evaluation of the Al-based Algorithms:
The following activities have been conducted for the syngo.CT Extended Functionality VB51 software application, to evaluate the feature Pulmonary Density which has been introduced with this application. The K-number is K203699 and it has been considered as the secondary predicate device for this submission K213096:
Clinical Data Based Software Validation:
The lung lobe segmentation algorithm computes segmentation masks of the five lung lobes (right upper (RUL), right middle (RML), right lower (RLL), left upper (LUL) and left lower (LLL) lobe) for a given CT data set of the chest.
The algorithm computes masks of opaque regions in the lung for a given CT data set of the chest. The opaque regions include ground glass opacities, consolidations and crazy-paving patterns. The calculation is done for each lobe as well as for the complete lung.
For each algorithm of Pulmonary Density the analysis is structured as follows:
- Algorithm Description: purpose, functionality, technical description
- Data
- Training cohort: size and properties of data used for training
- Description of ground truth / annotations generation
- Validation cohort: size and properties of data used for testing/validation
- Performance
- Choice of performance metric
- Actual performance results
- Assessment of clinical relevance of achieved performance
- Related clinical research, e.g. publications (if applicable) .
The results of clinical data-based software validation for the feature Pulmonary Density demonstrated equivalent performance in comparison to the primary predicate device for segmentation and lung parenchyma categorization.
Performance of lung lobe segmentation of Al-Rad Companion (Pulmonary) device has been validated using 250 datasets from multiple sites across the US and Europe. Average DICE coefficients ranged from 0.94 to 0.96.
Performance of the segmentation of opaque regions of Al-Rad Companion Pulmonary device has been validated using 150 datasets from multiple sites across the US and Europe. Interreader-variability of the percentage of opacity (PO) was assessed on a lung lobe level and 95%-Limits of Agreement (LoA) were established. The algorithm performance was compared against the human reads and 93.0% of the PO values were found within the LoA.
Additional analysis was performed for both population-specific subgroups and various technical parameters and consistent performance has been found for both algorithms across all subgroups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Average DICE coefficients ranged from 0.94 to 0.96 for lung lobe segmentation.
- 93.0% of the PO values were found within the LoA for segmentation of opaque regions.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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December 6, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.
Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE TN 37932
Re: K213096
Trade/Device Name: Al-Rad Companion (Pulmonary) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: September 23, 2021 Received: September 24, 2021
Dear Alaine Medio:
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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213096
Device Name AI-Rad Companion (Pulmonary)
Indications for Use (Describe)
Al-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality:
· Segmentation and measurements of complete lung and lung lobes
· Identification of areas with lower Hounsfield values in comparison to a predetined threshold for complete lung and lung lobes
· Providing an interface to external Medical Device syngo.CT Lung CAD
· Segmentation and measurements of found lung lesions and dedication to corresponding lung lobe.
· Identification of areas with elevated Hounsfield values. where areas with elevated versus high opacities are distinguished.
The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
| Type of Use (Select one or both, as applicable) |
|---|
| [X] 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
Prepared December 01, 2021
l. Identification of the Submitter
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany
Establishment Registration Number
3004977335
Submitter Contact Person:
Alaine Medio Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 206-0337 Fax: (865) 218-3019 Email: alaine.medio@siemens-healthineers.com
Secondary Contact Person:
Tabitha Estes Regulatory Affairs Specialist Phone: (865) 804-4553 Email: Tabitha.estes@siemens-healthineers.com
II. Device Name and Classification
| Product Name: | Al-Rad Companion (Pulmonary) |
|---|---|
| Propriety Trade Name: | Al-Rad Companion (Pulmonary) |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
4
| CFR Section: | 21 CFR §892.1750 |
|---|---|
| Device Class: | Class II |
| Product Code: | JAK |
Predicate Device III.
Primary Predicate Device:
| Trade Name: | Al-Rad Companion (Pulmonary) |
|---|---|
| 510(k) Number: | K183271 |
| Clearance Date: | 07/26/2019 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK, LLZ |
Secondary Predicate Device:
| Trade Name: | syngo.CT Extended Functionality |
|---|---|
| 510(k) Number: | K203699 |
| Clearance Date: | 04/30/2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
IV. Device Description
Al-Rad Companion is a software only medical system that investigates data from imaging systems. Al-Rad Companion receives these data and checks which post-processing algorithms may be applicable. Data that does not meet the Al-Rad Companion requirements are ignored while data that meets the requirements are sent for further processing. Applicable data are processed, and the results are provided to the user via their clinical workplace. The user has the option to accept, review or withdraw single results of Al-Rad Companion.
