LVivo IQS 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. In addition, it has the ability to provide Quality Score feedback.

Device Description

The LVivio IQS is an extension to the LVivio IQS (K222970), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Right Ventricle from the 4-chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, is a medical device accessory.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device is an extension to the LVivo IQS (K222970) that provides a Quality Score in real-time to the Right Ventricle (RV) from the 4-chamber apical view of the heart. The acceptance criteria focus on the agreement of the device's quality scoring with expert assessment and the clinical interpretability of images deemed "Medium" or "Good" quality by the device.

Acceptance Criteria	Reported Device Performance
Study 1: Agreement with Sonographer Tagging
Overall agreement of 75% between the LVivo IQS results and the data tagging by experienced sonographers.	The overall agreement between the LVivo IQS (RV) and quality tagging by the experienced sonographers was 77%. (Meets criteria)
Study 2: Real-time Use and Clinical Interpretability
a. 80% of the saved Exams with image quality ACEP score 3-5 received at least "Medium" image quality by LVivo IQS.	In 85% of the patients with image quality 3-5 by visual estimation, it was possible to obtain at least "Medium" quality score by LVivo IQS. (Meets criteria)
b. 90% of these cases (from criteria 'a') were clinically interpretable by the majority of three expert cardiologists specializing in echo.	92% of the above saved clips were clinically interpretable. (Meets criteria)

Study Details

Sample sizes used for the test set and the data provenance:
- Study 1: 100 patient examinations were used for validation. A total of 49,623 frames were analyzed. Data acquisition was done with "different ultrasound devices and various cardiac pathologies." The source country of the data is not explicitly stated, nor is whether the study was retrospective or prospective, though the mention of "already data acquired" suggests a retrospective approach for this specific test.
- Study 2: 182 patients were included in the study. This study involved "data acquired after using the LVivo IQS in real time while scanning the RV from the 4CH apical view." This indicates a prospective data collection directly utilizing the device. The data was gathered in a "Point of Care environment." The country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Study 1: "Experienced sonographer" (singular, though it might imply multiple, the text only states "sonographer"). No specific number or years of experience are provided, but the term "experienced" implies relevant qualifications.
- Study 2: "Three expert cardiologists specializing in echo." No specific years of experience are listed, but "expert" implies high-level qualification in the field.
Adjudication method for the test set:
- Study 1: Not explicitly stated, as it refers to "data tagging by experienced sonographers." This suggests a direct comparison to the sonographer's quality assessment.
- Study 2: For clinical interpretability, the judgment was made "by the majority of three expert cardiologists specializing in echo." This indicates a majority vote (e.g., 2 out of 3 agreement).
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 formal MRMC study comparing human readers with and without AI assistance is not explicitly described. The studies primarily validate the device's standalone performance or its real-time use in conjunction with human actions (Study 2, where doctors documented scores). The studies focus on the device's ability to provide a consistent and clinically relevant quality score, rather than directly measuring reader improvement with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Study 1 serves as a standalone performance evaluation by comparing the device's output to an experienced sonographer's quality tagging on pre-existing data (i.e., the algorithm processes images and outputs a score, which is then compared).
- Study 2 involves the device being used in "real time while scanning," indicating a human-in-the-loop scenario where the device provides feedback during the acquisition process. However, the evaluation of clinical interpretability after the fact (by the expert cardiologists) can be seen as an assessment of the output generated by the combination of the device and the acquisition process it influenced.
The type of ground truth used:
- Study 1: "Quality tagging by experienced sonographers." This is expert consensus/opinion on image quality.
- Study 2:
  - For the device's real-time quality score (criteria 'a'), the ground truth was the "visual estimation" via "ACEP score (1-5)" made by the medical doctors during acquisition. This represents user-reported quality.
  - For clinical interpretability (criteria 'b'), the ground truth was "clinically interpretable by the majority of three expert cardiologists specializing in echo." This is expert clinical interpretation/consensus.
The sample size for the training set:
- The document does not specify the sample size for the training set. It only describes the validation/test sets.
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. It only discusses the ground truth for the validation/test sets. The algorithm is described as "AI based," which implies a training phase, but details are omitted.

