Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians' diagnosis.

Device Description

The Argus Cognitive ReVISION Software ("ReVISION Software") assesses global and segmental function of the right ventricle (RV) of the heart via the decomposition of longitudinal, radial, and anteroposterior motions of the RV walls and quantifies their relative contribution to global RV ejection fraction along with longitudinal, circumferential and area strains using 3D datasets obtained by echocardiography. Segmentation is performed on the end-diastolic 3D RV model using a rule-based, non-AI/ML algorithm to have 15 RV segments. This segmentation is then projected to all models in the corresponding cardiac cycle.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test (Category)	Acceptance Criteria	Reported Performance
Unit/Integration Testing
Mesh Processing	Mesh orientation parameters for apex, inflow, and outflow centers are within specifications.	Pass
Volume Calculation	Volume calculations are consistent with predicate device and are reproducible.	Pass
Motion Decomposition	Interobserver and intraobserver variability of decomposed end-systolic volumes are within specifications. Pre- and postoperative values for ejection fraction are reproducible.	Pass
Volumetric Segmentation	The relative volumes of each segment to the total volume fall within specifications. The sum of segmental volumes is equal to the global volume. Interobserver and intraobserver variability of segmental end-diastolic and end-systolic volumes are within specifications.	Pass
3D Strain Calculation	Septal and free wall longitudinal strain, and global circumferential strain values are consistent with predicate device. Interobserver and intraobserver reliability of global longitudinal strain are within specifications.	Pass
Verification Tests	Global and segmental metrics are calculated in more than 99% of cases. When inadequate input is presented, the data is not analyzed and an error message is presented. Movement decomposition and volume calculations of known geometric data are accurate.	Pass
Mathematical Unit Tests	The area of a two-dimensional polygon is calculated accurately. The relations between a two-dimensional line or a three-dimensional plane and a point are calculated accurately. The closest point on a line, segment, ray, or plane to a given point is calculated accurately. The distance between two points, a segment and a point, a line and a point, a ray and a point, a plane and a point is calculated accurately. The collinearity of three points or of two lines is calculated accurately. The relation of a point to another point, line, segment, ray, plane, or polygon is calculated accurately. The intersection point of two lines, a line and a triangle, a line and a plane, a ray and a triangle, a ray and a plane is calculated accurately. The intersection of two segments, a segment and a line, a segment and a plane, a segment and a ray, a segment and a triangle is calculated accurately. The points of a polygon are not duplicated and are labeled accurately.	Pass
Evaluation Time	Average evaluation time must be under 15 minutes.	Pass
System Level Testing
Response Time	Response time must be under 10 seconds.	Pass
Response to Stress Conditions	No delay in the ReVISION Software functionality.	Pass
Validation Testing
Accuracy Validation	For segmental metrics: <30% relative difference between ReVISION Software and manual measurements by cardiologists. For global longitudinal and circumferential strains: <10% relative difference between ReVISION Software and manual measurements by cardiologists. For decomposed ejection fractions: 3D model shortens only in the corresponding direction in 100% of cases (visual verification by experts).	Pass
Database Validation	1. ReVISION-derived EDV has a clinically negligible bias compared with TomTec-derived EDV. 2. ReVISION-derived ESV has a clinically negligible bias compared with TomTec-derived ESV. 3. ReVISION-derived SV has a clinically negligible bias compared with TomTec-derived SV. 4. ReVISION-derived EF has a clinically negligible bias compared with TomTec-derived EF. 5. ReVISION-derived global longitudinal strain correlates with TomTec-derived EF. 6. ReVISION-derived global circumferential strain correlates with TomTec-derived EF. 7. ReVISION-derived global area strain correlates with TomTec-derived EF. These evaluations were performed across various populations (entire database, clinical subpopulations, age category subpopulations, RV dysfunction present/absent).	Pass
cMRI Validation	For EDV: ±45 mL absolute difference. For ESV: ±28 mL absolute difference. For EF: ±10 % absolute difference.	Pass
Usability Testing
Usability Evaluation	Acceptable results found no further risks, hazards, or areas for immediate modification after 15 participants completed a usability test focusing on the main elements of ReVISION Software workflow and use errors.	Pass

