(107 days)
Not Found
No
The summary describes image processing and quantitative analysis but does not mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development (training/test sets).
No
The device assists in diagnosis by processing images but does not actively treat or alleviate a disease, nor does it restore or modify the body's structure or functions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis." This directly indicates that the device is intended for diagnostic purposes.
Yes
The device description explicitly states "CariCloud is an image processing prescription software device". While it processes previously acquired CT images, the device itself is described solely as software.
Based on the provided information, CariCloud is likely not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. CariCloud analyzes previously acquired CT images, which are not biological specimens.
- IVDs are typically used to provide information about a physiological state, health, or disease. While CariCloud's results may assist in diagnosis, its primary function is image processing and quantification of anatomical structures (coronary arteries and surrounding tissue) from medical images.
- The description focuses on image processing, manipulation, and quantification of existing medical images. This aligns more with medical image analysis software than with an IVD.
- The performance study focuses on inter-operator and intra-operator variability in image analysis, not on the accuracy of diagnosing a specific condition based on a biological sample.
While the results of CariCloud's analysis are used by Healthcare Professionals and may assist in diagnosis, this is a common characteristic of many medical devices that are not IVDs. The key distinction lies in the type of input (medical images vs. biological specimens) and the primary function (image analysis vs. examination of biological samples for diagnostic information).
Therefore, based on the provided description, CariCloud falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
coronary arteries and surrounding tissue
Indicated Patient Age Range
all patients
Intended User / Care Setting
trained operators; Healthcare Professionals
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided. The software level of concern for CariCloud v1.0 is Moderate. A risk analysis was performed. Cybersecurity and data security testing has been conducted.
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 mixed-effects model. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ICC (Intraclass Correlation Coefficient) values for Inter-operator and Intra-operator Variability:
Predicate Device: PFA (0.999, 0.998, 0.999), TVOI-A (0.986, 0.983, 0.985), TVOI-V (0.988, 0.991, 0.973), TROI-A (1.0, 1.0, 1.0)
New Device: PFA (0.997, 0.997, 0.994), TVOI-A (0.987, 0.971, 0.982), TVOI-V (0.971, 0.986, 0.969), TROI-A (1.0, 0.998, 1.0)
Predicate Device(s)
TeraRecon iNtuition, K121916
Reference Device(s)
Not Found
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
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
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
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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 |
| Product | |||
| Code | LLZ | LLZ | Same |
| Regulation | |||
| Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Intended Use | |||
| / Indications | |||
| for Use | 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. | To receive, store, transmit, | ||
| post-process, display and | |||
| allow manipulation of reports | |||
| and medical images from | |||
| acquisition devices, including | |||
| optical or other non-DICOM | |||
| format images, DICOM | |||
| images with modality type XA, | |||
| US, CR, DR, SPECT, NM and | |||
| MG, and images from | |||
| volumetric medical scanning | |||
| devices such as EBT, CT, | |||
| PET or MRI. | |||
| To provide access to images | |||
| derived data and derived | |||
| images via client-server | |||
| software, web browser and | |||
| mobile technology. | |||
| Visualization in 2D, 3D and | |||
| 4D are supported for single or | |||
| multiple datasets, or | |||
| combinations thereof | |||
| Tools are provided to define | |||
| and edit paths through | |||
| structures such as centerlines, | |||
| which may be used to analyze | |||
| cross-sections of structures, or | |||
| to provide flythrough | |||
| visualizations rendered along | |||
| such a centerline | CariCloud and TeraRecon's | ||
| iNtuition device can both be | |||
| used to evaluate attenuation | |||
| in the coronary arteries and | |||
| surrounding tissue in CT | |||
| images. | |||
| CariCloud and | |||
| TeraRecon's iNtuition | |||
| device differ in that iNtuition | |||
| has additional features and | |||
| supports use in evaluating | |||
| images from other | |||
| modalities and diagnostic | |||
| areas such as oncology and | |||
| neurology. | |||
| The fact that TeraRecon's | |||
| iNtuition device supports | |||
| additional modalities and | |||
| diagnostic areas does not | |||
| affect the safety and | |||
| effectiveness of CariCloud | |||
| because the additional | |||
| functionality offered by | |||
| iNtuition is unrelated to the | |||
| safety and effectiveness of | |||
| CCTA 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 of | ||||||
| mammographic images or | ||||||
| digitized film screen images is | ||||||
| supported only when the | ||||||
| software is used without | ||||||
| compression and with an FDA- | ||||||
| Approved monitor that offers | ||||||
| at least SMpixel resolution and | ||||||
| meets other technical | ||||||
| specifications reviewed and | ||||||
| accepted by the FDA. |
iNtuitionMOBILE provides
wireless and portable access
to medical images. This device
is not intended to replace full
workstations and should be
used only when there is no
access to a workstation. Not
intended for diagnostic use
when used via a web browser
or
mobile device.
