(181 days)
Salix Central is a web-based software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
This software provides tools that can be used for the qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT.
Salix Central is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional's comprehensive diagnostic decision-making process. The software's semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining and evaluating cardiac CT images.
Salix Central is a web-based software application, hosted on AWS cloud services, delivered using a SaaS model. The software provides interactive, post-processing tools for trained radiologists or cardiologists for viewing, and characterizing cardiac computed tomography (CT) image data obtained from a CT scanner. The physician-driven coronary analysis is used to review CT image data to prepare a standard coronary report that may include the presence and extent of physician-identified coronary plaques (i.e., atherosclerosis) and stenosis, and assessment of calcified plaque (calcium scoring). The Cardiac CT image data are physician-ordered and typically obtained from patients who underwent CCTA or CAC CT for evaluation of CAD or suspected CAD.
Here's a breakdown of the acceptance criteria and study details for Salix Central, based on the provided document:
Acceptance Criteria and Device Performance
| Salix Central Output | Statistic | Acceptance Criteria | Reported Device Performance (Estimate [95% CI]) | Result |
|---|---|---|---|---|
| Calcium Scoring | Pearson Correlation | 0.90 | 0.958 [0.947, 0.966] | Pass |
| Centerline Extraction | True Placement Percentage | 78% | 90.4% [88.5%, 92.2%] | Pass |
| Vessel Labelling | F1 Score | 70% | 78.4% [76.1%, 80.5%] | Pass |
| Lumen Wall Segmentation | Dice Score | 0.80 | 0.8996 (0.8938, 0.9055) | Pass |
| Vessel Wall Segmentation | Dice Score | 0.80 | 0.9016 (0.8962, 0.9070) | Pass |
Study Details
1. Sample Sizes Used for the Test Set and Data Provenance
- Total Unique Cases for Validation: 363 unique, de-identified cardiac CT studies.
- Specific Test Set Sizes:
- Calcium Scoring: 302 non-contrast series.
- Centerline Extraction and Vessel Labelling: 116 contrast-enhanced series.
- Wall Segmentation (Lumen and Vessel Wall): 63 contrast-enhanced series.
- Data Provenance: Sourced from multiple unique centers in the USA. The data did not contribute to any training datasets for Salix Central algorithms. It included representation of multiple CT scanner manufacturers (Canon, GE, Philips, and Siemens). The study cohort included diverse demographics: 36% age 65+, 57% female, 67% White, 18% Black or African American, 13% Asian, and 19% Hispanic or Latino. The document indicates this was a retrospective evaluation as it refers to "sourced from" and "validation dataset consisted of" existing studies.
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a specific number, but "board certified cardiologists with SCCT Level 3 certification (or equivalent experience)" were used. This implies multiple experts collaborated in establishing the ground truth, rather than a single individual.
- Qualifications of Experts: Board certified cardiologists with SCCT Level 3 certification (or equivalent experience).
3. Adjudication Method for the Test Set
- The document states that the ground truth "was independently established from the source clinical image interpretation" by qualified cardiologists. It does not explicitly describe an adjudication method (e.g., 2+1, 3+1) if there were discrepancies among experts, but rather implies a consensus or single, definitive reference standard decided upon by these experts.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the ML-enabled algorithms against an established ground truth.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance validation testing presented describes the standalone performance of the ML-enabled Salix Central outputs (calcium scoring, centerline extraction, vessel labelling, and lumen/vessel wall segmentation) against a reference ground truth. The results are reported as direct comparisons of the algorithm's output to the expert-established ground truth.
6. The Type of Ground Truth Used
- Expert Consensus/Manual Annotation: The ground truth was "established by board certified cardiologists with SCCT Level 3 certification (or equivalent experience) using manual annotation tools." This indicates an expert-derived ground truth based on manual interpretation and annotation of the images.
7. The Sample Size for the Training Set
- Training Dataset Size: 3835 unique patient cases.
8. How the Ground Truth for the Training Set was Established
- A "reference standard was created to train the machine (ML) enabled algorithms in Salix Central." While the specific methodology for ground truth establishment for the training set isn't detailed, it is implied that it was also based on creating a "reference standard" consistent with the clinical context as the validation set. Data for training was sampled from their database based on pre-defined exclusion criteria, ensuring no site was shared between training and validation cohorts.
- Data Provenance for Training Set: 6 unique sites from the USA, Canada, Australia, and Japan.
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Artrya Limited Gabriela Quijada Quality and Regulatory Manager 1257 Hay Street West Perth PERTH. WA 6005 AUSTRALIA
March 27, 2025
Re: K243038 Trade/Device Name: Salix Central Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OIH Dated: February 27, 2025 Received: February 27, 2025
Dear Gabriela Quijada:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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).
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Sincerely,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software DHT8B: Division of Radiologic 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
Submission Number (if known)
K243038
Device Name
Salix Central
Indications for Use (Describe)
Salix Central is a web-based software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
This software provides tools that can be used for the qualitative assessment of physicianidentified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT.
