(125 days)
Yes
The document explicitly mentions "AI Testing Summary" and describes the testing and performance of features like "Auto Renal Measure Assistant", "Auto Abdominal Color Assistant", and "Auto Preset Assistant", which are stated to use AI. It also mentions creating a "confusion matrix of ground truth vs AI predictions".
No
The document states that the devices are "general purpose diagnostic ultrasound system[s]" and lists various clinical applications for "ultrasound evaluation," indicating its use for diagnosis rather than treatment.
Yes
The device description explicitly states, "The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system," and similarly for the LOGIQ Fortis. The stated "Intended Use / Indications for Use" also lists various clinical applications, all of which involve medical diagnosis.
No
The device description clearly states it is a "full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console" with physical components like a keyboard, touch screen, and monitor. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "ultrasound evaluation" by a qualified physician for various clinical applications and exam types. This involves imaging the internal structures of the body using ultrasound waves.
- Device Description: The device is described as a "general purpose diagnostic ultrasound system" that provides "digital acquisition, processing and display capability." This aligns with the function of an ultrasound machine, which generates images from sound waves.
- Input Imaging Modality: The input modality is explicitly stated as "Ultrasound."
- Anatomical Site: The listed anatomical sites are all internal or external parts of the human body that are imaged using ultrasound.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues, taken from the human body, to detect diseases, conditions, or infections.
This device does not perform tests on samples taken from the body. It uses ultrasound technology to create images of the body's internal structures for diagnostic purposes. While it uses AI for image processing and analysis (like measurement assistance and preset suggestions), this processing is applied to the ultrasound images themselves, not to in vitro samples.
No
The input letter 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
The LOGIQ E10s and LOGIQ Fortis are intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal, Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.
The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard). 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8inch High Resolution LED LCD monitor as an option).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal, Vascular).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician / hospital or medical clinic.
Description of the training set, sample size, data source, and annotation protocol
Auto Renal Measure Assistant:
The verification data was acquired independently during validation process after the development of the model.
Auto Abdominal Color Assistant:
The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two.
Auto Preset Assistant:
The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two.
Description of the test set, sample size, data source, and annotation protocol
Auto Renal Measure Assistant:
The number of individual patients' images were collected from: 30 Patients. The number of samples is 60 with 30 Longitudinal views and 30 Transverse view.
Gender: Male & Female Age: range 26-81 yrs old Ethnicity/Country; USA (58%) and Japan (42%)
The dataset used for final verification was collected prospectively on 30 demographically diverse patients at 2 sites: Japan and the USA exclusively with the system under consideration GE Logiq Fortis after the Auto Renal Measure Assistant function was developed using C1-6-D probe in Abdomen application.
The Validation set of 30 patient ( 60 images ) were loaded onto the LOGIQ validation system. 2 Readers (certified sonographer/Clinician) to ground truth the measurements: Length on the Longitudinal views and the Height and Width Measurements on the Transverse views. Board Certified Nephrologist arbitrated the ground truth between the above two readers to establish the reference standard for the dataset.
Auto Abdominal Color Assistant:
The number of individual patients' images were collected from: 50+ patients The number of samples, if different from above, and the relationshipbetween the two: 1100+ images.
Gender: Male & Female Age: Wide range, but specific age not collected Ethnicity/Country; USA (77%) and Australia (23%).
Mix of data from across three different probe models and two different Console variants. The data collection protocol was standardized across all data collection sites.
Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images. Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image. (Before running AI) Ran AI and created confusion matrix of ground truth vs AI predictions. Calculated the accuracies of the algorithm against each class.
Auto Preset Assistant:
The number of individual patients' images were collected from: 110+ patients The number of samples, if different from above, and the relationship between the two: 2600+ images.
Gender: Male & Female Age: Wide range, but specific age not collected Ethnicity/Country; USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%) and Greece (12%).
Mix of data from across five different probe models and three different Console variants. The data collection protocol was standardized across all data collection sites.
Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images. Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image. (Before running AI) Ran AI and created confusion matrix of ground truth vs AI predictions. Calculated the accuracies of the algorithm against each class.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Auto Renal Measure Assistant:
For Longitudinal model the accuracy of measurement is expected to be higher than 80% and for the Transverse model it is expected to be higher than 70%.
The Longitudinal model for length measurements has average accuracy of 96.45 with 95% CI of +/- 1.26% and average absolute error of 0.35cm at 95% CI of +/- 0.12 cm.
The Transverse model for width measurements has average accuracy of 92.94% with 95% CI of +/- 3.02% and average absolute error of 0.38cm at 95% CI of +/- 0.14 cm.
The Transverse model for width measurements has average accuracy of 93.13% with 95% CI of +/- 3.63% and average absolute error of 0.37cm at 95% CI of +/- 0.14 cm.
Auto Abdominal Color Assistant:
The overall model success rate of the Aorta, Kidney, Liver, GB, and Pancreas view suggestion is expected to be 80% or higher.
Auto Preset Assistant:
The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K211524 LOGIQ E10s, LOGIQ Fortis Diagnostic Ultrasound System
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.
