Yes
The document explicitly mentions "testing of the AI algorithm" and provides details about the test set and performance metrics (accuracy/dice score) for this algorithm.
No.
The device is described as a "diagnostic ultrasound system" and is intended for "ultrasound imaging, measurement, display and analysis." Its intended uses are for diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services." The "Device Description" also refers to it as a "diagnostic ultrasound device."
No
The device description explicitly states it consists of a compact console with control panel, color LCD Touch Panel, optional cart, integrated battery, and utilizes various electronic array transducers. These are all hardware components.
Based on the provided information, the Vivid iq 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 a device that interacts with the patient directly to produce images and measurements, not a device that analyzes samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description details an ultrasound system with transducers, a console, and image processing capabilities. This aligns with an in vivo imaging device, not an in vitro diagnostic device.
- Anatomical Sites: The listed anatomical sites are all parts of the human body that are imaged directly.
- Input Imaging Modality: The input modality is Ultrasound, which is an in vivo imaging technique.
In vitro diagnostics are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Vivid iq performs imaging and analysis within the body, making it an in vivo diagnostic device.
No
The input document does not contain any explicit statement that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
Product codes
IYN, IYO, ITX
Device Description
The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time. There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes 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 can also be used with compatible ICE transducers. The system includes electronics for transmit and receive of 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 USB-adapter) connection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes - "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)", "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."
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal.
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal. Specific age unknown for AI testing.
Intended User / Care Setting
Qualified and trained Healthcare professionals. Intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found. "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."
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 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 Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 iq, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average dice score >= 92% (on datasets from different countries, different LV volumes); average dice score >= 91% (on datasets from different scanning views).
Predicate Device(s)
Vivid iq (K200708)
Reference Device(s)
Vivid E95 (K173341), Venue Go (K202233), Versana Premier (K210438)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 18, 2022
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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K221148
Trade/Device Name: Vivid iq Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 1, 2022 Received: July 5, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has decorative, swirling elements around the letters, giving it a classic and recognizable appearance.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2023 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K221148 |
| Device Name | Vivid iq |
| Indications for Use (Describe) | The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. |
| It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human | |
| body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ | |
| (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral | |
| Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, | |
| Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, | |
| Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, | |
| Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and | |
| Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is | |
| intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab | |
| and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities. | |
| 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) |
| 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." |
EF PSC Publishing Services (301) 443-6740
3
Image /page/3/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 blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 12, 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: | Yuan Wang |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Device Trade Name: | Vivid iq |
| 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 | |
| Predicate Device: | Vivid iq (K200708), 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 (K173341), 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 Go (K202233), 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 |
4
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, and the circle has a wavy border.
Reference Device: Classification Names: Product Code(s): Class II 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
Device Description:
The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time.
There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes 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 can also be used with compatible ICE transducers.
The system includes electronics for transmit and receive of 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 USB-adapter) connection.
Intended Use/Indication For Use:
The Vivid ig is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid ig clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transveginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
Technology:
The Vivid iq employs the same fundamental scientific technology as its predicate device.
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is colored in a light blue hue, and the background is white.
GE Healthcare
510(k) Premarket Notification Submission
Determination of Substantial Equivalence:
The proposed Vivid ig system is substantially equivalent to the predicate device Vivid ig and reference devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
The following is an overview of the differences between the proposed Vivid iq and its predicate device.
Indications for use:
The proposed Vivid ig and predicate Vivid ig (K200708) have similar clinical indications for use, except for:
- Added Thoracic/Pleural application, which was cleared on reference device Venue Go (K202233). ●
- . Urology (Including prostate) is listed independently instead of within Abdominal as it was in the predicate Vivid iq (K200708). There is no change in imaging or the product. No impact to safe or effective use.
Transducer and modes:
- The proposed Vivid iq and predicate Vivid ig (K200708) have identical imaging modes. ●
- The proposed Vivid ig and predicate Vivid iq (K200708) transducers are similar, except for: .
- Addition of 10T-D, which was first cleared on Vivid E95 (K173341). The clinical applications O and imaging modes of 10T-D are similar on the proposed Vivid iq as they are on the reference device Vivid E95 (K173341).
- o Addition of L4-20t-RS, which was first cleared on Venue Go (K202233). The clinical applications and imaging modes of L4-20t-RS are similar on the proposed Vivid iq as they are on the reference device Venue Go (K202233).
- The Thoracic/Pleural application is added to the transducers: ●
- 3Sc-RS.6S-RS, 9L-RS, 12L-RS, ML6-15-RS, L8-18i-RS, C1-5-RS, 8C-RS, and L4-20t-RS o based on the clearance of reference device Venue Go (K202233).
- 4C-RS based on the clearance of reference device Versana Premier (K210438). O
- 12S-RS is a similar transducer to 6S-RS cleared with reference device Venue Go (K202233) O
- M5Sc-RS is a similar transducer to 3Sc-RS cleared with reference device Venue Go (K202233) O
Software:
- Added workflow enhancements tools: Dual Crop, Pre-Post Compare, Image Spooler
- Updates made to: 2D Color Flow, Flexi-Slice, Launchpad ●
- 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, circumference, and volume measurement method ●
- Added Strain Elastography feature added, cleared in Versana Premier (K210438) ●
- Added Imaging Insights Data Collection Support - provides device usage information
- Added Probe check (Transducer Element Check) ●
Accessories:
- Added compatible OEM biopsy guide accessory compatibility for the L4-20t-RS transducer ●
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has a decorative border, giving it a classic and recognizable appearance.
GE Healthcare
510(k) Premarket Notification Submission
Vivid iq is 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 ig 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 materials 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
Demographic distribution including:
- Gender: Unknown, due to data anonymization during data collection
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable appearance.
- 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 iq, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the Vivid ig to be as safe, as effective, and performance is substantially equivalent to the predicate and reference devices.