(107 days)
CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images.
CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis.
CariCloud analysis results are indicated for use for all patients referred for CCTA imaging.
CariCloud is an image processing prescription software device intended to be used to display, manipulate and quantify previously acquired CT images.
Datasets are downloaded from remote systems for clinical interpretation. Trained users will initiate and oversee image analysis and intervene when necessary to correct processing errors. The outcome of analysis will be used to create a summary report that includes qualitative and quantitative analysis.
Here's a breakdown of the acceptance criteria and study information for CariCloud v1.0, based on the provided text:
Acceptance Criteria and Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device (TeraRecon iNtuition) through performance testing related to inter-operator and intra-operator variability in measurements. The acceptance criteria aren't explicitly stated as numerical thresholds for specific metrics, but rather derived from the performance of the predicate device and the conclusion that the new device's performance is "excellent" and shows "no significant difference."
| Acceptance Criteria (Implied) | Reported Device Performance (CariCloud v1.0) |
|---|---|
| Inter-Operator Variability (ICC) | |
| - PFA: Excellent (comparable to predicate's 0.998-0.999) | - Reader 1: 0.997 |
| - TVOI-A: Excellent (comparable to predicate's 0.983-0.986) | - Reader 2: 0.997 |
| - TVOI-V: Excellent (comparable to predicate's 0.973-0.991) | - Reader 3: 0.994 |
| - TROI-A: Excellent (comparable to predicate's 1.0) | - Reader 1: 0.987 |
| Intra-Operator Variability (ICC) | - Reader 2: 0.971 |
| - ICC > 0.96 for all measures | - Reader 3: 0.982 |
| - Maximum difference in ICC between devices ≤ 0.017 | - Reader 1: 0.971 |
| No significant difference in inter- or intra-operator variability | Conclusion: "No significant difference between the inter-operator variability and intra-operator variability results attained on the two devices." and "For all measures, the intra-operator agreement achieved on both the predicate device and the new device for each operator was excellent (ICC greater than 0.96) with a maximum difference in ICC between the two devices was 0.017." |
| Safety and Effectiveness | Conclusion: "CariCloud v1.0 does not raise any new questions of safety or effectiveness as compared to the predicate device." |
Note: The specific meaning of PFA, TVOI-A, TVOI-V, and TROI-A are not explicitly defined in the provided document, but they represent different measures of attenuation in coronary arteries and surrounding tissue in CCTA images, as indicated by the device's intended use.
Study Details: Performance Testing - Inter-operator and Intra-operator Variability
-
Sample size used for the test set and the data provenance:
- The document does not specify the sample size (number of cases/patients) used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "Reader 1," "Reader 2," and "Reader 3" in the ICC table, indicating that three operators were involved in the testing.
- The qualifications of these operators are not provided. The Indications for Use state "CariCloud is to be used by trained operators," implying these readers were trained on the device.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document states that ICC values were calculated "between individual results of each read by each operator on each device for each measure based on an average-rating, absolute-agreement, 2-way mixed-effects model." This implies that the individual reads of each operator were compared against each other, rather than against a single adjudicated ground truth derived from multiple experts. Therefore, a formal adjudication method like 2+1 or 3+1 for ground truth establishment is not mentioned and appears not applicable in the context of this inter/intra-operator variability study.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This document describes a study comparing the performance consistency (inter-operator and intra-operator variability) of the device itself (CariCloud v1.0) and a predicate device, as measured by human readers using them. It is not an MRMC comparative effectiveness study evaluating the improvement of human readers with AI assistance versus without AI assistance. Therefore, no such effect size is reported.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The testing described focuses on human operators using the device to make measurements. It is a "software device used by operators to evaluate attenuation." While the device itself performs analysis, the performance metrics reported here (ICC values) are derived from "individual results of each read by each operator." Therefore, a standalone (algorithm-only) performance study, independent of human interaction or measurement, is not explicitly described or reported in this section. The device's description does mention "trained users will initiate and oversee image analysis and intervene when necessary to correct processing errors," suggesting active human involvement.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the inter-operator and intra-operator variability study, the "ground truth" for the ICC calculation is effectively the agreement between the operators' measurements themselves, or the agreement of an individual operator's repeated measurements. It does not refer to an independent, definitive medical ground truth like pathology or outcomes data. The study assesses the consistency of measurements obtained using the devices.
-
The sample size for the training set:
- The document does not provide information regarding the sample size of any training set used for the CariCloud v1.0 software.