2. Sample Sizes Used for the Test Set and Data Provenance

Accuracy Validation: 30 subjects (10 healthy adults, 10 adult subjects with established cardiac diseases but maintained right ventricular ejection fraction, and 10 adult subjects with established cardiac diseases and reduced right ventricular ejection fraction).
- Data Provenance: Retrospective, selected from a comprehensive clinical database of 811 subjects with available echocardiographic data. (No specific country of origin is mentioned, but "clinical database" suggests real-world patient data).
Database Validation: 811 subjects.
- Data Provenance: Retrospective 3D echocardiographic clinical database. (No specific country of origin is mentioned).
cMRI Validation: 3 subjects.
- Data Provenance: Retrospective Cardiac Magnetic Resonance Imaging (cMRI) data. (No specific country of origin is mentioned).
Usability Evaluation: 15 participants.
- Data Provenance: Not specified, but generally, usability testing involves representative users in a simulated environment rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Accuracy Validation: 3 expert cardiologists.
- Qualifications: "with expertise in 3D echocardiography."
Database Validation: The comparison was against the predicate device (TomTec-derived values), implying that the predicate acted as a form of ground truth or reference standard for comparison. The document does not describe expert adjudication for these 811 cases beyond the predicate's output.
cMRI Validation: The comparison was against cMRI, which is often considered a gold standard for cardiac imaging. No human expert count or specific qualifications for establishing ground truth from cMRI are mentioned in the context of this validation, as cMRI itself serves as the reference.
Usability Evaluation: Not applicable, as this was a usability test, not an accuracy test requiring medical ground truth.

4. Adjudication Method for the Test Set

Accuracy Validation: The text states, "The cardiologists manually performed segmentation and contouring on the same 3D models that were analyzed by ReVISION Software." This implies an independent assessment by each expert, with the acceptance criteria defining the allowable difference between the device and these manual measurements. There is no explicit mention of an adjudication process (e.g., 2+1, 3+1 consensus) if experts disagreed; it implies each expert's manual measurement was a "ground truth" to be compared against for those specific acceptance criteria. For the visual verification of decomposed ejection fractions, it states "the expert cardiologists' task was to verify visually," again implying individual expert assessment.
Database Validation: No adjudication method mentioned; comparison was directly between device output and predicate device output.
cMRI Validation: No adjudication method mentioned; comparison was directly between device output and cMRI measurements.

5. 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

No such MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned or described in the provided text. The studies focused on the standalone performance and accuracy of the device against manual measurements, predicate device measurements, or cMRI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, extensive standalone performance testing was done.

Unit/Integration Testing, System Level Testing, Accuracy Validation, Database Validation, and cMRI Validation all describe studies where the Argus Cognitive ReVISION Software's output was directly compared against reference standards (manual expert measurements, predicate device output, or cMRI) without a human-in-the-loop scenario explicitly described to modify or interpret the AI's initial output for the purpose of the performance metrics. The device's "accuracy" was assessed independently.

7. The type of ground truth used

The ground truth used varied depending on the validation test:

Expert Consensus/Manual Measurements: For "Accuracy Validation," the ground truth for segmental volumes, EFs, and strains was established by 3 expert cardiologists performing manual segmentation and contouring. For decomposed EFs, it was visual verification by expert cardiologists.
Predicate Device Data: For "Database Validation," the predicate device's calculated parameters (EDV, ESV, SV, EF) served as the reference standard for comparison.
Outcomes Data: Not explicitly mentioned as a ground truth. The focus is on measurement accuracy against established methods.
Pathology: Not mentioned.
cMRI: For "cMRI Validation," Cardiac Magnetic Resonance Imaging (cMRI) measurements were used as a reference for RV volumes and ejection fraction.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop the Argus Cognitive ReVISION Software. The description of the device mentions a "rule-based, non-AI/ML algorithm" for initial segmentation, and while the name "Argus Cognitive" implies AI/ML, the performance testing focuses on the resulting calculations rather than the development or training specifics.

9. How the Ground Truth for the Training Set was Established

Since the document predominantly describes the device's segmentation as "rule-based, non-AI/ML algorithm," the concept of a "training set" and "ground truth for the training set" as typically understood in machine learning might not directly apply in the same way for these core components. For rule-based systems, the "ground truth" during development involves expert-defined rules and specifications, which are then verified through unit and integration testing against known geometric data and clinical cases, as described in the "Mathematical Unit Tests" and "Verification Tests" sections. If there are AI/ML components (which the company name suggests), the process of establishing ground truth for those training sets is not detailed in this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

Argus Cognitive, Inc. % Andrea Marosan Official Correspondent Dartmouth Regional Technical Center 16 Cavendish Court LEBANON NH 03766

June 24, 2023

Re: K223322

Trade/Device Name: Argus Cognitive ReVISION Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 16, 2023 Received: June 16, 2023

Dear Andrea Marosan:

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 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).