Salix Central is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional's comprehensive diagnostic decision-making process. The software's semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining cardiac CT images.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K243038
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date Prepared: | February 25, 2025 |
|---|---|
| Submitter: | Artrya Ltd. |
| Official Contact: | Gabriela Quijada1257 Hay StreetWest Perth, 6005, AustraliaPhone: +61 405 653 605 |
| Proprietary Name: | Salix Central |
| Common Name: | System, Image Processing, Radiological |
| Classification: | Class II Medical DeviceRequlation Number: 21 CFR 892.2050Product Code: QIH |
| Predicate Device: | cvi42 Auto Imaging Software Application (K213998) |
| Reason For Submission: | New Traditional 510(k) |
Indications for Use
Salix Central is a web-based software application that is intended to be used for viewing, postprocessing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
This software provides tools that can be used for the qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT.
Salix Central is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional's comprehensive diagnostic decision-making process. The software's semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining and evaluating cardiac CT images.
Device Description
Salix Central is a web-based software application, hosted on AWS cloud services, delivered using a SaaS model. The software provides interactive, post-processing tools for trained radiologists or cardiologists for viewing, and characterizing cardiac computed tomography (CT)
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image data obtained from a CT scanner. The physician-driven coronary analysis is used to review CT image data to prepare a standard coronary report that may include the presence and extent of physician-identified coronary plaques (i.e., atherosclerosis) and stenosis, and assessment of calcified plaque (calcium scoring). The Cardiac CT image data are physicianordered and typically obtained from patients who underwent CCTA or CAC CT for evaluation of CAD or suspected CAD.
A reference standard was created to train the machine (ML) enabled algorithms in Salix Central. Data for training and validation sampled from our database based on pre-defined exclusion criteria. Data were also selected to ensure no site was shared by training and validation cohorts. The training dataset included 3835 unique patient cases from 6 unique sites from the USA, Canada, Australia and Japan.
Substantial Equivalence Discussion
Salix Central is substantially equivalent to the predicate, cvi42 Auto Imaging Software Application (K213998). Both devices and the reference device, iNtuition-Structural Heart Module (K191585), have the same Intended Use/Indications for Use and are similar with respect to key features and performance characteristics. The Predicate Device & Reference Device Comparison Table below provides a comparison between the Salix Central and the predicate device cvi42 Auto Imaging Software Application (K213998) and reference device, iNtuition-Structural Heart Module (K191585):
| Predicate Device & Reference Device Comparison | |||
|---|---|---|---|
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle CardiovascularImaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto ImagingSoftware Application | iNtuition-Structural HeartModule |
| 510(k) Number | Subject Device: K243038 | K213998 | K191585 |
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| Predicate Device & Reference Device Comparison | |||
|---|---|---|---|
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle CardiovascularImaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto ImagingSoftware Application | iNtuition-Structural HeartModule |
| 510(k) Number | Subject Device: K243038 | K213998 | K191585 |
| Intended Use /Indications forUse | Salix Central is a web-based software applicationthat is intended to be usedfor viewing, post-processing, and analyzingcardiac computedtomography (CT) imagesacquired from a CTscanner in a Digital Imagingand Communications inMedicine (DICOM)Standard format.This software providestools that can be used forthe qualitative andquantitative assessment ofphysician-identifiedcoronary plaques andstenosis in coronarycomputed tomographyangiography (CCTA) and toperform calcium scoring innon-contrast cardiac CT. | cvi42 Auto is intended tobe used for viewing, post-processing, qualitativeand quantitativeevaluation ofcardiovascular magneticresonance (MR) andcomputed tomography(CT) images in a DigitalImaging andCommunications inMedicine (DICOM)Standard format. Itenables a set of tools toassist physicians inqualitative assessment ofcardiac images andquantitativemeasurements of theheart and adjacentvessels; perform calciumscoring; and to confirmthe presence or absenceof physician-identifiedlesion in blood vessels. | iNtuition-Structural HeartModule is a softwaresolution that is intended toassist Cardiologists,Radiologists and ClinicalSpecialists with thevisualization andmeasurements ofstructures of the heart andvessels. iNtuition-Structural Heart Moduleenables the user to: -Visualize and measure(diameters, lengths,angles, areas andvolumes) structures of theheart and vessels for pre-operative planning andsizing for cardiovascularinterventions and surgery,and for post- operativeevaluation. - Quantifycalcium (volume, density)- iNtuition-Structural HeartModule has the following |
| Predicate Device & Reference Device Comparison | |||
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle CardiovascularImaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto ImagingSoftware Application | iNtuition-Structural HeartModule |
