(125 days)
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 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).
The provided text describes three AI features of the LOGIQ E10s and LOGIQ Fortis systems: Auto Renal Measure Assistant, Auto Abdominal Color Assistant, and Auto Preset Assistant. The information provided for each feature allows for a detailed breakdown of their acceptance criteria and the studies conducted to prove they meet these criteria.
Here's the requested information structured for clarity:
1. Table of Acceptance Criteria and Reported Device Performance
| AI Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Auto Renal Measure Assistant | Longitudinal model accuracy for length measurements expected to be > 80%. Transverse model accuracy for width measurements expected to be > 70%. | Longitudinal model for length measurements: Average accuracy of 96.45% (95% CI: ±1.26%), average absolute error of 0.35cm (95% CI: ±0.12 cm). Transverse model for width measurements (first mention): Average accuracy of 92.94% (95% CI: ±3.02%), average absolute error of 0.38cm (95% CI: ±0.14 cm). Transverse model for width measurements (second mention, likely a typo/repetition): Average accuracy of 93.13% (95% CI: ±3.63%), average absolute error of 0.37cm (95% CI: ±0.14 cm). |
| Auto Abdominal Color Assistant | Overall model success rate for Aorta, Kidney, Liver, GB, and Pancreas view suggestion expected to be 80% or higher. | Specific accuracy percentages for each view are not individually reported in the summary, but the success rate is implied to have met or exceeded the 80% threshold, as the device is deemed substantially equivalent. The summary states "Calculated the accuracies of the algorithm against each class," which suggests these were evaluated. |
| Auto Preset Assistant | Overall model success rate for Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid, and Carotid/Thyroid (Mixed) view suggestion expected to be 80% or higher. | Specific accuracy percentages for each view are not individually reported in the summary, but the success rate is implied to have met or exceeded the 80% threshold, as the device is deemed substantially equivalent. The summary states "Calculated the accuracies of the algorithm against each class," which suggests these were evaluated. |
2. Sample Sizes and Data Provenance for Test Sets
- Auto Renal Measure Assistant:
- Test Set Sample Size: 30 patients, resulting in 60 samples (30 longitudinal views, 30 transverse views).
- Data Provenance: Prospective collection. Data from USA (58%) and Japan (42%).
- Auto Abdominal Color Assistant:
- Test Set Sample Size: 50+ patients, resulting in 1100+ images.
- Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (77%) and Australia (23%).
- Auto Preset Assistant:
- Test Set Sample Size: 110+ patients, resulting in 2600+ images.
- Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).
3. Number of Experts and Qualifications for Ground Truth
- Auto Renal Measure Assistant:
- Number of Experts: 2 "Readers" and 1 "Board Certified Nephrologist" for arbitration.
- Qualifications: "certified sonographer/Clinician" for the two readers. "Board Certified Nephrologist" for the arbitrator.
- Auto Abdominal Color Assistant:
- Number of Experts: Unspecified number of "Readers".
- Qualifications: "certified sonographer/Clinician" for the readers.
- Auto Preset Assistant:
- Number of Experts: Unspecified number of "Readers".
- Qualifications: "certified sonographer/Clinician" for the readers.
4. Adjudication Method for Test Sets
- Auto Renal Measure Assistant:
- Method: A "Board Certified Nephrologist arbitrated the ground truth between the above two readers to establish the reference standard". This implies a 2+1 (two readers, one arbitrator) method.
- Auto Abdominal Color Assistant & Auto Preset Assistant:
- Method: The text states, "Readers (certified sonographer/Clinician) to ground truth the 'anatomy' visible in static B-Mode image." There is no mention of multiple readers or an arbitration process, implying no explicit inter-reader adjudication method was described beyond individual expert annotation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly described in the provided text. The studies focus on the standalone performance of the AI algorithms against a derived ground truth, rather than comparing human reader performance with and without AI assistance. Therefore, no effect size for human readers' improvement with AI assistance is reported.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone (algorithm only) performance studies were done for all three AI features listed. The studies evaluate the accuracy or success rate of the AI algorithms in performing their intended functions (measurement, view suggestion) against an established ground truth, without a human-in-the-loop component being explicitly tested or reported.
7. Type of Ground Truth Used
- Auto Renal Measure Assistant: Expert Consensus, as it involved two readers and an arbitrator to establish the reference standard for measurements.