K211488 LOGIQ E10 Diagnostic Ultrasound System, K202035 Vscan Air, K181685 Vivid E80/ Vivid E90/ Vivid E95 R3, K200743 Vivid E80/ Vivid E90/ Vivid E95 R4, K170445 LOGIQ S8, K202233 Venue Go
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
November 7, 2023
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 and Primary Care Diagnostic, LLC % Bryan Behn Regulatory Affairs Director 9900 Innovation Dr WAUWATOSA WI 53226
Re: K231989
Trade/Device Name: LOGIQ E10s, LOGIQ Fortis Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, IYN Dated: October 6, 2023 Received: October 6, 2023
Dear Bryan Behn:
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).
1
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 QS 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 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,
Yanna S. Kang -S
Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K231989 |
| Device Name | LOGIQ E10s, LOGIQ Fortis |
| Indications for Use (Describe) | The LOGIQ E10s and LOGIQ Fortis are intended for use by a qualified physician for ultrasound evaluation.
Specific clinical applications and exam types include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/
Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and
Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate);
Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal, Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler,
Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation
Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The LOGIQ E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic. |
| 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." | |
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
Main - 22
Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.
3
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K231989
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Nov 6, 2023 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Manufacturer: | GE Ultrasound Korea, Ltd. |
| 9, Sunhwan-ro 214 beon-gil, Jungwon-gu, | |
| Seongnam-si, Gyeonggi-do, 13204 Republic of Korea | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE HealthCare | |
| T:(262)247-5502 | |
| Alternate Contact Person: | Qingmeng Chen |
| Regulatory Affairs Program Manager | |
| GE HealthCare | |
| T: +86-18180590723 | |
| Device Trade Name: | LOGIQ E10s, LOGIQ Fortis |
| Common / Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| 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: | K211524 LOGIQ E10s, LOGIQ Fortis Diagnostic Ultrasound System |
| Reference Device(s): | K211488 LOGIQ E10 Diagnostic Ultrasound System |
| K202035 Vscan Air | |
| K181685 Vivid E80/ Vivid E90/ Vivid E95 R3 | |
| K200743 Vivid E80/ Vivid E90/ Vivid E95 R4 | |
| K170445 LOGIQ S8 | |
| K202233 Venue Go |
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Device description:
The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard). 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8inch High Resolution LED LCD monitor as an option).
Intended Use / Indications for Use:
The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal, Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The LOGIO E10s and LOGIO Fortis are intended to be used in a hospital or medical clinic.
Technology:
The LOGIQ E10s and LOGIQ Fortis employ the same fundamental scientific technology as its predicate device(s).
Determination of Substantial Equivalence:
The proposed LOGIQ E10s and LOGIQ Fortis are substantially equivalent to the predicate LOGIQ E10s and LOGIQ Fortis (K211524) with regards to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness.
The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
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The proposed LOGIQ E10s and LOGIQ Fortis and the predicate LOGIQ E10s and LOGIQ Fortis (K211524) have the similar clinical intended use however the following clinical application is being added to the proposed systems: Intraoperative (Abdominal).
The proposed LOGIQ E10s and LOGIQ Fortis and the predicate LOGIQ E10s and LOGIQ Fortis (K211524) have the same imaging modes.
The proposed LOGIQ E10s and LOGIQ Fortis are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The proposed LOGIO E10s and LOGIO Fortis have acoustic power levels which are below the applicable FDA limits.
The proposed LOGIQ E10s and LOGIQ Fortis and the predicate LOGIQ E10s and LOGIQ Fortis (K211524) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The proposed LOGIO E10s and LOGIO Fortis have been designed in compliance with approved electrical and physical safety standards.
The following is an overview of the differences between the proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQ E10s, LOGIQ Fortis (K211524).
Probes:
The probes supported in proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQ E10s, LOGIQ Fortis (K211524) are identical except:
- Addition of new probes:
Software:
The software features supported in proposed LOGIQ Fortis and the predicate LOGIQ E10s, LOGIQ Fortis (K211524) are identical except:
- Addition of new software features: ●
- Auto Preset Assistant -
- -Auto Abdominal Color Assistant
- -Auto Renal Measure Assistant
- -App Launchpad
- -Raw Data Streaming
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- Auto EF2.0 / AFI 2.0 -
- Vscan Air CL Support -
Hardware:
The hardware in proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQ E10s, LOGIQ Fortis (K211524) are identical except addition of Hardware: Subwoofer/Sound exciter.
Compatible device:
Addition of Vscan Air CL, wifi USB for Vscan Air CL and Wireless charger.
Appearance:
Minor updates on device front cover. Addition of U-light for LOGIQ E10s only.