| 510(k) Number | Subject Device: TBD | K213998 | K191585 |
| Salix Central is intended tocomplement standard careas an adjunctive tool and isnot intended as areplacement to a medicalprofessional'scomprehensive diagnosticdecision-making process.The software's semi-automated features areintended for an adultpopulation and should onlybe used by qualifiedmedical professionalsexperienced in examiningand evaluating cardiac CTimages. | The target population forcvi42 Auto's manualworkflows is notrestricted; however, SalixCentral's semi-automatedmachine learningalgorithms are intendedfor an adult population.cvi42 Auto shall be usedonly for cardiac imagesacquired from an MR orCT scanner. It shall beused by qualified medicalprofessionals,experienced in examiningand evaluatingcardiovascular MR or CTimages, for the purpose ofobtaining diagnosticinformation as part of acomprehensive diagnosticdecision-making process. | tools and features thatfacilitate: - Automatic andmanual centerlinedetection. - Segmentationof cardiovascularstructures | |
| Device Class | II | II | II |
| DeviceClassification | QIH | LLZ, QIH | LLZ |
| Intended Users | Cardiologists, Radiologistsand Clinical Specialists | Qualified MedicalProfessionals | Cardiologists,Radiologists and ClinicalSpecialists |
| OperatingPlatform | Client-Server GoogleChrome Application | macOS, MicrosoftWindows | Microsoft Windows |
| DICOMCompliant | Yes; DICOM 3.0 or higher | Yes | Yes |
| ImageAcquisition | CT | MR and CT | CT, MR, Nuc, PET, Angio,US/Echo, SPECT |
| SecuredNetwork ServerIntegration | Yes | Yes | Yes |
| Store Images | Yes | Yes | Yes |
| 2D Imaging | Yes | Yes | Yes |
| 3D Imaging | Yes | Yes | Yes |
| MultiplanarReformat(MPR) | Yes | Yes | Yes |
| Study Analysis- NavigationTools | PanningWindowingZooming | PanningWindowingZooming | Yes |
| Predicate Device & Reference Device Comparison | |||
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle CardiovascularImaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto ImagingSoftware Application | iNtuition-Structural HeartModule |
| 510(k) Number | Subject Device: TBD | K213998 | K191585 |
| Series, slices, and phases | Series, slices, and phases | Series, slices, and phases | |
| Study Analysis- Visualizationand Editing | CenterlineWallSignal Intensity Overlay | Yes | Yes |
| Measurements | DistanceDiameterAreaHounsfield Unit (HU)Lumen % diameterreduction | DistancePerimeterAreaHounsfield Unit (HU)Volume | Yes |
| CenterlineExtraction andWallSegmentation | Manual and semi-automatic/ user-editable | Manual and semi-automatic using MachineLearning technique | Semi-automatic |
| CalciumScoring | Yes | Yes | Yes |
| Reporting | Yes | Yes | Yes |
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Performance Testing
Performance testing was conducted to verify compliance with specified design requirements in accordance with FDA 21 CFR Part 820.30, IMDRF/SaMD WG/N12FINAL:2014, ISO 13485:2016, IEC 62304:2015, ISO 14971:2019 and NEMA 3.1-3.20 (2016) DICOM standards.
Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".
Salix Central has been tested according to the specifications that are documented in a master Software Verification and Validation Plan. Performance testing is an integral part of Artrya's software product development process as described in the company's Quality Management System Policies and Procedures.
Performance Validation Testing:
Performance validation testing was performed for the ML-enabled Salix Central outputs for calcium scoring. centerline extraction, vessel labelling, and lumen and vessel wall segmentation against reference ground truth established by board certified cardiologists with SCCT Level 3 certification (or equivalent experience) using manual annotation tools. In each case the reference was independently established from the source clinical image interpretation.
Data for the validation was sourced from multiple unique centers in the USA that did not contribute any data to the training datasets for any Salix Central algorithm.
The validation dataset consisted of 363 unique, de-identified cardiac CT studies from six (6) centers across three (3) US states. This consisted of 302 non-contrast series for the testing of calcium scoring, 116 contrast-enhanced series for the testing of centerline extraction and vessel labelling, and 63
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contrast-enhanced series for the testing of wall segmentation. Each validation test included representation of multiple scanner manufacturers (i.e., Canon, GE, Philips, and Siemens) and disease severity based on calcium score and maximum stenosis (CAD-RADS classification) based on the source clinical radiology reports.
The combined dataset consisted of:
- 36% age 65 and above (median age 60) ●
- 57% Female .
- 67% White, 18% Black or African American, and 13% Asian ●
- . 19% Hispanic or Latino
Salix Central performance exceeded all the pre-defined acceptance criteria for all validation tests.
| Salix Central Output | Statistic | Estimate [95% CI] | Acceptance Criteria | Result |
|---|---|---|---|---|
| Calcium Scoring | Pearson Correlation | 0.958[0.947, 0.966] | 0.90 | Pass |
| Centerline Extraction | True PlacementPercentage | 90.4%[88.5%, 92.2%] | 78% | Pass |
| Vessel Labelling | F1 Score | 78.4%[76.1%, 80.5%] | 70% | Pass |
| Lumen Wall Segmentation | Dice Score | 0.8996(0.8938, 0.9055) | 0.80 | Pass |
| Vessel Wall Segmentation | Dice Score | 0.9016(0.8962, 0.9070) | 0.80 | Pass |
Conclusion
In summary, the comprehensive performance testing and comparison to the predicate cvi42 Auto Imaging Software Application (K213998) demonstrates that Salix Central is substantially equivalent to the named predicate device.
§ 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).