(119 days)
Yes
The document explicitly mentions and provides details on the training and testing of features like SonoPelvicFloor2.0, Fibroid Mapping, and SonoLyst/SonoLyst Live, which are described with metrics like accuracy, success rates, and DICE scores, consistent with the evaluation of AI/ML algorithms. The "Mentions AI, DNN, or ML" field is also marked as "Yes".
No
The description states the device is "a general purpose ultrasound system intended for use by qualified and trained healthcare professionals." Its modes of operation and intended applications (Fetal/OB, Abdominal, Cardiac, Musculo-skeletal, etc.) are for imaging and diagnosis, not for treating or curing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "Specific clinical applications," which include various anatomical sites and conditions (e.g., Fetal/OB, Abdominal, Cardiac, Musculo-skeletal). These explicitly diagnostic applications, combined with the comprehensive imaging modes and the intention for use by "qualified and trained healthcare professionals" in a "hospital or medical clinic," indicate its role in clinical diagnosis.
No
The device description explicitly states the systems consist of a mobile console with keyboard control panel, color LCD/TFT touch panel, color video display, optional image storage and printing devices, and utilize various transducers. These are hardware components, indicating it is not a software-only 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 that the device is a "general purpose ultrasound system intended for use by qualified and trained healthcare professionals." It lists various clinical applications related to imaging and analysis of the human body. IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mobile console with imaging and analysis capabilities, utilizing transducers to acquire ultrasound images in vivo (within the body). This aligns with the function of an ultrasound system, not an IVD.
- Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly.
- Input Imaging Modality: The input is Ultrasound, which is an in vivo imaging technique.
- AI/ML Features: While the device incorporates AI/ML for image processing and analysis (SonoPelvicFloor2.0, Fibroid Mapping, SonoLyst/SonoLyst Live), these features are applied to the ultrasound images acquired from the patient, not to in vitro specimens. The AI is assisting in the interpretation and analysis of the in vivo imaging data.
In summary, the device is a diagnostic imaging system that uses ultrasound to visualize structures within the body. While it aids in diagnosis, it does so through in vivo imaging and analysis, not through the examination of specimens in vitro.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The VolusonTM Expert 18, VolusonTM Expert 20, VolusonTM Expert 22 is intended to be used in a hospital or medical clinic.
Product codes
IYN, IYO, ITX
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The following probes are the same as the predicate: RIC5-9-D, IC5-9-D, RIC6-12-D, 9L-D, 11L-D, ML6-15-D, RAB6-D, C1-6-D, C2-9-D, M5Sc-D, RM7C, eM6CG3, RSP6-16-D , RIC10-D, 6S-D and L18-18i-D. The RIC12-D is a new probe and is substantially equivalent to the RIC6-12-D, it is an incremental improvement in technology.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained healthcare professionals. The VolusonTM Expert 18, VolusonTM Expert 20, VolusonTM Expert 22 is intended to be used in a hospital or medical clinic.
Description of the training set, sample size, data source, and annotation protocol
SonoPelvicFloor2.0: Our train data consists of 983 distinct volumes from 616 individual patients volume were acquired in multiple phases of examination – Rest, Contraction and/or rest. Using these 983 volumes we generated 8847 images - 3 slices from each volume with three rotation angles per image. Data is provided by external clinical partners who de-identified the data before sharing it with us. Original data is collected in the form of 4D volume Cines in *.vol or *.4dv data formats. The data is acquired from women examined in regular clinical practice across multiple geographical sites. We do not acquire explicit information regarding age or ethnicity of each patient because of privacy constraints around PHI. Any identifying information such as age and ethnicity are removed during data anonymization step.