AI Testing Summary
| Summary test statistics or other test results
including acceptance criteria or other
information supporting the appropriateness
of the characterized performance | For Longitudinal model the accuracy of measurement is expected to
be higher than 80% and for the Transverse model it is expected to be
higher than 70% The number of individual patients' images were collected from: 30
Patients. The number of samples is 60 with 30 Longitudinal views and 30
Transverse view |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information about clinical subgroups and
confounders present in the dataset | Gender: Male & Female Age: range 26-81 yrs old Ethnicity/Country; USA (58%) and Japan (42%) |
| Information about equipment and protocols
used to collect images | The datasetused for final verification was collected prospectively on 30
demographically
diverse patients at 2 sites: Japan and the USA exclusively with the system
under consideration
GE Logiq Fortis after the Auto Renal Measure Assistant function was
developed using C1-6-D
probe in Abdomen application; |
| Information about how the reference
standard was derived from the dataset (i.e.
the "truthing" process) | The Validation set of 30 patient ( 60 images ) were loaded onto the
LOGIQ validation system. 2 Readers (certified sonographer/Clinician) to ground truth the
measurements: Length on the Longitudinal views and the Height and
Width Measurements on the Transverse views. Board Certified Nephrologist arbitrated the ground truth between the
above two readers to establish the reference standard for the dataset Summary of Results: |
Auto Renal Measure Assistant : Al Summary of Testing ●
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| | The Longitudinal model for length measurements has average
accuracy of 96.45 with 95% CI of ± 1.26% and average absolute
error of 0.35cm at 95% CI of ±0.12 cm.
The Transverse model for width measurements has average accuracy
of 92.94% with 95% CI of ± 3.02% and average absolute error of
0.38cm at 95% CI of ±0.14 cm.
The Transverse model for width measurements has average accuracy
of 93.13% with 95% CI of ± 3.63% and average absolute error of
0.37cm at 95% CI of ±0.14 cm. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of how independence of test | The verification data was acquired independently during validation |
| data from training data was ensured | process after the development of the model as described above. |
. Auto Abdominal Color Assistant : Al Summary of Testing
●
| Summary test statistics or other test results
including acceptance criteria or other
information supporting the appropriateness
of the characterized performance | The overall model success rate of the Aorta, Kidney, Liver, GB, and
Pancreas view suggestion is expected to be 80% or higher. The number of individual patients' images were collected from: 50+
patients The number of samples, if different from above, and the relationship
between the two: 1100+ images |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information about clinical subgroups and
confounders present in the dataset | Gender: Male & Female Age: Wide range, but specific age not collected Ethnicity/Country; USA (77%) and Australia (23%) |
| Information about equipment and protocols
used to collect images | Mix of data from across three different probe models and two different
Console variants. The data collection protocol was standardized across all
data collection sites. |
8
Image /page/8/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the letters 'GE' in a stylized font, enclosed in a circular design. To the right of the logo is the text 'GE HealthCare' in a sans-serif font. The logo and text are both purple.
| Information about how the reference
standard was derived from the dataset (i.e.
the "truthing" process) | Before the process of data annotation, all information displayed on
the device is removed and performed on information extracted
purely from Ultrasound B-mode images. Readers (certified sonographer/Clinician) to ground truth the
"anatomy" visible in static B-Mode image. (Before running AI) Ran AI and created confusion matrix of ground truth vs AI
predictions. Calculated the accuracies of the algorithm against each class. |
|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of how independence of test
data from training data was ensured | The exams used for test/training validation purpose are separated from
the ones used during training process and there is no overlap between the
two. |
● Auto Preset Assistant : Al Summary of Testing
| Summary test statistics or other test results
including acceptance criteria or other
information supporting the appropriateness
| of the characterized performance | The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. The number of individual patients' images were collected from: 110+ patients The number of samples, if different from above, and the relationship between the two: 2600+ images |
|---|---|
| Information about clinical subgroups and | |
| confounders present in the dataset | Gender: Male & Female Age: Wide range, but specific age not collected Ethnicity/Country; USA (41.2%) , Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%) and Greece (12%). |
| Information about equipment and protocols | |
| used to collect images | Mix of data from across five different probe models and three 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) | Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images. Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image. (Before running AI) Ran AI and created confusion matrix of ground truth vs AI predictions. Calculated the accuracies of the algorithm against each class. |
| Description of how independence of test | |
| data from training data was ensured | The exams used for test/training validation purpose are separated from the |
| ones used during training process and there is no overlap between the two. |
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Image /page/9/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of the GE monogram in a purple circle on the left, followed by the words "GE HealthCare" in purple. The font is sans-serif and the letters are spaced closely together.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E10s, LOGIQ Fortis complies with voluntary standards:
- . ANSI AAMI ES60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012, C1:2009/(R)2012 & A2:2010/(R)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, Edition 4.1, 2020
- IEC 60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for ● the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing ● Within A Risk Management Process, Fifth edition, 2018
- ISO 14971, Medical devices Application of risk management to medical device, 2019 ●
- IEC 62359. Ultrasonics Field characterization Test methods for the determination of ● thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017
- 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.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ Fortis, did not require clinical studies to support substantial equivalence.
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Image /page/10/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design in purple. The text "GE HealthCare" is also in purple and is written in a clean, sans-serif font.
Conclusion:
GE HealthCare considers the LOGIQ E10s, LOGIQ Fortis to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).