Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vasculo-sketal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.

Device Description

Vivid E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, OLED or LCD display monitor (alternatives) and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN adapter) connection.

AI/ML Overview

This document is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vivid E80/Vivid E90/Vivid E95 ultrasound systems. It does not contain detailed information about a study proving the device meets specific acceptance criteria for AI-related features.

The document states:

"The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence."
"Summary of Non-Clinical Tests: Vivid E80 / Vivid E90 / Vivid E95 were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards."

While new AI features are mentioned (AI Auto Measure - 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA, 4D Auto TVQ), the document primarily focuses on demonstrating substantial equivalence to predicate devices based on safety, technological characteristics, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for these AI features.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and adjudication methods for a study proving AI device performance is not available in the provided text.

The only performance metric mentioned related to an AI feature is for "AI Auto Measure - 2D": "This saves time compared to manual measurements, due to elimination of user interactions (clicks) by 79% (4 vs. 19)." However, this is a statement of performance, not an acceptance criterion, and the methodology of that specific evaluation is not detailed.

Without a detailed clinical or performance study presented in the document, it is not possible to fill out the table and answer most of the questions.

However, based on the limited information provided, I can infer the following about what kind of information would be relevant if such a study were present:

Hypothetical Example of Desired Information (Not Found in Document):

If a study were present for the AI Auto Measure - 2D feature, here's what the requested information might look like:

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

Acceptance Criteria Category	Acceptance Criteria (Threshold)	Reported Device Performance (Example)
Accuracy (e.g., PLAX measurements)	Mean absolute difference (MAD) for LV end-diastolic dimension (LVEDD) < 2 mm vs. expert ground truth.	LVEDD MAD = 1.5 mm.
Precision/Reproducibility	Inter-observer variability (Coefficient of Variation) for LV measurements < 5%.	Inter-observer CV = 3.8% (AI-assisted), 7.2% (manual).
Time Savings	Reduction in clicks/manual interactions by > 50%.	79% reduction in user interactions (4 clicks vs. 19 clicks). (This is the only actual metric given)
Clinical Equivalence	No statistically significant difference in diagnostic classification (e.g., normal/abnormal) vs. predicate.	Equivalence demonstrated, 95% agreement with predicate device's manual measurements.

2. Sample size used for the test set and the data provenance:

Hypothetical: Test Set: 500 cardiac ultrasound studies (images/clips).
Hypothetical: Data Provenance: Multi-center retrospective study from hospitals in the US, Europe, and Asia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Hypothetical: 3 board-certified cardiologists with 10+ years of experience in echocardiography.

4. Adjudication method for the test set:

Hypothetical: 2+1 (two experts independently reviewed cases, and a third expert adjudicated disagreements).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Hypothetical: Yes, an MRMC study was performed comparing human performance with and without AI assistance for tasks involving cardiac structure measurements (e.g., LVEDD, LVESV, EF).
Hypothetical Effect Size: Human readers demonstrated a 15% improvement in efficiency (time to read) and a 10% reduction in inter-reader variability when assisted by the AI Auto Measure - 2D feature, primarily due to automated initialization of measurements and reduced manual interactions. The diagnostic accuracy (e.g., agreement with consensus ground truth on disease severity) remained equivalent or showed a slight (e.g., 2%) non-significant improvement with AI assistance.

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

Hypothetical: Yes, standalone algorithm performance was evaluated against the consensus expert ground truth for relevant measurements, achieving a mean absolute error of X for LVEDD and Y for EF.

7. The type of ground truth used:

Hypothetical: Expert consensus measurements by highly experienced cardiologists on the ultrasound images/clips.

8. The sample size for the training set:

Hypothetical: 10,000 cardiac ultrasound studies (images/clips) for AI Auto Measure - 2D.

9. How the ground truth for the training set was established:

Hypothetical: Initial ground truth was established by automated scripts based on existing clinical reports and validated by a team of trained sonographers under the supervision of cardiologists. A subset of the training data (e.g., 10%) was manually annotated and verified by a smaller group of expert cardiologists for quality control and refinement.

Summary

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GE Medical Systems Ultrasound and Primary Care Diagnostics % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K200743

Trade/Device Name: Vivid E80/ Vivid E90/ Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 19, 2020 Received: June 22, 2020

Dear Tracey Ortiz:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

July 23, 2020

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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,

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)

Device Name

Vivid E80 / Vivid E90 / Vivid E95

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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GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	March 20, 2020
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120
Secondary Contact Person:	Jan Tore ThollefsenSr. Regulatory Affairs Manager
Device Trade Name:	Vivid E80 / Vivid E90 / Vivid E95
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class IIIYN (primary), IYO, ITX (secondary)
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Primary Predicate Device:	Vivid E80 / Vivid E90 / Vivid E95 (K181685)
Reference Device(s):	LOGIQ E9 (K163077)
	Vivid E80 / Vivid E90 / Vivid E95 (K170823)Vivid E80 / Vivid E90 / Vivid E95 (K150087)
	Vivid 7 (K051449)
Device Description:	Vivid E80 / Vivid E90 / Vivid E95 is a Track 3, diagnosticultrasound system, which is primarily intended for cardiacimaging and analysis but also includes vascular and generalradiology applications. It is a full featured diagnostic ultrasoundsystem that provides digital acquisition, processing, analysis anddisplay capability.
	The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobileconsole with a height-adjustable control panel, color LCD touchpanel, OLED or LCD display monitor (alternatives) and optionalimage storage and printing devices. It includes a variety of

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GE Healthcare 510(k) Premarket Notification Submission

electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN adapter) connection.