-
How the ground truth for the training set was established:
- Since no training set information is provided, there is also no information on how the ground truth for any training set might have been established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Caristo Diagnostics % Mr. James Davis Head of Quality and Regulatory Affairs New Barclay House, 234 Botley Road Oxford, Oxfordshire OX20HP UNITED KINGDOM
Re: K200274
Trade/Device Name: CariCloud v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 1, 2020 Received: May 4, 2020
Dear Mr. Davis:
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
May 21, 2020
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200274
Device Name CariCloud v1.0
Indications for Use (Describe) The indications for use, are as follows:
CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images.
CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis.
CariCloud analysis results are indicated for use for all patients referred for CCTA imaging.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
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Image /page/3/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with the word "diagnostics" in a smaller, light gray font underneath. To the left of the word "Caristo" is a circular graphic made up of three concentric arcs in dark gray, red, and orange.
SUBMITTER l.
Caristo Diagnostics New Barclay House 234 Botley Road Oxford OX2 0HP Phone: +44 (0) 1865 950720 Contact Person: James Davis Date Prepared: May 01, 2020
DEVICE ll.
Name of Device: CariCloud v1.0 Common or Usual Name: CariCloud Classification Name: Picture archiving and communications (21 CFR§ 892.2050) Regulatory Class: II Product Code: LLZ
PREDICATE DEVICE lll.
TeraRecon iNtuition, K121916 This predicate has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
CariCloud is an image processing prescription software device intended to be used to display, manipulate and quantify previously acquired CT images.
Datasets are downloaded from remote systems for clinical interpretation. Trained users will initiate and oversee image analysis and intervene when necessary to correct processing errors. The outcome of analysis will be used to create a summary report that includes qualitative and quantitative analysis.
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Image /page/4/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, sans-serif font, with the word "diagnostics" in a smaller, lighter font underneath. To the left of the word "Caristo" is a stylized "C" made up of three concentric arcs in red, orange, and yellow. The logo is simple and modern, and the colors are bright and eye-catching.
INDICATIONS FOR USE
The Indications for use are as follows:
- . CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images.
- . CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis.
- . CariCloud analysis results are indicated for use for all patients referred for CCTA imaging.
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Image /page/5/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with the letter "C" stylized with concentric circles in black, red, and orange. Below "Caristo" is the word "diagnostics" in a smaller, light gray font.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE
The following table compares CariCloud v1.0 to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, forming the basis for the determination of substantial equivalence.
| Attribute | CariCloud | iNtuition | Comparison |
|---|---|---|---|
| Manufacturer | Caristo Diagnostics | TeraRecon. INC | Not Applicable |
| 510(k)Number | K200274 | K121916 | Not Applicable |
| ProductCode | LLZ | LLZ | Same |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Intended Use/ Indicationsfor Use | CariCloud is a softwaredevice used by operators toevaluate attenuation inthe coronary arteries andsurrounding tissue in CCTAimages.CariCloud is to be used bytrained operators. CariCloudanalysis results are to beused by HealthcareProfessionals and mayassist in diagnosis.CariCloud analysis resultsare indicated for use for allpatients referred for CCTAimaging. | To receive, store, transmit,post-process, display andallow manipulation of reportsand medical images fromacquisition devices, includingoptical or other non-DICOMformat images, DICOMimages with modality type XA,US, CR, DR, SPECT, NM andMG, and images fromvolumetric medical scanningdevices such as EBT, CT,PET or MRI.To provide access to imagesderived data and derivedimages via client-serversoftware, web browser andmobile technology.Visualization in 2D, 3D and4D are supported for single ormultiple datasets, orcombinations thereofTools are provided to defineand edit paths throughstructures such as centerlines,which may be used to analyzecross-sections of structures, orto provide flythroughvisualizations rendered alongsuch a centerline | CariCloud and TeraRecon'siNtuition device can both beused to evaluate attenuationin the coronary arteries andsurrounding tissue in CTimages.CariCloud andTeraRecon's iNtuitiondevice differ in that iNtuitionhas additional features andsupports use in evaluatingimages from othermodalities and diagnosticareas such as oncology andneurology.The fact that TeraRecon'siNtuition device supportsadditional modalities anddiagnostic areas does notaffect the safety andeffectiveness of CariCloudbecause the additionalfunctionality offered byiNtuition is unrelated to thesafety and effectiveness ofCCTA image analysis. |
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Image /page/6/Picture/1 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with the word "diagnostics" in a smaller, lighter gray font underneath. To the left of the word "Caristo" is a graphic element consisting of concentric arcs in red, orange, and yellow, creating a circular design.