Al-Rad Companion includes a software operating platform (Al-Rad Companion (Engine)) and optional clinical extensions such as Al-Rad Companion (Pulmonary), Al-Rad Companion (Musculoskeletal) and Al-Rad Companion (Cardiovascular). The clinical extensions are post-processing applications that operate on the Al-Rad Companion (Engine) software platform and process CT datasets in specific regions of the thorax or use datasets from other modalities. The basic post-processing functions are landmark detection, segmentation, and classification. Al-Rad Companion uses Artificial Intelligence (Al)algorithms.
The Al-Rad Companion (Engine) platform is the interface for incoming and outgoing data for the complete Al-Rad Companion system that provides input data and collects results and status information
5
from the extensions. Additionally, it is the interface for incoming and outgoing data for the complete Al-Rad Companion system.
The Al-Rad Companion extensions are optional post-processing applications that operate on the Al-Rad Companion (Engine) software platform. The platform and each of the extensions are distinct software components and thus separate medical devices. A pictorial representation of the interaction between the Al-Rad Companion (Engine) and optional Al-Rad Companion extensions is provided in the figure below.
Image /page/5/Figure/2 description: The image shows a diagram of the AI-Rad Engine platform. The platform has an input and output, and several extensions, including AI-Rad Pulmonary, AI-Rad Cardiovascular, and AI-Rad Musculoskeletal. There is also a confirmation window/result preview box on top of the AI-Rad Engine platform. The AI-Rad Pulmonary extension is highlighted with a red box.
The scope of this submission is the extension Al-Rad Companion (Pulmonary). It is an image postprocessing software that uses CT DICOM data to support clinicians in the evaluation and assessment of lung diseases. It utilizes machine-learning and deep-learning algorithms to provide quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the major functionalities of Al-Rad Companion (Pulmonary) are as follows:
- Segmentation and measurements of complete lung, lungs, and lung lobes.
- ldentification of areas with lower Hounsfield values in comparison to a predefined threshold for . complete lung and lung lobes.
- . Segmentation and measurements of found lung lesions
- . Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished
The results will be delivered in different image formats and, depending on the configuration, can be verified in the Results Preview and will be included in the overview with all findings. This will include DICOM Structured Report with measurements results
6
The software version VA13 of the Al-Rad Companion (Pulmonary) includes the following modifications:
● Pulmonary Density
This feature provides the possibility to segment opacity regions inside the lung using an Al algorithm. Al-Rad Companion (Pulmonary) counts image voxels inside opacity regions and calculates the percentages of these voxels relative to the total number of voxels per lobe, lung and in total. Afterwards, the opacity results are assigned to a certain range as defined by Bernheim et al.
This feature has been cleared with the secondary predicate device syngo.CT Extended Functionality VB51 (K203699, clearance date 04/30/2021). It is a reuse from the predicate device to this subject device. The feature and its algorithms remain unchanged from this predicate device.
● Bi-directional lesion diameter
This feature provides an additional measurement derived from the existing segmentation contour of a lung lesion. The existing list of measurements is extended with the maximum orthogonal diameter in 2D (short axis diameter) which is orthogonal to the lesion's maximum 2D diameter (2D diameter, long axis diameter).
This feature has been cleared with the secondary predicate device syngo.CT Extended Functionality VB51 (K203699). It is a reuse from the predicate device to this subject device. For this feature, no modifications are required to the detection nor the segmentation of the lung lesions.
. Cloud and Edge Deployment
The system supports the existing cloud deployment as well as a new edge deployment. The system remains hosted in the teamplay digital health platform and remains driven by the Al-Rad Companion (Engine). Now the edge deployment allows the processing of clinical data and the generation of results on-premises within the customer network. The edge system is fully connected to the cloud for monitoring and maintenance of the system from remote.
V. Indications for Use
Al-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
lt provides the following functionality:
- Segmentation and measurements of complete lung and lung lobes
- ldentification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes
- . Providing an interface to external Medical Device syngo.CT Lung CAD
7
- Segmentation and measurements of found lung lesions and dedication to corresponding lung lobe
- Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished
The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
Comparison of Technological Characteristics with the Predicate Device VI.
