(146 days)
Yes
The document explicitly mentions the use of Convolutional Neural Networks (CNNs) for various components of the algorithm, including candidate generation, classification, post-filtering, and lung segmentation. CNNs are a type of deep learning algorithm, which falls under the umbrella of AI/ML.
No.
The device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of pulmonary nodules. It does not provide any direct therapeutic intervention or treatment.
Yes.
The device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of pulmonary nodules during the review of CT scans. Its purpose is to alert the radiologist to regions of interest that may indicate the presence of disease, which is a diagnostic assistance function.
Yes
The device is described as a software algorithm that processes images and provides output to a separate visualization application. It explicitly states it does not have its own user interface for displaying marks and relies on a "Hosting Application" for this. The description focuses entirely on the software's functionality and processing capabilities, without mentioning any associated hardware components included in the device submission.
Based on the provided text, the syngo.CT Lung CAD 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, or tissue, to provide information about a person's health.
- This device analyzes medical images: The syngo.CT Lung CAD device processes and analyzes medical images (CT scans) to assist radiologists in identifying potential pulmonary nodules. It does not interact with or analyze biological samples.
The device falls under the category of medical image analysis software, specifically a Computer-Aided Detection (CAD) tool.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The syngo.CT Lung CAD device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
Product codes
OEB
Device Description
Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules (between 3.0 mm and 30.0mm) and subsolid (partsolid and ground glass) nodules (between 5.0 mm and 30.0mm) in average diameter. The device processes images acquired with multi-detector CT scanners with 16 or more detector rows.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular).
The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images to enable the radiologist's review. syngo MM Oncology (FDA clearance K191309) is deployed on the syngo.via platform (FDA clearance K191040), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device may be used either as a concurrent first reader, followed by a review of the case, or as a second reader only after the initial read is completed
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Multi-detector Computed Tomography (MDCT)
Anatomical Site
Chest/Lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists; Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
20 readers reviewed all of 232 cases using both a second-reader as well as a concurrent first reader workflows. Following the read according to both workflows, five expert radiologists reviewed all consolidated marks. The reference standard was based on reader majority (three out of five) followed by expert adjudication, as needed. As a result of the study's truthing process, 143 cases were identified as including at least one true nodule and 89 with no true nodules.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The statistical analyses aimed at substantiating the safety and effectiveness of LungCAD VD20. The aim of the pivotal study was that of assessing the effect on readers' diagnostic accuracy when using Lung CAD, relative to their unaided accuracy.
20 readers reviewed all of 232 cases using both a second-reader as well as a concurrent first reader workflows. Following the read according to both workflows, five expert radiologists reviewed all consolidated marks. The reference standard was based on reader majority (three out of five) followed by expert adjudication, as needed. As a result of the study's truthing process, 143 cases were identified as including at least one true nodule and 89 with no true nodules.
All endpoints of the analyses were satisfactorily met. These analyses demonstrated that all readers showed a significant improvement for the detection of pulmonary nodules (solid, part-solid and ground glass) with both reading workflows.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
March 31, 2021
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.
Siemens Healthcare GmbH % Mr. Abhineet Johri Regulatory Affairs Manager Siemensstr. 1 Forchheim, 91301 GERMANY
Re: K203258
Trade/Device Name: syngo.CT Lung CAD (VD20) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: OEB Dated: February 19, 2021 Received: February 22, 2021
Dear Mr. Abhineet:
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 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.
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)
K203258
Device Name syngo.CT Lung CAD (VD20)
Indications for Use (Describe)
The syngo.CT Lung CAD device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
The syngo. CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read.
