LVivo Seamless by DiA Imaging Analysis Ltd

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 and Age >18.

Device Description

The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the LVivo Seamless v2.0 device, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correct identification of 4ch, 2ch, and 3ch views in 90% of the examinations.	The system was able to recognize all three 4CH, 2CH, and 3CH clips in 95% of the examinations. (Meets criterion: 95% > 90%)
Correlation of 80% between GLS by AFI and GLS by LVivo Seamless.	A correlation of 0.88 was reported between GLS by LVivo Strain (running offline on automatically selected clips) and GLS by AFI. (Meets criterion: 0.88 > 0.80) Additionally, a sensitivity of 0.90 and specificity of 0.83 were reported for a Normal/Abnormal GLS threshold of -18%.
Accuracy (Mean ± 1.96STD) for GLS measurement within acceptable ranges (implicitly compared to AFI).	Mean difference for GLS was -1.4% ± 3.93% (LVivo Strain vs. AFI). This metric, while not explicitly given an acceptance threshold, is presented as part of a successful performance evaluation demonstrating conformity to intended use.

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

Sample Size for Test Set: 100 patient examinations.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It mentions "measurements done routinely in the Echo lab by AFI," which suggests retrospective use of existing clinical data.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
It states that "The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI." This implies that the ground truth was established by the "AFI" system (Automated Functional Imaging, GE), which is a commercially available and presumably validated automated measurement tool, as part of routine clinical practice. Since these were routine measurements, they would have been interpreted and validated by qualified medical professionals (e.g., sonographers, cardiologists) in the echo lab. However, the exact process of how the AFI measurements were considered "ground truth" (i.e., whether they were subject to expert review for this study) is not detailed.

4. Adjudication Method for the Test Set

The document does not mention a specific adjudication method (e.g., 2+1, 3+1). The comparison was made between the device's measurements and measurements performed by the AFI system as part of routine lab procedures.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described compares the algorithm's performance against an existing automated system (AFI) for GLS measurements and view identification. It does not evaluate the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The performance evaluation compares the LVivo Seamless v2.0 device's automated capabilities (view recognition and GLS measurement) directly against another automated system (AFI) and against predefined acceptance criteria for view identification. There is no mention of human readers interacting with the device for the purpose of this performance evaluation. The device "runs offline on a server" and "automatically selects the adequate clips for EF and GLS evaluation."

7. The Type of Ground Truth Used

The ground truth for the GLS measurements was established by comparing the LVivo Seamless results to "measurements done routinely in the Echo lab by AFI" (Automated Functional Imaging, GE). For the view identification, the ground truth is implicitly based on the actual presence of 4CH, 2CH, and 3CH views in the patient examinations, likely determined by human assessment during the initial acquisition and processing of the images in the echo lab.

8. The Sample Size for the Training Set

The document does not provide the sample size used for the training set. It focuses solely on the performance evaluation using the test set.

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

The document does not provide information on how the ground truth for the training set was established, as the details of the training process are not included in this summary.

Summary

{0}------------------------------------------------

December 9, 2021

Image /page/0/Picture/1 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

DiA Imaging Analysis Ltd % George Hattub Senior Project Manager Medicsense USA 291 Hillside Avenue SOMERSET, MASSACHUSETTS 02726

Re: K212466

Trade/Device Name: LVivo Seamless v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 8, 2021 Received: November 10, 2021

Dear George 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

{1}------------------------------------------------

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 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 (OS) 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, Division 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}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name DiA LVivo Seamless

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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."