The comparison between the above referenced predicate devices is listed in the following table. It compares each feature of the subject device either with the primary predicate device or the secondary predicate device.
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
|---|---|---|---|
| Al-Rad Companion | |||
| (Pulmonary) VA13A | |||
| (K213096) | Al-Rad Companion | ||
| (Pulmonary) VA10A | |||
| (K183271) | syngo.CT Extended | ||
| Functionality VB51 | |||
| (K203699) | |||
| Segmentation of Lung | |||
| Creation of a lung | |||
| segmentation mask by | |||
| combining the segmentation | |||
| masks of 5 lung lobes. | Creation of a lung | ||
| segmentation mask by | |||
| combining the segmentation | |||
| masks of 5 lung lobes. | Creation of a lung | ||
| segmentation mask by | |||
| combining the segmentation | |||
| masks of 5 lung lobes. | The same algorithm as cleared with | ||
| the predicate devices is used. |
Additional training data was added
as compared to the primary predicate
for the Pulmonary Density Feature.
This same data and method were
used with the secondary predicate
device (K203699). |
| Segmentation of Lobes | | | |
| Computation of segmentation
masks of the five lung lobes
(right upper (RUL), right
middle (RML), right lower
(RLL), left upper (LUL) and left
lower (LLL) lobe) for a given
CT data set of the chest. | Computation of segmentation
masks of the five lung lobes
(right upper (RUL), right
middle (RML), right lower
(RLL), left upper (LUL) and left
lower (LLL) lobe) for a given
CT data set of the chest. | Computation of segmentation
masks of the five lung lobes
(right upper (RUL), right
middle (RML), right lower
(RLL), left upper (LUL) and left
lower (LLL) lobe) for a given
CT data set of the chest. | This same data and method were
used with the secondary predicate
device (K203699). |
| Opacity Detection | | | |
| Al-based identification of
areas with elevated
Hounsfield values. Threshold-
based identification of
highest elevated Hounsfield
values inside these elevated
regions, by a predefined
threshold of -200 HU. | N/A | Al-based identification of
areas with elevated
Hounsfield values. Threshold-
based identification of
highest elevated Hounsfield
values inside these elevated
regions, by a predefined
threshold of -200 HU. | The Opacity Detection is the same as
the secondary predicate devices
syngo.CT Extended Functionality
(K203699). |
| Measurement Results | | | |
| Lung lesion, lung
parenchyma, and pulmonary
density measurements. | Lung lesion, and lung
parenchyma measurements. | Pulmonary density
measurements. | Extended with Pulmonary Density
results, as cleared in the secondary
predicate device (syngo.CT Extended
Functionality (K203699). |
| Parenchyma Evaluation | | | |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| Al-Rad Companion
(Pulmonary) VA13A
(K213096) | Al-Rad Companion
(Pulmonary) VA10A
(K183271) | syngo.CT Extended
Functionality VB51
(K203699) | |
| The parenchyma evaluation
uses the lobe mask, counts all
voxels per lobe, counts image
voxels below -950 HU, and
calculates the percentages of
these voxels relative to the
total number of voxels.
Additionally, it sums the
individual lobe results and
calculates the percentage for
the complete lung. | The parenchyma evaluation
uses the lobe mask, counts all
voxels per lobe, counts image
voxels below -950 HU, and
calculates the percentages of
these voxels relative to the
total number of voxels.
Additionally, it sums the
individual lobe results and
calculates the percentage for
the complete lung. | N/A | Same as the primary predicate device
Al-Rad Companion (Pulmonary)
VA10A (K183271). |
| Parenchyma Ranges | | | |
| The percentages are likewise
dedicated to the 4 ranges.
Name of ranges and their
ranges are configurable by
the user. | The percentages are likewise
dedicated to the 4 ranges.
Name of ranges and their
ranges are configurable by
the user. | N/A | |
| Visualization of Segmentation and Parenchyma Results | | | |
| Color overlay of MPR and VRT
with evaluation results. | Color overlay of MPR and VRT
with evaluation results. | N/A | |
| LungCAD Interface | | | |
| The external device syngo.CT
LungCAD is connected. | The external device syngo.CT
LungCAD is connected. | The external device syngo.CT
LungCAD is connected. | Same as both predicate devices. |
| Based on the positions
provided via the LungCAD
Interface, a segmentation of
suspicious lung areas is
started. Within the derived
contours the maximum
diameter within one slice, the
3-dimensional diameter, and
the volume are determined.