Sincerely.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological 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) K223322

Device Name

Argus Cognitive ReVISION Software Application

Indications for Use (Describe)

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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510(k) Notification K223322

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Argus Cognitive, Inc. Dartmouth Regional Technical Center 16 Cavendish Court Lebanon, NH 03766 Phone: 603-400-2440 www.arguscognitive.com

Contact Person:

Attila Meretei President Argus Cognitive, Inc. (603)-400-2440 attila@arguscognitive.com

Date Prepared: June 16, 2023

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Argus Cognitive ReVISION Software Application

Generic/Common Name:

Image review and quantification software

Classification:

21 CFR 892.2050, Medical image management and processing system

Product Code:

LLZ, System, Image Processing, Radiological

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PREDICATE DEVICE(S) [807.92(a)(3)]

K150122 - TomTec-Arena TTA2

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

Please refer to Table 2: Substantial Equivalence Table.

SUBSTANTIAL EQUIVALENCE

The proposed indications for the Argus Cognitive ReVISION Software is substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new or different questions of safety or effectiveness. Thus, the Argus Cognitive ReVISION Software is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(b)]

All necessary software testing was conducted on the Argus Cognitive ReVISION Software to support a determination of substantial equivalence to the predicate device. The testing followed internal company procedures. Software testing was carried out at the module and system levels, following predefined test protocols.

Nonclinical Testing Summary [807.92(b)(1)]:

All necessary performance testing was conducted on the Argus Cognitive ReVISION Software to support a determination of substantial equivalence to the predicate device. Testing acceptance criteria have been predefined in all test protocols to ensure that the subject device is safe and effective. Software verification was performed according to the standard IEC 62304:2005. Medical device software - Software lifecycle processes. Usability testing was performed according to IEC 62366-1:2015. Medical devices – Part 1: Application of usability engineering to medical devices. The collective results of the non-clinical testing demonstrate that the Argus Cognitive ReVISION Software meets the established specifications and complies with the aforementioned standards.

The nonclinical testing is summarized in Table 1: Summary of Testing Performed.