The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
Date prepared: November 04, 2020
1. Submitter (Legal Manufacturer):
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Mr. Abhineet Johri Regulatory Affairs Manager Siemens Healthcare GmbH, 65-3 Valley Stream Parkway Malvern, PA 19355. U.S.A E-mail: abhineet.johri@siemens-healthineers.com Telephone: +1 (484) 680-8723 Fax: +1 610-448-6557
3. Device Name and Classification:
| Trade Name: | syngo.CT Lung CAD (Version VD20) |
|---|---|
| Classification Name: | Lung computed tomography system, computer-aided detection |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | OEB |
4. Legally Marketed Predicate Device:
Trade Name: syngo.CT Lung CAD (Version VC30)
4
| 510(k) Clearance: | K193216 |
|---|---|
| Clearance Date: | March 2020 |
| Classification Name: | Lung computed tomography system, computer-aided detection |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | OEB |
| Recall Information: | This predicate device has not been the subject of any |
| design related recalls. |
5. Device Description:
Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules (between 3.0 mm and 30.0mm) and subsolid (partsolid and ground glass) nodules (between 5.0 mm and 30.0mm) in average diameter. The device processes images acquired with multi-detector CT scanners with 16 or more detector rows.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular).
The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images to enable the radiologist's review. syngo MM Oncology (FDA clearance K191309) is deployed on the syngo.via platform (FDA clearance K191040), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device may be used either as a concurrent first reader, followed by a review of the case, or as a second reader only after the initial read is completed
The subject device and predicate device have the same basic technical characteristics. This does not introduce new types of safety or effectiveness concerns as demonstrated by the statistical analyses and results of the reader study and additional evaluations results documented in the Statistical Analysis.
6. Intended Use:
syngo.CT Lung CAD software device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of pulmonary nodules during review of multi-detector computed tomography examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
5
7. Indications for Use:
The syngo.CT Lung CAD device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read. The software device is an algorithm which does not have its own user interface
component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
Safety and Effectiveness Information
Software design description, hazard analysis, and technical and safety information have also been completed and provided in support of this device. The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 2005.
The device has no PHI and is utilized only by trained professionals. The output of the device is evaluated by trained professionals as a concurrent first reader or as a second reader. Use of this device does not impact the quality or status of the original acquired data.
Substantial Equivalence:
This premarket notification assesses that while Siemens syngo. CT Lung CAD VD20 introduces changes to the cleared device (syngo.CT Lung CAD VC30) in the indications for use and extends the workflow to concurrent first reader, the technological characteristics of the product and intended use have remained unchanged.
Specifically, both the predicate VC30 and VD20 share the same algorithm based on Convolutional Neural Networks (CNN) and the same basic architectural workflow. However, VD20C extends the indication for use of VC30 by introducing:
6
- (1) new AI models for Candidate Generation and Classification components to support the extension of the claims.
- (2) regional configurability of the workflow so that the device, subject to configuration controls, may be also used for outside the US Market.
- (3) a post-filtering module (also CNN-based) aimed at reducing false positives caused by bony protrusions or detections in the colon.
- (4) bug-fixes to address apical or basal-lungs under-segmentation.
These extensions do not introduce new types of safety or effectiveness questions. As demonstrated by (a) the statistical analysis following the MRMC reader study and results of the standalone Mark Overlap evaluations. Specifically:
- i. The results from the analysis of the retrospective reader study meet the end points and as such validate that the new device VD20 (point 1 above) is safe and effective
- Regional configurability does not impact the safety and effectiveness of the device ii. as the configurability does not affect the workflow nor the operational aspects of the device.
- iii. The reduction of false positives by post-filtering (point 3 above) and bug-fixes (point 4 above) are subjects of the standalone analysis which has demonstrated that the marks generated by the two devices are reasonably consistent.
Note: The substantial equivalence comparison is performed with the previously cleared VC30 version of this device, as reflected in the predicate labeling and provided in the 510(k) cleared in March 2020 (K193216).
In summary, Siemens Healthcare GmbH is of the opinion that the syngo.CT Lung CAD software, as described within this document, does not pose any unmitigated safety risks and is substantially equivalent to the predicate device.
8. Summary of Differences between the Subject Device and the Predicate Device:
The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison Table 1 and Table 2 below.
