syngo.CT Lung CAD (Version VD30)
Device Facts
| Record ID | K231157 |
|---|---|
| Device Name | syngo.CT Lung CAD (Version VD30) |
| Applicant | Siemens Healthcare GmbH |
| Product Code | OEB · Radiology |
| Decision Date | Jul 19, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K231157 · Jul 19, 2023 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | Retrospective clinical thoracic CT cases (UCLA study, original PMA study, and additional clinical cases) | The retrospective clinical dataset was used to perform a standalone benchmark evaluation to demonstrate substantial equivalence between the subject device (VD30) and the predicate device (VD20), specifically comparing sensitivity and false positive rates. | Retrospective clinical data; Thoracic CT; Pulmonary nodules; Standalone performance evaluation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Standalone performance evaluation (retrospective); Retrospective performance evaluation using existing clinical cases; Follow-up/Duration: Not applicable | Patients undergoing thoracic CT examinations; Sample Size: 712 CT thoracic cases | syngo.CT Lung CAD (VD20) | Sensitivity and mean number of false positives per subject |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Pulmonary Nodule Detection | CNN with cascaded filter banks | — | Sensitivity of VD30 in solid-only mode is not inferior to VD20 in standard mode; mean number of false positives per subject is significantly lower with VD30 in solid-only mode. | 712 CT thoracic cases (232 UCLA study, 145 original PMA study, 335 additional cases). | 18 (readers) + 7 (readers) | 712 CT thoracic cases (232 UCLA study, 145 original PMA study, 335 additional cases). | 18 (readers) + 7 (readers) |
Indications for 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(MDCT) examinations of the thorax (chest). The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
Device Story
Software-based CAD tool for thoracic MDCT images; assists radiologists in identifying solid/subsolid pulmonary nodules. Input: MDCT chest scans (16+ detector rows). Processing: CNN-based algorithm performs lung segmentation, candidate generation, and multi-stage classification/filtering to identify nodules. Output: CAD marks superimposed on images via hosting application (e.g., syngo MM Oncology). Used in clinical settings by radiologists; functions as concurrent first reader or second reader. Benefits: alerts radiologists to potential nodules that might be overlooked, improving detection efficiency. 'Solid-only' mode filters out non-solid/calcified findings to reduce false positives.
Clinical Evidence
Retrospective standalone performance evaluation using 712 thoracic CT cases (929 true nodules). Compared VD30 (standard and solid-only modes) against VD20. Endpoints: sensitivity and mean false positives per subject. Results: VD30 solid-only mode sensitivity non-inferior to VD20 standard mode; mean false positives per subject significantly lower in VD30 solid-only mode. All primary and secondary endpoints met.
Technological Characteristics
Software-only device; CNN-based algorithm. Operates on syngo.via platform. Input: MDCT thoracic images (16+ detector rows). Connectivity: Networked via hosting application. Software class: Moderate level of concern. Conforms to ISO 14971:2019, IEC 62304:2015, IEC 62366-1:2015.
Indications for Use
Indicated for radiologists to assist in detection of solid and subsolid pulmonary nodules (3.0-30.0mm solid; 5.0-30.0mm subsolid) in MDCT chest examinations. Used as concurrent first reader or second reader. Includes optional 'solid-only' mode to filter out sub-solid and fully calcified findings.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- syngo.CT Lung CAD (Version VD20) (K203258)
Reference Devices
Submission Summary (Full Text)
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July 19, 2023
Siemens Healthcare GmbH % Abhineet Johri Regulatory Affairs Manager Siemensstr. 1 Forchheim, 91301 GERMANY
Re: K231157
Trade/Device Name: syngo.CT Lung CAD (Version VD30) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OEB Dated: June 28, 2023 Received: June 30, 2023
Dear Abhineet Johri:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radialogical Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### K231157
Device Name syngo.CT Lung CAD (Version VD30)
#### Indications for Use (Describe)
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid 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 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 syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
|X| Prescription Use (Part 21 CFR 801 Subpart D)
O 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: July 18th, 2023
### 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, 40 Liberty Blvd Malvern, PA 19355. U.S.A E-mail: abhineet.johri@siemens-healthineers.com Telephone: +1 (484) 680-8723
#### 3. Device Name and Classification:
| Trade Name: | syngo.CT Lung CAD (Version VD30) |
|-----------------------|-----------------------------------------------------------|
| Classification Name: | Medical image management and processing system |
| Classification Panel: | Radiology |
| Common Name: | Lung computed tomography system, computer-aided detection |
| 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 VD20) |
|----------------------|------------------------------------------------|
| 510(k) Clearance: | K203258 |
| Clearance Date: | March 31, 2021 |
| Classification Name: | Medical image management and processing system |
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| Classification Panel: | Radiology |
|-----------------------|----------------------------------------------------------------------------------|
| Common Name: | Lung computed tomography system, computer-aided detection |
| 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<br>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 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 recommended.