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Test	Acceptance Criteria	Result
Unit/Integration Testing
Mesh Processing	Mesh orientation parameters for apex, inflow, and outflow centers are withinspecifications.	Pass
VolumeCalculation	Volume calculations are consistent with predicate device and are reproducible.	Pass
MotionDecomposition	Interobserver and intraobserver variability of decomposed end-systolicvolumes are within specifications.Pre- and postoperative values for ejection fraction are reproducible.	Pass
VolumetricSegmentation	The relative volumes of each segment to the total volume fall withinspecifications.The sum of segmental volumes is equal to the global volume. Interobserverand intraobserver variability of segmental end-diastolic and end-systolicvolumes are within specifications.	Pass
3D StrainCalculation	Septal and free wall longitudinal strain, and global circumferential strainvalues are consistent with predicate device.Interobserver and intraobserver reliability of global longitudinal strain arewithin specifications.	Pass
Verification Tests	Global and segmental metrics are calculated in more than 99% of cases.When inadequate input is presented, the data is not analyzed and an errormessage is presented.Movement decomposition and volume calculations of known geometric dataare accurate.	Pass
MathematicalUnit Tests	The area of a two-dimensional polygon is calculated accurately.The relations between a two-dimensional line or a three-dimensional plane anda point are calculated accurately.The closest point on a line, segment, ray, or plane to a given point is calculatedaccurately.The distance between two points, a segment and a point, a line and a point, aray and a point, a plane and a point is calculated accurately.The collinearity of three points or of two lines is calculated accurately.The relation of a point to another point, line, segment, ray, plane, or polygon iscalculated accurately.The intersection point of two lines, a line and a triangle, a line and a plane, aray and a triangle, a ray and a plane is calculated accurately.The intersection of two segments, a segment and a line, a segment and a plane,a segment and a ray, a segment and a triangle is calculated accurately.The points of a polygon are not duplicated and are labeled accurately.	Pass
Evaluation Time	Average evaluation time must be under 15 minutes.	Pass
System Leveling Testing
Response Time	Response time must be under 10 seconds.	Pass
Response to StressConditions	No delay in the ReVISION Software functionality.	Pass
Validation Testing
AccuracyValidation	30 subjects (10 healthy adults, 10 adult subjects with established cardiacdiseases but maintained right ventricular ejection fraction, and 10 adultsubjects with established cardiac diseases and reduced right ventricularejection fraction) were randomly selected from a comprehensive clinicaldatabase of 811 retrospective subjects with available echocardiographic data.The accuracy of segmental volumes, EFs, and strains was evaluated by 3expert cardiologists with expertise in 3D echocardiography who was blinded toREVISION Software results. The cardiologists manually performedsegmentation and contouring on the same 3D models that were analyzed byREVISION Software. Acceptance criteria for this validation was <30%relative difference for each of the segmental metrics between the ReVISIONSoftware and the manual measurements performed by the cardiologists.The accuracy of global longitudinal and circumferential strains were alsoevaluated by the expert cardiologists who created longitudinally andcircumferentially oriented contours using manual labeling. Acceptance criteriafor this validation was <10% relative difference in global strain values betweenthe ReVISION Software and the manual measurements performed by thecardiologists.In order to validate that decomposed ejection fractions (LEF, REF, AEF) arecalculated based on such 3D models that are indeed shortened in the givendirection only (i.e., longitudinal, radial, and anteroposterior), we created a testpipeline for expert human readers. By overlaying the decomposed end-systolic3D surface to the end-diastolic 3D surface using the test population's 30 cases,the expert cardiologists' task was to verify visually that the decompositiondirection indeed corresponds to the desired one. Acceptance criterion was thatthe 3D model shortens only in the corresponding direction in 100% of the cases.	Pass
DatabaseValidation	Using the retrospective 3D echocardiographic clinical database of 811subjects, the following parameters were evaluated by the ReVISION Softwareand by the predicate device.Acceptance criteria for this comparison were:1. ReVISION-derived end-diastolic volume (EDV) has a clinicallynegligible bias compared with the TomTec-derived EDV2. ReVISION-derived end-systolic volume (ESV) has a clinicallynegligible bias compared with the TomTec-derived ESV3. ReVISION-derived stroke volume (SV) has a clinically negligiblebias compared with the TomTec-derived SV4. ReVISION-derived ejection fraction (EF) has a clinically negligiblebias compared with the TomTec-derived EF5. ReVISION-derived global longitudinal strain correlates with TomTec-derived EF6. ReVISION-derived global circumferential strain correlates withTomTec-derived EF7. ReVISION-derived global area strain correlates with TomTec-derivedEFThese evaluations were performed in the following populations:A. The entire database (n=811)B. Clinical subpopulations in the database:1. Heart failure patients (n=95)2. Heart transplantation patients (n=86)	Pass
	3. Valvular heart disease patients (n=148)4. Elite athletes (n=137)5. Adult healthy controls (n=191)6. Other adult cardiovascular disease patients (n=50)7. Pediatric renal transplant patients (n=53)8. Pediatric healthy controls (n=51)C. Age category subpopulations:1. Child (2-12 years of age) (n=19)2. Adolescent (12-18) (n=55)3. Transitional adolescent (18-21) (n=79)4. Adult (21+) (n=645)D. Subpopulations based on RV dysfunction present/absent:1. RV dysfunction (n=107)2. No RV dysfunction (n=704)
cMRI Validation	Three (3) subjects with available retrospective Cardiac Magnetic ResonanceImaging (cMRI) were evaluated by ReVISION Software by calculating rightventricular (RV) volumes and ejection fraction (EF).Acceptance criteria for end-diastolic volume (EDV) was ±45 mL absolutedifference.Acceptance criteria for end-systolic volume (ESV) was ±28 mL absolutedifference.Acceptance criteria for ejection fraction (EF) was ±10 % absolute difference.	Pass
Usability Testing
Usability Evaluation	15 participants completed a usability test focusing on the main elements ofReVISION Software workflow and use errors. Acceptable results found nofurther risks, hazards, or areas for immediate modification.	Pass

Table 1: Summary of Testing Performed

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Clinical Testing Summary [807.92(b)(2)]:

No clinical testing was conducted on the Argus Cognitive ReVISION Software to support a determination of substantial equivalence to the predicate device.

CONCLUSIONS [807.92(b)(3)]

Completion of all verification and validation activities demonstrate that the subject device meets all design and performance requirements and is substantially equivalent to the predicate device.