- Auto Abdominal Color Assistant & Auto Preset Assistant: Expert Annotation/Consensus, established by "Readers (certified sonographer/Clinician) to ground truth the 'anatomy'visible in static B-Mode image." While not explicitly stated as consensus among multiple readers, it is established by qualified experts.
8. Sample Size for Training Sets
- The training set sample sizes are not explicitly provided in the summaries for any of the AI features. The document only mentions that the "verification data was acquired independently during validation process after the development of the model," and "The exams used for test/training validation purpose are separated from the ones used during training process." This implies training data existed but its size is not detailed.
9. How Ground Truth for Training Sets Was Established
- The document does not explicitly describe how the ground truth for the training sets was established. It focuses primarily on the process for the test/validation sets. However, it can be inferred that a similar process involving expert clinicians/sonographers would have been used to establish ground truth for training data, as is common practice in medical imaging AI development.
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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).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration 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 andPediatric); 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, AttenuationImaging 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information Officer | |
| Paperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation 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.
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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, LLC9900 Innovation DrWauwatosa, 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 BehnRegulatory Affairs DirectorGE HealthCareT:(262)247-5502 |
| Alternate Contact Person: | Qingmeng ChenRegulatory Affairs Program ManagerGE HealthCareT: +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 SystemK202035 Vscan AirK181685 Vivid E80/ Vivid E90/ Vivid E95 R3K200743 Vivid E80/ Vivid E90/ Vivid E95 R4K170445 LOGIQ S8K202233 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 resultsincluding acceptance criteria or otherinformation supporting the appropriatenessof the characterized performance | For Longitudinal model the accuracy of measurement is expected tobe higher than 80% and for the Transverse model it is expected to behigher than 70% The number of individual patients' images were collected from: 30Patients. The number of samples is 60 with 30 Longitudinal views and 30Transverse view |
|---|---|
| Information about clinical subgroups andconfounders present in the dataset | Gender: Male & Female Age: range 26-81 yrs old Ethnicity/Country; USA (58%) and Japan (42%) |
| Information about equipment and protocolsused to collect images | The datasetused for final verification was collected prospectively on 30demographicallydiverse patients at 2 sites: Japan and the USA exclusively with the systemunder considerationGE Logiq Fortis after the Auto Renal Measure Assistant function wasdeveloped using C1-6-Dprobe in Abdomen application; |
| Information about how the referencestandard was derived from the dataset (i.e.the "truthing" process) | The Validation set of 30 patient ( 60 images ) were loaded onto theLOGIQ validation system. 2 Readers (certified sonographer/Clinician) to ground truth themeasurements: Length on the Longitudinal views and the Height andWidth Measurements on the Transverse views. Board Certified Nephrologist arbitrated the ground truth between theabove 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 averageaccuracy of 96.45 with 95% CI of ± 1.26% and average absoluteerror of 0.35cm at 95% CI of ±0.12 cm.The Transverse model for width measurements has average accuracyof 92.94% with 95% CI of ± 3.02% and average absolute error of0.38cm at 95% CI of ±0.14 cm.The Transverse model for width measurements has average accuracyof 93.13% with 95% CI of ± 3.63% and average absolute error of0.37cm 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 resultsincluding acceptance criteria or otherinformation supporting the appropriatenessof the characterized performance | The overall model success rate of the Aorta, Kidney, Liver, GB, andPancreas 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 relationshipbetween the two: 1100+ images |
|---|---|
| Information about clinical subgroups andconfounders 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 protocolsused to collect images | Mix of data from across three different probe models and two differentConsole variants. The data collection protocol was standardized across alldata collection sites. |
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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 referencestandard was derived from the dataset (i.e.the "truthing" process) | Before the process of data annotation, all information displayed onthe device is removed and performed on information extractedpurely 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 AIpredictions. Calculated the accuracies of the algorithm against each class. |
|---|---|
| Description of how independence of testdata from training data was ensured | The exams used for test/training validation purpose are separated fromthe ones used during training process and there is no overlap between thetwo. |
● Auto Preset Assistant : Al Summary of Testing
| Summary test statistics or other test resultsincluding acceptance criteria or otherinformation supporting the appropriatenessof 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 andconfounders 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 protocolsused to collect images | Mix of data from across five different probe models and three differentConsole variants. The data collection protocol was standardized across alldata collection sites. |
| Information about how the referencestandard 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 testdata from training data was ensured | The exams used for test/training validation purpose are separated from theones used during training process and there is no overlap between the two. |
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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).
§ 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.