(119 days)
Vivid E95 (K202658)
Yes
The summary explicitly mentions "AI Summary of Testing" and describes the testing of an "AI algorithm" for "Easy Auto EF and Easy AFI LV".
No.
The device is a diagnostic ultrasound system intended for imaging, measurement, display, and analysis of the human body and fluid, not for therapy.
Yes
The "Device Description" explicitly states, "Vivid™ E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system." The "Intended Use / Indications for Use" also describes its use for "ultrasound imaging, measurement, display and analysis," which are components of diagnostic procedures.
No
The device description clearly states it is a "full featured diagnostic ultrasound system" consisting of a "mobile console with a height-adjustable control panel, color LCD touch panel, and display monitor" and includes "electronic array transducers". These are hardware components, not just software.
Based on the provided information, the Vivid E80/Vivid E90/Vivid E95 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
- Device Description: The description details an ultrasound system with transducers, a console, and image processing capabilities. This aligns with an in vivo imaging device.
- Anatomical Site: The listed anatomical sites are all parts of the human body, which are examined in vivo.
- Input Imaging Modality: Ultrasound is an in vivo imaging modality.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform such analysis.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for 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, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal Guidance (including Biopsy, Vascular Access), ThoracicPleural and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D (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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
Vivid™ E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, 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 capabilities.
The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and display monitor. 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 transducers. System can also be used with compatible ICE transducer.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. The system includes capability to output data to other devices like printing devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, ThoracicPleural
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained physician, hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found (inference: description of training set is not provided, only independence of test data).
Description of the test set, sample size, data source, and annotation protocol
The number of individual patients' images were collected from: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization of dataset).
The number of samples, if different from above, and the relationship between the two: 135 images extracted from the 45 exams.
Demographic distribution:
- Gender: Unknown, due to data anonymization during data collection
- Age: Adult, specific age unknown
- Ethnicity/Country: Europe, Asia, US .
Information about clinical subgroups and confounders present in the dataset: During testing of the AI algorithm, we have included images from different countries, from different scanning views, and a range of different LV Volumes.
Information about equipment and protocols used to collect images: Mix of data from across 5 different probes and 4 different Console variants. The data collection protocol was standardized across all data collection sites.
Information about how the reference standard was derived from the dataset (i.e., the "truthing" process): For all datasets, two certified cardiologists performed manual delineation, then reviewed the annotations for each other. A consensus reading was first done whereby the two cardiologists discussed if they agreed on or not. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on. Hence, the ground truth used are the annotations that the two cardiologists agreed with each other, and the consensus annotations achieved in the review meeting by a panel of experienced experts.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
AI Summary of Testing: Easy Auto EF and Easy AFI LV
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance
- The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher; as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.
The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (average dice score) >= 91%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Vivid E95 (K202658)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
LOGIQ E10 (K211488), Venue (K202132), Vivid E95 (K181685), Collaboration Live (K200179), Customer Remote Console (CRC) (K150193)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
July 22, 2022
Image /page/0/Picture/1 description: The image shows the logo for 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 acronym and name on the right. The FDA part of the logo is in blue and includes the words "U.S. FOOD & DRUG ADMINISTRATION".
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Lee Bush Regulatory Affairs Director Primary Care Diagnostics, LLC 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K220882
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 23, 2022 Received: June 24, 2022
Dear Lee Bush:
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
1
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,
For
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K220882
Device Name
Vivid E80 / Vivid E90 / Vivid E95
Indications for Use (Describe)
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, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal Guidance (including Biopsy, Vascular Access), ThoracicPleural and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D (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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets or waves. The logo is simple and recognizable, and it is associated with a well-known and established company.
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 14, 2022 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Lee Bush |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262) 309-9429 | |
| Secondary Contact Person: | Jan Tore Thollefsen |
| Sr. Regulatory Affairs Manager | |
| GE Healthcare | |
| Device Trade Name: | Vivid E80 / Vivid E90 / Vivid E95 |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Primary Predicate Device: | Vivid E95 (K202658), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three water droplet-like shapes evenly spaced around the inside of the circle, adding a dynamic element to the design. The logo is simple, recognizable, and represents the brand identity of General Electric. The blue color is consistent throughout the logo.
510(k) Premarket Notification Submission
| Reference Device: | LOGIQ E10 (K211488), Diagnostic Ultrasound System |
|---|---|
| Classification Names: | Class II |
| Product Code(s): | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Reference Device: | Venue (K202132), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX; | |
| Reference Device: | Vivid E95 (K181685), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN; |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX; | |
| Reference Device: | Collaboration Live (K200179), Picture archiving and communications |
| system | |
| Classification Names: | Class II |
| Product Code(s): | Picture archiving and communications system, 21 CFR 892.2050, LLZ |
| Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Reference Device: | Customer Remote Console (CRC) (K150193), Picture archiving and |
| communications system | |
| Classification Names: | Class II |
| Product Code(s): | Picture archiving and communications system, 21 CFR 892.2050, LLZ |
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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are four white teardrop shapes around the circle, one at each cardinal direction. The logo is simple and recognizable, and it is associated with a well-known and established company.