iNtuition will be marketed as a
software only solution for the
end-user (with recommended
hardware requirements) or as
a complete workstation for the
end user (software package
with harware kit). | | | | |
| | | | | | Technical Characteristics | |
| | | Data Type | | - CT
- 3D Medical Image Review | - CT, MR, Nuc, PET, Angio,
US/Echo, SPECT, CR/DR
Review | CariCloud supports CT
review. This difference does
not affect the safety of the
device. |
| | | | | | - 2D, 3D, 4D Medical Image
review including cine play | |
| Input Patient
Data | - Manual through
keyboard/mouse | - Manual through
keyboard/mouse | The same as the predicate
device. | | | |
| | - Command line interface. | - Command line interface | | | | |
| Study list
functionality | - Search | - Importing - Exporting
- Deleting
- Search | CariCloud does not support
import, export, delete and
anonymization. This
difference does not affect
the 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 |
|---|---|---|---|
| Centerline | |||
| Extraction | - Automatic and manual | ||
| centerlines | - Automatic and manual | ||
| centerlines | The same as the predicate | ||
| device. | |||
| - Centerline edits and | |||
| refinements. | - Centerline edits and | ||
| refinements. | |||
| - Vessel Analysis | - Vessel Analysis | ||
| - Automatic and manual | |||
| segmentation of structures |
- Segmentation editing | - Automatic and manual
segmentation of structures - Segmentation editing | |
| Image
Assessment | - Linear (length, diameter),
distance and ROI
measurements | - Linear (length, diameter,
perimeter), distance pair,
angular and ROI
measurements | CariCloud supports a sub-
set of the image
assessment tools that are in
the predicate device. This
does not affect the safety of
the device. |
| | - Area measurements | - Area measurements | |
| | - Volume measurements
including VOI and
thresholding | - Volume measurements
including volumetric
histogram, VOI and TVA for
Time Volume Analysis for
heart chamber segmentation
and analysis | |
| | - Segmentation and analysis
of coronary artery tree
centerline | - C-arm angulation calculation | |
| | - Synchronized side-by-side
review | - Text and arrow annotations | |
| | - Synchronized center of
rotation viewing | - Anatomy ID (Landmark Label
Selection) | |
| | | - Calcium scoring for
assessment of calcium in the
aortic root | |
| | | - Calcium scoring for
assessment of calcium in the
coronary arteries - Segmentation and analysis
of coronary artery tree
centerline - Synchronized side-by-side
review - Synchronized center of
rotation 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 for | |||
| temporal correlative analysis | |||
| 2D/3D Batch movie tool and | |||
| export |
- 2D/3D Batch movie tool and
export | |
| Image
Assessment
Rendering | - MPR - 3D triangulation
- Curved Planar Reformat
(CPR) - Synchronized side-by- side
viewing - Synchronized center of
rotation viewing - Multi-Mask Display (multi-
object display) - Editing tools: free- hand | - 2D/3D Batch movie tool and
export - MIP , MPR, MinIP ,
- Raysum (ThickMPR)
- 3D triangulation
- Perspective endoluminal
view - Medial Axial Reformat (MAR)
- Curved Planar Reformat
(CPR) - Double-oblique MIP and
MPR - Image enhancement filters
- Synchronized side-by- side
viewing - Synchronized center of | CariCloud supports a sub-
set of the image
assessment rendering tools
that are in the predicate
device. This does not affect
the 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 measurement
protocols - Editing tools: crop, cut, free-hand | |
| Storage of
results | DICOM SC | - Structured reporting with xml,
text, xls output - Word and html report
- DICOM SC
- Workflow scenes: restore
saved state | CariCloud supports a sub-
set of the result storage
tools that are in the
predicate device. This does
not affect the safety of the
device. |
| Conferencing
and
Collaboration | Not supported. | Conferencing and
Collaboration | Not supported. This does
not affect the safety of the
device. |
| Operating
System | Any operating system that
supports the Chrome
Browser. | Microsoft Windows | CariCloud is supported on
the Chrome Browser. This
does not affect the safety of
the 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 | Reader | |||||||||||
| 1 | Reader | |||||||||||
| 2 | Reader | |||||||||||
| 3 | Reader | |||||||||||
| 1 | Reader | |||||||||||
| 2 | Reader | |||||||||||
| 3 | Reader | |||||||||||
| 1 | Reader | |||||||||||
| 2 | Reader | |||||||||||
| 3 | Reader | |||||||||||
| 1 | Reader | |||||||||||
| 2 | Reader | |||||||||||
| 3 | ||||||||||||
| Predicate | ||||||||||||
| Device | 0.999 | 0.998 | 0.999 | 0.986 | 0.983 | 0.985 | 0.988 | 0.991 | 0.973 | 1.0 | 1.0 | 1.0 |
| New | ||||||||||||
| Device | 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.