Intended Use: Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular. Musculo-skeletal Conventional. Musculoskeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D. Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. The Vivid E80 / Vivid E90 / Vivid E95 employs the same Technology: fundamental scientific technology as its predicate devices. Determination of Comparison to Predicate Devices Substantial Equivalence: The Vivid E80 / Vivid E90 / Vivid E95 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

The following is an overview of the differences between the proposed Vivid E80 / Vivid E90 / Vivid E95 and its predicates. Transducers and Modes:

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GE Healthcare

510(k) Premarket Notification Submission

Adding the transducer ML6-15-D which was previously ● cleared in LOGIQ E9 (K163077).
Adding the new transducer, 6Vc-D, having the same ● indications as 6S-D previously cleared for Vivid E80 / Vivid E90 / Vivid E95 (K181685). 6Vc-D can be used for 3D and real-time 3D (4D) imaging, similar to 4Vc-D already cleared for Vivid E80 / Vivid E90 / Vivid E95 (K181685).

Indications for Use:

o There are no additional clinical applications, however the statement wording has been modified to align with the new ultrasound guidance.
Features/Functionality additions:
o AI Auto Measure - 2D: AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables automated measurements on a PLAX images using similar process as IMT feature first released on Vivid 7, K051449 and manual workflow on predicate Vivid E95, K150087. This saves time compared to manual measurements, due to elimination of user interactions (clicks) by 79% (4 vs. 19). AI Auto Measure - 2D may also reduce inter-observer variability.
AI Auto Measure Spectrum Recognition: AI based ● Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts the Auto Doppler measurement or opens the appropriate manual measurement folder.
AFI 3.0: based on AFI 2.0 (cleared in Vivid E80/E90/E95, ● K181685), adds the ability to analyze the left ventricle on both GEHC raw data images and DICOM images from 3rd party ultrasound scanners.
Auto EF 3.0: based on Auto EF 2.0 (cleared in K181685), ● adds the ability to assess LV function on raw data images acquired with GEHC scanners as well as on DICOM images from other vendors systems.
AFI RV: based on AFI 2.0 (cleared in K181685) but modified for the right ventricle (RV). It is a parametric tool giving quantitative data for right ventricular longitudinal global strain, free wall strain and segmental strain derived from the apical 4-chamber RV focused view.

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GE Healthcare

510(k) Premarket Notification Submission

AFI LA: based on AFI 2.0 (cleared in K181685) but ● modified for the left atrium. It provides quantitative data for left atrial (LA) global strain. The tool also supports measurements of LA volumes and emptying fraction (EF).
Launchpad: allows the display and launch/starting of third-party software apps that have been installed on the system. Only apps that have been qualified and compatibility verified can be installed on the system.
HD Color: enhances the perception of 4D color on a 2D monitor by addition of shadowing and specular reflection techniques, providing transparency control.
Flexi-Light: enhances the perception of depth of 3D objects when visualized on a 2D monitor by use of advanced shadowing, reflection and shading in combination with depth rendering and use of adjustable virtual light sources.
4D Auto TVQ: new feature for quantification of tricuspid annulus and valve in 4D echocardiographic data. The feature is substantially equivalent to the feature for quantification of the Mitral Valve, 4D Auto MVQ, which is already present on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K170823).
DICOM PDF Read: The system supports read-only access ● to DICOM PDF reports created on a DICOM server.
4D Markers: Feature cleared in Vivid E80/E90/E95 ● (K181685), is modified to allow the user to modify individual markers.
Zscore: Three Z-score sets of values added based on ● published literature - are being added to those previously cleared in Vivid E80/E90/E95 (K181685).

Summary of Non-Clinical Tests:

Vivid E80 / Vivid E90 / Vivid E95 were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. The Vivid E80 / Vivid E90 / Vivid E95 complies with voluntary standards:

o AAMI/ANSI ES60601-1. Medical Electrical Equipment -Part 1: General Requirements for Safety and Essential Performance, 2005/ A2:2012

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue. The logo is simple and recognizable.

GE Healthcare

510(k) Premarket Notification Submission

IEC 60601-1-2, Medical Electrical Equipment Part 1-2: 0 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, 2014
IEC 60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
ISO 10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing Within A Risk Management Process, 2009
IEC 62359, Ultrasonics Field characterization Test ● methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017
ISO 14971, Application of risk management to medical devices. 2007
NEMA PS 3.1 3.20, Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology), 2016

The following quality assurance measures are applied to the development of the system:

Risk Analysis o
Requirements Reviews ●
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification) 0
Performance testing (Verification and Validation) ●
Safety testing (Verification)

Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Vivid E80 /

Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Vivid E80 / Vivid E90 / Vivid E95 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.