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 clearanceK211459 and subsequent versions ) is deployed on the syngo.via platform (FDA clearance k191040 and subsequent versions), 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 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(MDCT) examinations of the thorax (chest). The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked.
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## 7. Indications for Use:
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid 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 may 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 syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
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 VD30 introduces changes to the cleared device (syngo.CT Lung CAD VD20, K203258) in the indications for use, the technological characteristics for of the product have remained unchanged.
Specifically, both the predicate VD20 and the subject device VD30 share the same algorithm based on Convolutional Networks (CNN) and the same basic architectural workflow. However, VD30 extends the indication for use of VD20 by introducing:
- The syngo.CT Lung CAD device may also be used in "solid-only" mode, I. where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out.
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This extension does not introduce new types of safety or effectiveness questions. As demonstrated by the statistical analysis and the results of the standalone benchmark evaluation:
- I. The standalone accuracy has shown that the sensitivity of VD30 in solidonly mode is not inferior to VD20 in standard mode
- II. The mean number of false positives per subject is significantly lower with VD30 in solid-only mode
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.
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| Subject<br>Device<br>Characteristic | Current Predicate<br>Device<br>syngo.CT Lung CAD<br>(VD20) (K203258) | New Device<br>syngo.CT Lung CAD<br>(VD30) | Type of Change and<br>Impact to Safety & Ef-<br>fectiveness |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Manufacturer | Siemens Healthcare<br>GmbH | Siemens Healthcare<br>GmbH | [Unchanged]<br>No Impact |
| Detection target | Solid and subsolid pul-<br>monary nodules in<br>screening and diagnos-<br>tic chest CT acquisi-<br>tions | Solid and subsolid<br>pulmonary nodules in<br>screening and diag-<br>nostic chest CT acqui-<br>sitions | [Unchanged]<br>No Impact |
| Intended Use | syngo.CT Lung CAD<br>software device is a<br>Computer-Aided De-<br>tection (CAD) tool de-<br>signed to assist radiol-<br>ogists in the detection<br>of pulmonary nodules<br>during review of multi-<br>detector computed to-<br>mography (MDCT) ex-<br>aminations of the<br>thorax (chest). The<br>software is an adjunc-<br>tive tool to alert the ra-<br>diologist to regions of<br>interest (ROI) that may<br>otherwise be<br>overlooked. | syngo.CT Lung CAD<br>software device is a<br>Computer-Aided De-<br>tection (CAD) tool<br>designed to assist ra-<br>diologists in the de-<br>tection of pulmonary<br>nodules during review<br>of multi-detector com-<br>puted tomography<br>(MDCT) examina-<br>tions of the thorax<br>(chest). The software<br>is an adjunctive tool<br>to alert the radiologist<br>to regions of interest<br>(ROI) that may other-<br>wise be overlooked. | [Unchanged]<br>No impact |
| Indications For Use | | | [Updated] |
| The <i>syngo.CT</i> Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multivendor, 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 be otherwise overlooked. The <i>syngo.CT</i> Lung CAD device is to be used either as a concurrent first reader, followed by radiologist review, 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 <i>syngo.CT</i> Lung CAD is responsible for implementing a user interface. | <i>syngo.CT</i> Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid 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 <i>syngo.CT</i> Lung CAD device may 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 <i>syngo.CT</i> Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out. The software de- | Included a solid only mode to enable only displaying solid nodules (excluding fully calcified nodules and non-solid nodules) | |
| | | algorithm which<br>does not have its<br>own user interface<br>component for<br>displaying of<br>CAD marks. The<br>hosting Applica-<br>tion incorporating<br>syngo.CT Lung<br>CAD is responsi-<br>ble for implement-<br>ing a user inter-<br>face. | |