7
| Subject
Device
Characteristic | Current Predicate Device
syngo.CT Lung CAD (VC30) (K193216) | New Device
syngo.CT Lung CAD (VD20) | Type of Change and Impact to
Safety & Effectiveness |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | [Unchanged]
No Impact |
| Detection target | Solid pulmonary nodules in diagnostic
chest CT acquisitions | Solid and subsolid (part-solid and
ground-glass) pulmonary nodules in
screening and diagnostic chest CT acqui-
sitions | [Updated]
Reflecting parameters validated in the
reader study. |
| Intended Use | The LungCAD software device is a Com-
puter-Aided Detection (CAD) tool de-
signed to assist
radiologists in the detection of solid pul-
monary nodules during review of multi-
detector
computed tomographic (MDCT) thoracic
examinations. The software is an adjunc-
tive tool
that alerts the radiologist to regions of in-
terest (ROI) that may be initially over-
looked. The
LungCAD software device use is in-
tended to be used as a second reader
after the radiologist has completed
his/her initial read. | syngo.CT Lung CAD software device is a
Computer-Aided Detection (CAD) tool de-
signed to assist radiologists in the detec-
tion of pulmonary nodules during review
of multi-detector computed tomography
(MDCT) thoracic examinations. The soft-
ware is an adjunctive tool to alert the ra-
diologist to regions of interest (ROI) that
may otherwise be overlooked. | [Updated]
Reflecting key aspects for the intended
use. Details that explicitly relate to the
indication for use have been removed
and are included in the indications for
use (see below). |
8
| Indications For Use | The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo.CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read. | The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked. The syngo.CT Lung CAD device maybe be used as a concurrent first reader, followed by a full review of the case by the radiologist or as a second reader after the radiologist has completed his/her initial read. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface. | [Updated] Reflecting parameters validated in the reader study.
Extensions include: subsolid (part-solid and ground glass) nodules multivendor (Siemens, Ge, Philips, and Toshiba concurrent first reader workflow clarification on the fact that the device does not have its own user interface |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
9
| Nodule
| Characteristics | Size Solid ≥ 3mm and ≤ 20mm Locations full range: central, peripheral Contours: round, irregular | Diameter Solid ≥ 3mm and ≤ 30mm Subsolid (part-solid and ground glass) ≥ 5mm and ≤ 30mm Locations full range: central, peripheral Contours: round, irregular | [Extended] Solid nodules to 30mm Included Subsolid (part-solid and ground glass) nodules Validated by reader study |
|---|---|---|---|
| Reader | |||
| Workflow | second reader workflow | concurrent first reader OR | |
| second reader workflow | [Updated] | ||
| Reflecting parameters validated in the | |||
| reader study. | |||
| Input scanning | |||
| parameters | Scanners | ||
| Siemens multi-detector CT (MDCT) | |||
| scanners. | Scanners | ||
| Multi-vendor and multi-detector CT | |||
| (MDCT) scanners (Siemens, GE, Philips, | |||
| and Toshiba) | [Updated] | ||
| Reflecting parameters validated in the | |||
| reader study. | |||
| Detector rows | |||
| 4 or more detector rows | Detector rows | ||
| 16 or more detector rows | [Updated] | ||
| Recommendation to use 16 or more | |||
| detector rows included, as recom- | |||
| mended by FDA, | |||
| Reflecting parameters validated in the | |||
| reader study. | |||
| Scan area | |||
| The scan area needs to comprise the | |||
| entire thorax covering the lung apices to | |||
| the bases | Scan area | ||
| The scan area needs to comprise the en- | |||
| tire thorax covering the lung apices to the | |||
| bases (single breath hold recommended) | [Updated] | ||
| Clarification added; no Impact | |||
| Scan direction | |||
| Cranio-caudal or caudal-cranial | Scan direction | ||
| Cranio-caudal or caudal-cranial | [Unchanged] | ||
| No Impact | |||
| Voltage | Voltage | [Updated] | |
| 120 -140 kVp | 100 -140 kVp | Reflecting parameters validated in the | |
| reader study. | |||
| Exposure | None | [Removed] | |
| 40–120 mAs | Aspect captured by the Dose recommendation | ||
| Collimation | Collimation | [Unchanged] | |
| 1 mm or less | 1 mm or less | No Impact | |
| Slice width | Slice Thickness | [Updated] | |
| 1.00 - 1.25 mm | Up to and including 2.5mm, it is recommended that 1 This component was added in version d into VD20C (September 2020). It has been validated as part of the VD20+ paired overlap analysis. |
14
9. Statistical Analysis Summary
The statistical analyses aimed at substantiating the safety and effectiveness of LungCAD VD20. The aim of the pivotal study was that of assessing the effect on readers' diagnostic accuracy when using Lung CAD, relative to their unaided accuracy.