The lesion is dedicated to a
lung lobe.
Additionally, the maximum
orthogonal 2D diameter is
measured and the mean from
maximum 2D diameter and
maximum orthogonal 2D
diameter. | Based on the positions
provided via the LungCAD
Interface, a segmentation of
suspicious lung areas is
started. Within the derived
contours the maximum
diameter within one slice, the
3-dimensional diameter, and
the volume are determined.
The lesion is dedicated to a
lung lobe. | Based on positions provided
by the user, a segmentation
of suspicious lung areas is
started. Within the derived
contours the maximum
diameter within one slice, the
3-dimensional diameter, and
the volume are determined.
The lesion is dedicated to a
lung lobe.
Additionally, the maximum
orthogonal 2D diameter is
measured and the mean from
maximum 2D diameter and
maximum orthogonal 2D
diameter is shown. | The Bi-directional lesion diameter is
the same as the secondary predicate
device syngo.CT Extended
Functionality VB51 (K203699). |
8
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
Non-clinical tests (integration and functional) were conducted for Al-Rad Companion (Pulmonary) during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
9
Clinical Evaluation of the Al-based Algorithms
The following activities have been conducted for the syngo.CT Extended Functionality VB51 software application, to evaluate the feature Pulmonary Density which has been introduced with this application. The K-number is K203699 and it has been considered as the secondary predicate device for this submission K213096:
Clinical Data Based Software Validation
The following algorithms underwent a scientific evaluation:
-
-Segmentation of lung lobes
The lung lobe segmentation algorithm computes segmentation masks of the five lung lobes (right upper (RUL), right middle (RML), right lower (RLL), left upper (LUL) and left lower (LLL) lobe) for a given CT data set of the chest. -
-Identification of opaque regions (Al-based) The algorithm computes masks of opaque regions in the lung for a given CT data set of the chest. The opaque regions include ground glass opacities, consolidations and crazy-paving patterns. The calculation is done for each lobe as well as for the complete lung.
For each algorithm of Pulmonary Density the analysis is structured as follows: -
Algorithm Description: purpose, functionality, technical description ●
-
. Data
- Training cohort: size and properties of data used for training O
- o Description of ground truth / annotations generation
- Validation cohort: size and properties of data used for testing/validation O
-
Performance
- O Choice of performance metric
- O Actual performance results
- O Assessment of clinical relevance of achieved performance
-
Related clinical research, e.g. publications (if applicable) .
The results of clinical data-based software validation for the feature Pulmonary Density demonstrated equivalent performance in comparison to the primary predicate device for segmentation and lung parenchyma categorization.
Performance of lung lobe segmentation of Al-Rad Companion (Pulmonary) device has been validated using 250 datasets from multiple sites across the US and Europe. Average DICE coefficients ranged from 0.94 to 0.96.
Performance of the segmentation of opaque regions of Al-Rad Companion Pulmonary device has been validated using 150 datasets from multiple sites across the US and Europe. Interreader-variability of the percentage of opacity (PO) was assessed on a lung lobe level and 95%-Limits of Agreement (LoA) were established. The algorithm performance was compared against the human reads and 93.0% of the PO values were found within the LoA.
Additional analysis was performed for both population-specific subgroups and various technical parameters and consistent performance has been found for both algorithms across all subgroups.
10
Risk Analysis
The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results demonstrate that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Siemens hereby certifies that Al-Rad Companion (Pulmonary) meets the following voluntary standards covering electrical and mechanical safety listed below:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|--------------------------|----------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| 13-79 | Software | Medical Device Software –Software Life Cycle
Processes; 62304:2006 (1st Edition) | 01/14/2019 | AAMI, ANSI, IEC |
| 5-125 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971 Third
Edition 2019-12 | 12/23/2019 | ISO |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 12/23/2016 | IEC |
VIII. Conclusion
Al-Rad Companion (Pulmonary) has the same intended use and similar indication for use as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and as the predicate device that is currently marketed for the same intended use.
For the subject device, Al-Rad Companion (Pulmonary) VA13, Siemens used the same testing with the same workflows as used to clear the predicate device in addition to the clinical evaluation. Siemens considers Al-Rad Companion (Pulmonary) version VA13 to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.