Summary

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DiA Imaging Analysis Ltd. % George Hattub Medical Device Regulatory Affairs Specialist Medicsense USA LLC 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K240769

May 24, 2024

Trade/Device Name: LVivo IOS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: May 3, 2024 Received: May 3, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)
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K240769

Device Name

LVivo IQS

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) 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
1. (b)	ManufacturerAddress:	DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912
	Mfg. Phone:	Tel.: +972 77 7648318
	Contact Person:	Mrs. Michal Yaacobi
	Date:	March 19, 2024
2.	Device &ClassificationName:	Medical Image Management and Processing System -classified as Class 2 QIH, Regulation Number 21 CFR 892.2050LVivo IQS
3.	Predicate Devices:	LVivo IQS K222970
4.	Description:	The LVivio IQS is an extension to the LVivio IQS (K222970), as anadditional Algorithm with API that will be able to provide a Quality Score inreal time to the Right Ventricle from the 4-chamber apical view of the heart.In addition, the LVivo IQS will be provided as a software component to beintegrated by another computer programmer into their legally marketedultrasound imaging device. Essentially, the Algorithm and API, which is amodule, is a medical device accessory.
5.	Indications forUse:	LVivo platform is intended for non-invasive processing of ultrasoundimages to detect, measure, and calculate relevant medical parameters ofstructures and function of patients with suspected disease. In addition, it hasthe ability to provide Quality Score feedback.
6.	Comparison ofTechnologicalCharacteristics:	With respect to technology and intended use, DiA's LVivo IQS issubstantially equivalent to its predicate device. Based upon the outcomesfrom the risk analysis and Performance Testing Evaluation, DiA believesthat the incremental extension of the LVivo IQS module to the LVivo IQSpredicate device does not raise additional safety of efficacy concerns. Thefollowing comparison table depicts the changes.

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#	Features/ Characteristics	Submitted Device	Predicate DeviceK222970
		LVivo IQS	LVivo IQS
1	Indication for Use	Same	LVivo platform isintended for non-invasive processingof ultrasoundimages to detect,measure, andcalculate relevantmedical parameters ofstructures andfunction of patientswith suspecteddisease. In addition, itprovides Quality IndexScore Feedback.
2	Product Code	Same	QIH
3	LVivo IQS Module	LVivo IQS for LV from 4-Chamber ViewLVivo IQS for RV from 4-Chamber View	LVivo IQS for LV from 4-Chamber View
4	Operating System	Same	Ram: 8 GBWindows 10 or higherProcessor: Intel core i3compatible or higher
5	Automated IQS	Same	Yes
6	Algorithm	AI based	AI Based
7	Grading system ranges	Same	0-60% poor (red),60-80 % medium (orange)80-100 % good (green)
8	I/O support through API	yes	yes
9	User group	same	same
10	510(k) #	K240769	K222970

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

The performance of the LVivo IQS system was validated using already data acquired with different ultrasound devices and various cardiac pathologies, compared to quality tagging by experienced sonographer.

Success criteria:

Overall agreement of 75% between the LVivo IQS results and the data tagging by experienced sonographers

100 patient examinations were used for the validation. Inclusion criteria: Age>18, patients referred to routine Echo examination. Exclusion criteria: Subjects who fail to meet any inclusion criteria. A total of 49,623 frames were analvzed.

The overall agreement was agreement between the LVivo IQS (RV) and quality tagging by the experienced sonographers was 77%

The performance of the LVivo IQS system was validated using data acquired after using the LVivo IQS in real time while scanning the RV from the 4CH apical view. The scans were acquired in the Point of Care environment by medical doctors in their internship. The obtained quality score was documented before saving the clip. The ACEP score (1-5) and the obtained quality score by LVivo IQS were documented.

Success criteria: a. 80% of the saved Exams with image quality ACEP score 3-5. received at least "Medium" image quality by LVivo IQS, b. 90% of these cases were clinically interpretable by the majority of three expert cardiologists specializing in echo.

182 patients were included in the study and the saved scans were analyzed. Inclusion criteria: Age >18, indication for POCUS, Exclusion criteria: subjects who fail to meet any inclusion criteria. The results are summarized in Table-1:

End point number	Results
a.	In 85% of the patients with image quality 3-5by visual estimation it was possible to obtainat least "Medium” quality score by LVivo IQS
b.	92% of the above saved clips were clinicallyinterpretable

Table-1: Results summary

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1. Conclusion: The Intended Use and the technological characteristics of the subject device are the same as those in the LVivo IQS predicate device, and do not affect the safety and effectiveness of the device. The performance testing has been completed and has successfully verifed the performance of the device. Therefore, DiA Imaging Analysis concludes the LVivo IQS 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).