20 readers reviewed all of 232 cases using both a second-reader as well as a concurrent first reader workflows. Following the read according to both workflows, five expert radiologists reviewed all consolidated marks. The reference standard was based on reader majority (three out of five) followed by expert adjudication, as needed. As a result of the study's truthing process, 143 cases were identified as including at least one true nodule and 89 with no true nodules.
All endpoints of the analyses were satisfactorily met. These analyses demonstrated that all readers showed a significant improvement for the detection of pulmonary nodules (solid, part-solid and ground glass) with both reading workflows.
The statistical analyses have provided the required evidence to demonstrate that the primary as well as the secondary endpoints were met; thus, demonstrating that the new device syngo.CT Lung CAD VD20 is substantially equivalent to the predicate syngo.CT Lung CAD VC30.
Hence, the new device was shown to be: (a) as safe and effective as the legally marketed predicate device and (b) not to raise questions of safety and effectiveness compared to the predicate device with respect to the extensions of the indication for use.
10. Non-clinical Performance Testing:
Non-clinical performance testing was performed at various levels for verification and validation of the device intended use and to ensure safety and effectiveness.
The protocol of the tests follows the testing activities of the software development and quality management process. This protocol, which ensures both verification and validation, is structured at different levels of product testing to ensure that the above objectives are met. These are:
- Unit test: Verify the Design Specification, Risk Mitigations, identify runtime er-. rors and memory leaks, and Verify the Logic.
- Integration test: Verify the correct implementation of the design and test coverage . specified by the software requirements and Design Specifications. The
15
Implementation and effectiveness of Risk mitigation classified as Hazard is also checked (Hazard Tests).
- System test: It is performed on the integrated product comprising the software . units and components.
- . System Validation: Validate the intended use defined in the requirements specifications and risk labelling mitigations. These requirements will be validated using one of the Hosting Applications.
Tests specifications used for the test levels mentioned above include test descriptions, test environment, and the test cases with the requirements that were tested. Tests are passed only based on the defined acceptance criteria. To ensure continuous quality of the software, automatic testing with GUI- (graphical user interface) and Non-GUI-based tests are performed to cover the software's functionality. The basis for the test automation is described in the corresponding Test Specifications. The matching of automated test cases and test results is ensured through code reviews of the automation scripts.
Siemens Healthcare GmbH claims conformance to the following standards:
- -ISO 14971:2007Second edition 2007-03-01
- IEC 62304 Edition 1.1 2015-06 Consolidated Version -
- IEC 62366-1 Edition 1.0 2015-02 -
11. Software Verification and Validation:
Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.CT Lung CAD during product development.
The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
16
Summary:
Performance tests were conducted to test the functionality of the device syngo.CT Lung CAD . These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
12. Safety and Effectiveness Information:
Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
13. Conclusion as to Substantial Equivalence:
This premarket notification assesses that while Siemens syngo. CT Lung CAD VD20 introduces change to the cleared device (syngo.CT Lung CAD VC30) in the indication for use and extends the workflow to concurrent first reader, the technological characteristics of the product and intended use have remained unchanged.
Specifically, both the predicate VC30 and VD20 share the same algorithm based on Convolutional Neural Networks (CNN) and the same basic architectural workflow. The bug fixes and addition of the postfiltering do not introduce new types of safety or effectiveness questions. As demonstrated in the statistical analysis following the MRMC reader study and results of the standalone Mark Overlap evaluations.
The substantial equivalence comparison is performed with the previously cleared VC30 version of this device, as reflected in the predicate labeling and provided in the 510(k) cleared in March 2020 (K193216).
In summary, Siemens Healthcare GmbH is of the opinion that the syngo.CT Lung CAD software, as described within this document, does not pose any unmitigated safety risks and is substantially equivalent to the predicate device since its accuracy has been shown to be superior to the predicate device and the marks are reasonably consistent.