LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.

Device Description

The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal short axis (SAX) view. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the LVivo Software Application, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
LVivo EF (Ejection Fraction)	Biplane EF correlation >= 80%	Implicitly met, as stated "similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device." Actual percentage not explicitly given but implied acceptable.
	Similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device (predicate device)	Implicitly met, as described above.
LVivo GLS (Global Longitudinal Strain)	Cutoff value < -17	N/A (Performance metrics like sensitivity/specificity for this cutoff not explicitly provided, only the criteria for comparison).
	Sensitivity >= 75% compared to reference Wall Motion Score Index (WSMI)	Implicitly met, as stated "similar or better results compared to subject device." Actual percentage not explicitly given but implied acceptable.
	Similar or better results compared to subject device (predicate device)	Implicitly met, as described above.
LVivo SWM (Segmental Wall Motion)	Sensitivity >= 75%	Implicitly met, as stated "similar or better results compared to subject device." Actual percentage not explicitly given but implied acceptable.
	Similar or better results compared to subject device (predicate device)	Implicitly met, as described above.

Study Details

Sample Size used for the test set and the data provenance:
- EF Analysis: 96 examinations from a dataset of 100 ambulatory and hospitalized patients.
- SWM and GLS Analysis: 98 examinations from the same dataset of 100 ambulatory and hospitalized patients.
- Data Provenance: Retrospective, collected according to GCP standards from ambulatory and hospitalized patients referred for routine transthoracic echocardiography. The country of origin is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The text mentions "reference WSMI" and comparisons to a "subject device" (likely the predicate device's performance benchmarks), but it does not detail how the initial ground truth for the reference measurements was established.
Adjudication method for the test set:
- This information is not explicitly provided. The text refers to "reference" values but does not describe the adjudication process (e.g., expert consensus) if multiple readers were involved in establishing these reference values.
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:
- A MRMC comparative effectiveness study involving human readers with and without AI assistance was not described in this summary. The study focuses on evaluating the standalone performance of the AI algorithm against established reference values or the predicate device's performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation of the algorithm was performed. The acceptance criteria and "reported device performance" (implicitly met) directly relate to the algorithm's performance on the test set.
The type of ground truth used:
- The ground truth appears to be based on clinically established methods and possibly expert consensus/measurements, as implied by "reference" values and comparison to "reference WSMI." The summary states the data was collected for "routine transthoracic echocardiography," suggesting standard clinical measurements were used as a basis. However, the specific method of establishing this ground truth (e.g., expert manual measurements, pathology) is not explicitly detailed.
The sample size for the training set:
- The sample size for the training set is not provided in the given text. The document describes the test set but offers no details on the data used to train the "neural network" cited as a modification.
How the ground truth for the training set was established:
- This information is not provided in the given text.

Summary

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February 5, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

DiA Imaging Analysis Ltd. % Mr. George J. Hattub Senior Project Manager Medicsense USA 291 Hillside Avenue SOMERSET MA 02726

Re: K210053

Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: OIH Dated: December 31, 2020 Received: January 8, 2021

Dear Mr. Hattub:

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

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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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Indications for Use

510(k) Number (if known) K210053

Device Name LVivo Software Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K210053

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (a)	Submitter Address:	George J. HattubMedicsense USA LLC291 Hillside AvenueSomerset, MA 02726ghattub@comcast.net https://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1
1. (b)	Manufacturer Address:	DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912
	Mfg. Phone:	Tel.: +972 77 7648318
	Contact Person:	Mrs. Michal Yaacobi
	Date:	January 27, 2021
2.	Device &ClassificationName:	Automated Radiological Imaging Processing Software - classified as Class 2QIH, Regulation Number 21 CFR 892.2050LVivo Software Application
3.	Predicate Device:	K200232 LVivo Software Application
4.	Description:	The LVivo platform is a software system for automated analysis ofultrasound examinations. Automated analysis of echocardiographicexaminations is done using DICOM movies. The LVivo platform supportsglobal and segmental evaluation of the left ventricle (LV) of the heart. Theglobal LV function is evaluated from two of the apical views: four-chamber(4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LVfunction is done from three apical views 4CH, 2CH and three chamber(3CH) and supports wall motion evaluation and strain. The LVivo platformsupports also global and segmental evaluation of the LV from theparasternal short axis (SAX) view. In addition to the LV analysis, thecardiology toolbox includes a module for automated evaluation of the RightVentricular function. The LVivo platform includes one additional non-cardiacmodule for the measurement of the bladder volume.
5.	Intended Use:	LVivo platform is intended for non-invasive processing of ultrasound imagesto detect, measure, and calculate relevant medical parameters of structuresand function of patients with suspected disease
6.	Comparison ofTechnologicalCharacteristics:	With respect to technology and intended use, DiA's LVivo SoftwareApplication is substantially equivalent to its predicate device. Based uponthe outcomes from the risk analysis and Performance Testing Evaluation,DiA believes that the modification of the predicate device does not raiseadditional safety of efficacy concerns. The following comparison tabledepicts the changes.

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	Submitted Device	Predicate Device
Features/Characteristics	LVivo SoftwareApplication	LVivo SoftwareApplication
Product Code	same	QIH
Indication for Use	same	LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease.
Modules	same	LVivo EF, LVivo SG,LVivo SAX, LVivo RV &LVivo Bladder
Automation	same	yes
Manual Adjustment	same	yes
Bi plane EF evaluation	same	yes
Simultaneous 2CH and4CH evaluation	same	yes
Off-line EF evaluationusing DICOM clips of anyvendor	same	yes
Automated ED and ESframes selection	same	yes
Dynamic left ventricular	same	yes
Manual editing byuser capability	same	yes
Visually confirm EF	same	yes
Automated rejectionof false results	same	yes
Volume calculation bystandard Simpson'smethod of discs	same	yes
Volume curvePresentation	same	yes
EF results presentation	same	yes
Enables presentation EFresults for differentcycle	same	yes
Algorithm	Modified in LVivo EF	yes
Calculation speed	same	yes
Capability or a part of abigger package (device)for LV function	same	yes
Segmental LongitudinalStrain Measure	same	yes
Global LongitudinalStrain Measure	same	yes
Segmental wall motionevaluation	same	yes
Operating System	same	Windows/Linux(with Androidoption for LVivoEF
510(k) #	Pending	K200232

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510k Notification: LVivo Software Application

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7. Performance A summary of the Performance Evaluation, which was based upon well-Evaluation: established test methods, demonstrated conformity to the intended use.

A data set of 100 ambulatory and hospitalized patients referred for routine transthoracic echocardiography was previously collected according to GCP standards. The population was comprised of 59% male, mean age of 60.6 ±17.727. Inclusion criteria: age >18 in sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 27 patients had normal LV and 47 patients had coronary artery disease (CAD) function. Total of 96 examinations were used for the EF analysis (due to missing ref).

Acceptance criteria for EF analysis: biplane EF correlation >=80%, similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device.

For SWM and GLS analysis, a total of 98 examinations were used from the same data set (due to missing ref).

For GLS acceptance criteria: cutoff value < -17, Sensitivity>=75% compared to ref WSMI, similar or better results compared to subject device

For SWM acceptance criteria: Sensitivity >=75%, similar or better results compared to subject device

1. Conclusion: The Intended Use and the technological characteristics in the current device are the same as those in the predicate device, including the addition of the neural network, do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully support the device performance. Therefore, DiA Imaging Analysis concludes the LVivo Software Application is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).