{3}------------------------------------------------

510(k) Summary

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

1. (a)	SubmitterAddress:	George J. HattubMedicsense USA LLC291 Hillside AvenueSomerset, MA 02726ghattub@comcast.net https://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1
1. (b)	ManufacturerAddress:	DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912
	Mfg. Phone:	Tel.: +972 77 7648318
	Contact Person:	Mrs. Michal Yaacobi
	Date:	December 7, 2021
2.	Device &ClassificationName:	Medical Image Management and Processing System -classified as Class 2 QIH, Regulation Number 21 CFR 892.2050LVivo Seamless
3.	Predicate Device:	K202546 LVivo Seamless (Reference Device K210053)
4.	Description:	The LVivo Seamless is a standalone application that extends the LVivoPlatform and runs offline on a server in a healthcare environment. Thesystem accepts echo examinations in DICOM format that are sent from anUltrasound device and automatically selects the adequate clips for EF andGLS evaluation. After the clip selection, the LVivo Seamless activates theFDA cleared LVivo EF and LVivo Strain modules which perform automaticevaluation. The results are sent to the PACS and are evaluated by ahealthcare professional.
5.	Indications forUse:	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 and Age>18
6.	Comparison ofTechnologicalCharacteristics:	With respect to technology and intended use, DiA's LVivo Seamless issubstantially equivalent to its predicate device. Based upon the outcomesfrom the risk analysis and Performance Testing Evaluation, DiA believesthat the modification of the predicate device does not raise additional safetyof efficacy concerns. The following comparison table depicts the changes.
	Submitted Device	Predicate Device	Reference Device
Features/Characteristics	LVivo Seamless	LVivo Seamless	LVivo SoftwareApplication
Product Code	same	QiH	QiH
Indication for Use	DiA's LVivo platform isintended for non-invasiveprocessing of ultrasoundimages to detect,measure, andcalculate relevantmedical parametersof structures andfunction of patients withsuspected disease andAge>18	LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease.	LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease
Modules	LVivo EF, LVivo Strain	LVivo EF	LVivo EF, LVivo SG(LVivo SWM & LVivoStrain), LVivo SAX,LVivo RV and LVivoBladder
Automation	same	yes	yes
Manual Adjustment	same	yes	yes
Bi plane EF evaluation	same	yes	yes
Simultaneous 2CH and4CH evaluation	same	yes	yes
Off-line EF evaluationusing DICOM clips of anyvendor	same	yes	yes
Automated ED and ESframes selection	same	yes	yes
Dynamic left ventricular	same	yes	yes
Manual editing byuser capability	Same, added editingcapabilities to theoutput results	yes	yes



Visually confirm EF	same	yes	yes
Automated rejection offalse results	same	yes	yes
Volume calculation bystandard Simpson'smethod of discs	same	yes	yes
Volume curvecalculation	same	yes	yes
EF results presentation	same	yes	yes
Enables calculation EFresults for differentcycle	same	yes	yes
Algorithm	same	same	yes
Calculation speed	same	yes	yes
Capability or a part of abigger package (device)for LV functionevaluation	same	yes	yes
Segmental LongitudinalStrain Measure	yes	no	yes
Global LongitudinalStrain (GLS) Measure	yes	Yes (from LVivoEF module)	yes
GLS calculation per view	yes	no	no
Operating System	Windows	Windows	Windows/Linux(with Androidoption for LVivoEF)
510(k) #	K212466	K202546	K210053

{4}------------------------------------------------

{5}------------------------------------------------

{6}------------------------------------------------

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

Correct identification of 4ch and 2ch and 3ch views in 90% of the examinations
Correlation of 80% between GLS by AFI and GLS by LVivo Seamless

100 patient examinations were used for the validation. Inclusion criteria: Age>18, examinations in which GLS results by Automated Functional Imaging (AFI .GE) were available. No exclusion criteria were applied. The system was able to recognize all three 4CH, 2CH and 3CH clips in 95% of the examinations. The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI. The GLS by LVivo Strain was compared to GLS by AFI. Statistical analysis was done by Correlation, Bland-Altman:

Measurement	Accuracy(Mean±1.96STD)	Data Range	Correlation
GLS	-1.4% ± 3.93%	-4% - -24%	0.88

sensitivity and specificity and of 0.90, and 0.83 respectively. The Normal\Abnormal threshold used for GLS was -18%

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 GLS Module, 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 Seamless 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).