510(k) Premarket Notification Submission
Device Description:
Vivid™ E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, 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 capabilities.
The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and display monitor. 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 transducers. System can also be used with compatible ICE transducer.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. The system includes capability to output data to other devices like printing devices.
Intended Use/Indication for 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, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intracardiac and Intra-luminal. Interventional Guidance (including Biopsv. Vascular Access). Thoracic/Pleural and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D (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.
Technology:
The Vivid E80 / Vivid E90 / Vivid E95 employs the same fundamental scientific technology as its predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are four white swirls around the outside of the circle, one in each quadrant. The logo is simple and recognizable.
Determination of Substantial Equivalence:
The proposed Vivid E80 / Vivid E90 / Vivid E95 system is substantially equivalent to the predicate Vivid E95 and reference devices with regards to intended use, indications for use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness.
The following is an overview of the differences between the proposed Vivid E80 / Vivid E90 / Vivid E95 and its predicate and reference devices.
Indications for use:
- Added Thoracic/Pleural application based on reference device, Venue ● (K202132)
Transducer:
- Added 9VT-D for Realtime 3D(4D) TEE imaging
Software:
- Added workflow enhancements tools: Dual Crop, Pre-Post Compare
- Updates made to: 2D Color Flow, 4D Color Flow, Flexi-Slice, 4D Markers, ● Auto Tissue, Image Spooler, Launchpad, 4D Auto LVQ, and 4D Auto TVQ
- . Added cSound™ Adapt- substantially equivalent to Adaptive Contrast Enhancement cleared in predicate Vivid E95 (K202658)
- Added CT Fusion Live- based on CT Fusion cleared in predicate Vivid E95 ● (K202658)
- Added Image View main monitor image duplicated on the touch screen ●
- Added Easy Auto EF -based on Auto EF 3.0 (includes AI Auto ROI algorithm) ●
- Added Easy AFI LV -based on AFI 3.0 (includes AI Auto ROI algorithm) ●
- Added Spline Tool -area measurement method
- Added Strain Elastography feature added, cleared in LOGIQ E10 (K211488)
- Added Imaging Insights Data Collection Support provides device usage ● information
- Added Remote Viewing -enables streaming of the main monitor over the local network. This feature is not intended for diagnostic use
- Added Probe Check (transducer element check) ●
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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' intertwined in a stylized script, enclosed within a circular border. There are decorative flourishes resembling water droplets or stylized leaves surrounding the central 'GE' monogram. The logo is presented in a light blue color.
Summary of Non-Clinical Tests:
Vivid E80 / Vivid E90 / Vivid E95 was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Vivid E80 / Vivid E90 / Vivid E95 complies with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: General Requirements ● for Safety and Essential Performance, 2005/ A2:2012
- . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: 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, Ed. 2.1, 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, 2019
- . 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 ●
- Requirements Reviews ●
- Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- Performance testing (Verification) ●
- Safety testing (Verification) ●
Transducer material and other patient contact materials are biocompatible.
AI Summary of Testing: Easy Auto EF and Easy AFI LV
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance
- The accuracy of the AI algorithm (average dice score) as tested on datasets from different ● countries, is 92% or higher; as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.
- The number of individual patients' images were collected from: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization of dataset).
- The number of samples, if different from above, and the relationship between the two: ● 135 images extracted from the 45 exams
8
Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "ge" in a stylized font in the center. There are three water droplet shapes around the outside of the circle. The logo is simple and recognizable, and it is associated with a well-known company.
GE Healthcare 510(k) Premarket Notification Submission
Demographic distribution including:
- Gender: Unknown, due to data anonymization during data collection
- Age: Adult, specific age unknown
- Ethnicity/Country: Europe, Asia, US .
Information about clinical subgroups and confounders present in the dataset:
-
. During testing of the AI algorithm, we have included images from different countries, from different scanning views, and a range of different LV Volumes
Information about equipment and protocols used to collect images: -
Mix of data from across 5 different probes and 4 different Console variants. The data ● collection protocol was standardized across all data collection sites.
Information about how the reference standard was derived from the dataset (i.e., the "truthing" process) -
. For all datasets, two certified cardiologists performed manual delineation, then reviewed the annotations for each other. A consensus reading was first done whereby the two cardiologists discussed if they agreed on or not. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
-
Hence, the ground truth used are the annotations that the two cardiologists agreed with ● each other, and the consensus annotations achieved in the review meeting by a panel of experienced experts.
Description of how independence of test data from training data was ensured.
- To ensure that the testing dataset is not mixed with the training data, we used datasets from different clinical sites for testing as compared to the clinical sites for training.
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 E90 / Vivid E90 / Vivid E95 to be as safe, as effective, and performance is substantially equivalent to the predicate and reference devices.