| Nodule<br>Characteristics | Size<br>Solid ≥ 3 mm and<br>≤ 30mm Subsolid ≥ 5 mm<br>and ≤ 30 mm Locations<br>full range: central,<br>peripheral Contours:<br>round, irregular | Diameter<br>Solid ≥ 3 mm and<br>≤ 30mm Subsolid ≥ 5 mm<br>and ≤ 30 mm Locations<br>full range: central,<br>peripheral Contours:<br>round, irregular | [Unchanged]<br>No impact |
| Reader<br>Workflow | concurrent first reader<br>OR<br>second reader work-<br>flow | concurrent first reader<br>OR<br>second reader work-<br>flow | [Unchanged]<br>No impact |
| Input scanning param-<br>eters | Scanners<br>Multi-vendor and<br>multi-detector CT<br>(MDCT) scanners. | Scanners<br>Multi-vendor and<br>multi-detector CT<br>(MDCT) scanners. | [Unchanged]<br>No Impact |
| | Detector rows<br>16 or more detector<br>rows recommended | Detector rows<br>16 or more detector<br>rows recommended | [Unchanged]<br>No impact |
| | Scan area<br>The scan area needs to<br>comprise the entire<br>thorax covering the<br>lung apices to the bases<br>(single breath hold rec-<br>ommended) | Scan area<br>The scan area needs to<br>comprise the entire<br>thorax covering the<br>lung apices to the ba-<br>ses (single breath hold<br>recommended) | [Unchanged]<br>No impact |
| | Scan direction<br>Cranio-caudal or cau-<br>dal cranial | Scan direction<br>Cranio-caudal or cau-<br>dal cranial | [Unchanged]<br>No Impact |
| Voltage | Voltage | [Unchanged] | |
| 100-140 kVp | 100-140 kVp | No impact | |
| Collimation | Collimation | [Unchanged] | |
| 1 mm or less | 1 mm or less | No Impact | |
| Slice Thickness | Slice Thickness | [Unchanged] | |
| Up to and including<br>2.5 mm with<br>1.25 mm preferred | Up to and including<br>2.5 mm with<br>1.25 mm preferred | No Impact | |
| Slice overlap | Slice Overlap | [Unchanged] | |
| 0-50%<br>Note: Reconstruction<br>overlap is allowed, but<br>gaps are not permitted | 0-50%<br>Note: Reconstruction<br>overlap is allowed,<br>but gaps are not per-<br>mitted | No impact | |
| Kernel | Kernel | [Unchanged] | |
| Consistent with tho-<br>racic CT protocols and<br>in line with patient<br>safety<br>guidelines. Kernels<br>were grouped as to<br>their profile. Typical<br>kernels<br>validated by the reader | Consistent with tho-<br>racic CT protocols<br>and in line with pa-<br>tient safety<br>guidelines. Kernels<br>were grouped as to<br>their profile. Typical<br>kernels<br>validated by the<br>reader study were: | No impact | |
| study were: | | | |
| Smooth: B, B30f,<br>Standard, FC10.<br>Medium: C, B45f,<br>B50f, Lung, FC50,<br>FC51, Bv49d_2,<br>I50f_2, B60f.<br>Sharp: D, B70f, Bone,<br>FC52 | Smooth: B, B30f,<br>Standard, FC10.<br>Medium: C, B45f,<br>B50f, Lung, FC50,<br>FC51, Bv49d_2,<br>I50f_2, B60f.<br>Sharp: D, B70f, Bone,<br>FC52 | | |
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| | Dose | Dose | [Unchanged] |
|--------------------------|-------------------------|--------------------------|-------------|
| | Consistent with tho- | Consistent with tho- | No impact |
| | racic CT protocols and | racic CT protocols | |
| | in line with patient | and in line with pa- | |
| | safety guidelines. | tient safety guidelines. | |
| | Typical values are: | Typical values are: | |
| | CTDIvol $<$ 8.0 mGy | CTDIvol $<$ 8.0 mGy | |
| | (milligray) in diagnos- | (milligray) in diagnos- | |
| | tic protocols and | tic protocols and | |
| | CTDIvol of = 3.0 mGy | CTDIvol of = 3.0 | |
| | in screening protocols. | mGy in screening pro- | |
| | These values are de- | tocols. These values | |
| fined for standard sized | are defined for stand- | | |
| patient—5 ft 7 in., 154 | ard sized patient—5 ft | | |
| lb (170 cm, 70 kg)— | 7 in., 154 lb (170 cm, | | |
| based on a 32-cm ref- | 70 kg)—based on a | | |
| erence phantom with | 32-cm reference phan- | | |
| appropriate reductions | tom with appropriate | | |
| in CTDIvol for smaller | reductions in CTDIvol | | |
| patients and appropri- | for smaller patients | | |
| ate increases in | and appropriate in- | | |
| CTDIvol for larger pa- | creases in | | |
| tients.None | CTDIvol for larger | | |
| | patients.None | | |
| Hosting Platform | syngo.via | syngo.via | [Unchanged] |
| | | | No impact |
| Hosting Application | syngo MM Oncology | syngo MM Oncology | [Unchanged] |
| | | | No impact |
Table 1 Summary of Differences between the Subject Device and the Predicate Device
| Functional Compo-<br>nent | LungCAD VD20 | LungCAD VD30 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preprocessing<br>Standardization of<br>the input images and<br>lung segmentation | (a) isotropic volume<br>resampling and image<br>standardization. | (a). Isotropic volume resampling and<br>image standardization |
| | (b) lung segmentation is ac-<br>complished using a CNN.<br>Initially a coarse estimation<br>of the lung is performed us-<br…