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Image /page/7/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a dark gray, sans-serif font, with the word "diagnostics" in a smaller, lighter gray font underneath. To the left of the word "Caristo" is a stylized "C" made up of concentric arcs in red, dark gray, orange, and yellow.
| Attribute | CariCloud | iNtuition | Comparison | |||
|---|---|---|---|---|---|---|
| Interpretation ofmammographic images ordigitized film screen images issupported only when thesoftware is used withoutcompression and with an FDA-Approved monitor that offersat least SMpixel resolution andmeets other technicalspecifications reviewed andaccepted by the FDA.iNtuitionMOBILE provideswireless and portable accessto medical images. This deviceis not intended to replace fullworkstations and should beused only when there is noaccess to a workstation. Notintended for diagnostic usewhen used via a web browserormobile device.iNtuition will be marketed as asoftware only solution for theend-user (with recommendedhardware requirements) or asa complete workstation for theend user (software packagewith harware kit). | ||||||
| Technical Characteristics | ||||||
| Data Type | - CT- 3D Medical Image Review | - CT, MR, Nuc, PET, Angio,US/Echo, SPECT, CR/DRReview | CariCloud supports CTreview. This difference doesnot affect the safety of thedevice. | |||
| - 2D, 3D, 4D Medical Imagereview including cine play | ||||||
| Input PatientData | - Manual throughkeyboard/mouse | - Manual throughkeyboard/mouse | The same as the predicatedevice. | |||
| - Command line interface. | - Command line interface | |||||
| Study listfunctionality | - Search | - Importing- Exporting- Deleting- Search | CariCloud does not supportimport, export, delete andanonymization. Thisdifference does not affectthe safety of the device. | |||
| - Anonymization |
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Image /page/8/Picture/0 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, sans-serif font, with the "C" stylized as a series of concentric arcs in red, orange, and yellow. Below "Caristo" is the word "diagnostics" in a smaller, lighter gray font. The overall design is modern and professional.
| Attribute | CariCloud | iNtuition | Comparison |
|---|---|---|---|
| CenterlineExtraction | - Automatic and manualcenterlines | - Automatic and manualcenterlines | The same as the predicatedevice. |
| - Centerline edits andrefinements. | - Centerline edits andrefinements. | ||
| - Vessel Analysis | - Vessel Analysis | ||
| - Automatic and manualsegmentation of structures- Segmentation editing | - Automatic and manualsegmentation of structures- Segmentation editing | ||
| ImageAssessment | - Linear (length, diameter),distance and ROImeasurements | - Linear (length, diameter,perimeter), distance pair,angular and ROImeasurements | CariCloud supports a sub-set of the imageassessment tools that are inthe predicate device. Thisdoes not affect the safety ofthe device. |
| - Area measurements | - Area measurements | ||
| - Volume measurementsincluding VOI andthresholding | - Volume measurementsincluding volumetrichistogram, VOI and TVA forTime Volume Analysis forheart chamber segmentationand analysis | ||
| - Segmentation and analysisof coronary artery treecenterline | - C-arm angulation calculation | ||
| - Synchronized side-by-sidereview | - Text and arrow annotations | ||
| - Synchronized center ofrotation viewing | - Anatomy ID (Landmark LabelSelection) | ||
| - Calcium scoring forassessment of calcium in theaortic root | |||
| - Calcium scoring forassessment of calcium in thecoronary arteries- Segmentation and analysisof coronary artery treecenterline- Synchronized side-by-sidereview- Synchronized center ofrotation viewing |
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Image /page/9/Picture/1 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font. Below "Caristo" is the word "diagnostics" in a smaller, light gray font. To the left of the word "Caristo" is a graphic of three partial circles in yellow, orange, and red.
| Attribute | CariCloud | iNtuition | Comparison |
|---|---|---|---|
| - Findings workflow fortemporal correlative analysis2D/3D Batch movie tool andexport- 2D/3D Batch movie tool andexport | |||
| ImageAssessmentRendering | - MPR- 3D triangulation- Curved Planar Reformat(CPR)- Synchronized side-by- sideviewing- Synchronized center ofrotation viewing- Multi-Mask Display (multi-object display)- Editing tools: free- hand | - 2D/3D Batch movie tool andexport- MIP , MPR, MinIP ,- Raysum (ThickMPR)- 3D triangulation- Perspective endoluminalview- Medial Axial Reformat (MAR)- Curved Planar Reformat(CPR)- Double-oblique MIP andMPR- Image enhancement filters- Synchronized side-by- sideviewing- Synchronized center of | CariCloud supports a sub-set of the imageassessment rendering toolsthat are in the predicatedevice. This does not affectthe safety of the device. |
| rotation viewing- Cube View |
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Image /page/10/Picture/1 description: The image is a logo for Caristo diagnostics. The logo has the word "Caristo" in a dark gray font, with the word "diagnostics" in a light gray font underneath. To the left of the word "Caristo" is a graphic of three concentric arcs in red, orange, and yellow.