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Table 2: Substantial Equivalence Table
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Feature	Predicate DeviceTomTec-Arena TTA2 4D RV (K150122)	Subject DeviceReVISION Software (K223322)	Rationale for SubstantialEquivalence
K-number	K150122	Not available	Subject of this submission is theReVISION Software.
Regulation Number andRegulation Name	21CFR 892.2050; Medical image management andprocessing system	21CFR 892.2050; Medical image management andprocessing system	Identical to predicate device.
Classification ProductCode	LLZ	LLZ	Identical to predicate device.
Class	2	2	Identical to predicate device.
Classification Panel	Radiology	Radiology	Identical to predicate device.
Device Description	TomTec-Arena TTA2 is a clinical softwarepackage for reviewing, quantifying and reportingdigital medical data. The 4D RV-Function of theTomTec-Arena TTA2 software is a rightventricular (RV) quantification tool for routineclinical work, pulmonary hypertension, and right-sided heart failure. The application helps toovercome complexity of right-ventricle analysis bycalculating standard values based on a semi-automatically generated 3D surface model.	The ReVISION Software assesses global andsegmental function of the right ventricle (RV) ofthe heart via the decomposition of longitudinal,radial, and anteroposterior motions of the RV wallsand quantifies their relative contribution to globalRV ejection fraction along with longitudinal,circumferential and area strains using 3D datasetsobtained by echocardiography.	Similar general device description topredicate device.
Indication for Use	Indications for use of TomTec-Arena software isthe quantification and reporting of cardiovascular,fetal, and abdominal structures and function ofpatients with suspected disease to support thephysicians in the diagnosis.	Indications for use of the Argus CognitiveReVISION Software are quantification andreporting of right ventricle (RV) structures andfunction of patients (adults only) with suspecteddisease to support physicians' diagnosis.	A subset of the predicate device'sintended use.
Site of Use	Hospitals, clinics and physician's offices.	Hospitals, clinics and physician's offices.	Identical to predicate device.
Application Description/ QuantificationTechnology of RV	Software function provides a morphological andfunctional assessment of the right ventricle basedon a surface model of the RV.	Software function provides a morphological andfunctional assessment of the right ventricle basedon a surface model of the RV.	Identical to predicate device.
Intended User Group	TomTec-Arena is intended to be used only bylicensed medical practitioners or assistant medicaltechnicians.	The ReVISION Software is intended to be usedonly by licensed medical practitioners or assistantmedical technicians.	Identical to predicate device.
Feature	Predicate DeviceTomTec-Arena TTA2 4D RV (K150122)	Subject DeviceReVISION Software (K223322)	Rationale for SubstantialEquivalence
Design	Software as a medical device	Software as a medical device	Identical to predicate device.
2D RV calculatedparameters	RVDd base (RVD1): Right Ventricle Distance base (mm) RVDd mid (RVD2): Right Ventricle Distance medial (mm) RVLd (RVD3): Right Ventricle Distance Longitudinal (mm) TAPSE: Tricuspid annular plane systolic excursion (mm) FAC: Fractional area change (%) RVLS (free wall): right ventricular longitudinal strain (free wall) (%) RVLS (Septum): right ventricular longitudinal strain (septum) (%) Global strain TAPSE: MMode measurement for movement of TV between ED and ES RV distance measurements: 3 distance measurements in the RV A4C in ED. RVD1: maximal short-axis dimension in the basal one third of the right ventricle RVD2: distance is measured on 50% of RVLd (RVD3) and parallel to the RVD1 RVD3: base-apex length	None	Only 3D parameters are calculated.
3D RV calculatedparameters	EDV: End-diastolic Volume EDVI: End-diastolic Volume Index ESV: End-systolic Volume ESVI: End-systolic Volume Index SV: Stroke Volume EF: Ejection Fraction	EDV: End-diastolic Volume ESV: End-systolic Volume SV: Stroke Volume EF: Ejection Fraction	Following indexed values are notcalculated: EDVI: End-diastolic Volume Index ESVI: End-systolic Volume Index. These values are raw ones divided byBSA (which can be calculated usingthe patient weight and height).
Feature	Predicate DeviceTomTec-Arena TTA2 4D RV (K150122)	Subject DeviceReVISION Software (K223322)	Rationale for SubstantialEquivalence
3D RV calculatedparameters	EF: Ejection Fraction SV: Stroke Volume	Longitudinal EF Radial EF Anteroposterior EF Global and segmental longitudinal strain Global and segmental circumferential strain Global and segmental area strain	These are the novel measures that theReVISION Software adds on top ofTomTec-derived ones.
Export Formats	Beutel value export into .ucd, .ply or .obj formats	None	No 3D beutel export possibility.The predicate device's output(exported 3D beutel models in .ucdformat) is the input for the SubjectDevice. The subject device analyzesthese models in a more detailedmanner and provides novel measureswithout altering the raw informationcontained by the predicate device'soutput. Thus, these novel features donot raise different questions of safetyand effectiveness but support clinicaldecision making with additionalinformation derived from the rawdata.

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Regulation Number and Section

N/A