| Attribute | CariCloud | iNtuition | Comparison |
|---|---|---|---|
| - Workflow templates- Multi-Mask Display (multi-object display)- User-defined measurementprotocols- Editing tools: crop, cut, free-hand | |||
| Storage ofresults | DICOM SC | - Structured reporting with xml,text, xls output- Word and html report- DICOM SC- Workflow scenes: restoresaved state | CariCloud supports a sub-set of the result storagetools that are in thepredicate device. This doesnot affect the safety of thedevice. |
| ConferencingandCollaboration | Not supported. | Conferencing andCollaboration | Not supported. This doesnot affect the safety of thedevice. |
| OperatingSystem | Any operating system thatsupports the ChromeBrowser. | Microsoft Windows | CariCloud is supported onthe Chrome Browser. Thisdoes not affect the safety ofthe device. |
The agreement in results, inter-operator variability and intra-operator variability attained using both the new device and the predicate device was excellent.
CariCloud v1.0 does not raise any new questions of safety or effectiveness as compared to the predicate device.
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Image /page/11/Picture/0 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with a stylized "C" that incorporates segments of red, orange, and yellow. Below "Caristo" is the word "diagnostics" in a lighter gray font. The logo is clean and modern, suggesting a company focused on medical diagnostics.
PERFORMANCE DATA VI.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for CariCloud v1.0 is Moderate, as per FDA's quidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This device does not control a life supporting or life-sustaining device, does not control the delivery of a potentially harmful energy, does not control the delivery of treatment, does not provide diagnostic information, and does not provide any vital signs monitoring. The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented.
Performance Testing
CariCloud v1.0 software has been developed and tested in accordance with the Caristo Diagnostics Design Control processes and has been subject to extensive safety and performance testing. Nonclinical verification and validation testing has been performed to demonstrate that CariCloud v1.0 meets its design requirements and intended use. Software verification has been conducted at unit and system integration levels. A risk analysis was performed to document the risks associated with the use of the CariCloud v1.0 software product with all identified risks being mitigated. Cybersecurity and data security testing has been conducted to verify that data and patient protected health information security measures are included in the design of the software.
Based on the Verification and Validation testing that has been conducted. CariCloud v1.0 is substantially equivalent to the predicate device.
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Image /page/12/Picture/1 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font. Below "Caristo" is the word "diagnostics" in a smaller, light gray font. To the left of the word "Caristo" is a stylized graphic consisting of three concentric arcs in different colors: yellow, orange, and red.
Performance Testing - Inter-operator and Intra-operator Variability
For each device, ICC values were calculated between individual results of each read by each operator on each device for each measure based on an average-rating, absolute-agreement, 2-way mixedeffects model. Theses are shown in the table below.
| PFA | TVOI-A | TVOI-V | TROI-A | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ICC | Reader1 | Reader2 | Reader3 | Reader1 | Reader2 | Reader3 | Reader1 | Reader2 | Reader3 | Reader1 | Reader2 | Reader3 |
| PredicateDevice | 0.999 | 0.998 | 0.999 | 0.986 | 0.983 | 0.985 | 0.988 | 0.991 | 0.973 | 1.0 | 1.0 | 1.0 |
| NewDevice | 0.997 | 0.997 | 0.994 | 0.987 | 0.971 | 0.982 | 0.971 | 0.986 | 0.969 | 1.0 | 0.998 | 1.0 |
Comparison of Intra-Operator Agreement achieved for Each Measure on Each Device:
For all measures, the intra-operator agreement achieved on both the predicate device and the new device for each operator was excellent (ICC greater than 0.96) with a maximum difference in ICC between the two devices was 0.017.
There was no significant difference between the inter-operator variability and intra-operator variability results attained on the two devices.
CONCLUSIONS VII.
CariCloud v1.0 has the same intended use and the same or similar technological characteristics as the predicate device, TeraRecon iNtuition. The minor differences in the indications do not alter the intended use of CariCloud v1.0 and do not raise any new questions of safety or effectiveness. For this reason, CariCloud v1.0 is substantially equivalent to the 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).