Fibroid Mapping: A total of 779 unique volumes are utilized to train the model. With augmentations, 7790 volumes are generated. Data is provided by external clinical partners who de-identified the data before sharing it with us. Original data is collected in the form of 4D volume Cines in *.vol or *.4dv data formats. We collected training data of the following types from hospital centers as well as private practices. We provided a dedicated data collection protocol explaining the required data needs to each provider. The data is acquired from women examined in regular clinical practice across multiple geographical sites. We do not acquire explicit information regarding age or ethnicity of each patient because of privacy constraints around PHI. Any identifying information such as age and ethnicity are removed during data anonymization step.
Sonolyst/Sonolyst Live: Data used for both training and validation has been collected across multiple geographical sites using different systems to represent the variations in target population. Still images were obtained in DICOM & JPEG format, cine loops in RAW data format. Data was collected from routine clinical practice in hospitals and private practice during mid-trimester examinations, with a gestational age range of 18-24 weeks.
Description of the test set, sample size, data source, and annotation protocol
SonoPelvicFloor2.0: Total Volumes: 94 for verification. Data is provided by external clinical partners who de-identified the data before sharing it with us. Original data is collected in the form of 4D volume Cines in *.vol or *.4dv data formats.
Fibroid Mapping: Primary verification on 78 Total Volumes. Secondary evaluation on 74 Total Volumes. For quantitative analysis, 74 volumes. Data is provided by external clinical partners who de-identified the data before sharing it with us. Original data is collected in the form of 4D volume Cines in *.vol or *.4dv data formats. We maintain a database containing relevant information for all datasets used during training and verification of this feature in an SQL database. The datasets contained in the collections for training and verification are mutually exclusive and stem from a mutually exclusive list of patients.
SonolyST/Sonolyst Live: For SonoLyst 2nd Trimester IR in total 42102 images are used for quantitative evaluation. For SonoLyst 2nd Trimester X in total 10424 images are used for quantitative evaluation. For SonoLystLive 2nd Trimester in total 5666 images are used for quantitative evaluation. The images were curated (sorted and graded) by a single sonographer. The images were sorted and graded by ScanNav AutoCapture Second Trimester. This process resulted in some images being reclassified during sorting. Where they differed from the ground truth, the sorted images from step 2 were reviewed by a 5-sonographer review panel, in order to determine the sorting accuracy of the system. The sorting process resulted in some images being reclassified based upon the majority view of the panel. Where they differed from the ground truth, the graded images from step 1 were reviewed by a 5-sonographer review panel, in order to determine the grading accuracy of the system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SonoPelvicFloor2.0: The verification for the SonoPelvicFloor2.0 AI feature is performed by clinical experts following a specific Workflow. Accuracy of 96% on good IQ datasets and 93% on challenging IQ cases.
Fibroid Mapping: The verification was performed by clinical experts. Success rate of each AI component (uterus, endometrium, and fibroid segmentation) should be 70% or higher. Primary verification qualitative results: Uterus 95%, Endometrium 89%, Fibroids 88%. Secondary evaluation qualitative results: Uterus 100%, Endometrium 91%, Fibroids 88%. Quantitative evaluation using DICE scores when successful: Uterus 0.89 ± 0.03, Endometrium 0.70 ± 0.18, Fibroids 0.70 ± 0.13.
Sonolyst/Sonolyst Live: The verification of the SonoLystLive 2nd Trimester features is based on the average agreement between a sonographer panel and the output of the algorithm regarding Traffic light quality. The average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is 80% or higher.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SonoPelvicFloor2.0: Accuracy: 96% on good IQ datasets and 93% on challenging IQ cases.
Fibroid Mapping: Success Rate: Uterus 95% (primary), 100% (secondary); Endometrium 89% (primary), 91% (secondary); Fibroids 88% (primary), 88% (secondary). DICE scores: Uterus 0.89 ± 0.03 (successful); Endometrium 0.70 ± 0.18 (successful), 0.29 ± 0.27 (failed); Fibroids 0.70 ± 0.13 (successful), 0.48 ± 0.17 (failed).
Sonolyst/Sonolyst Live: Average success rate: 80% or higher for SonoLyst 2nd Trimester IR and X and overall traffic light accuracy.
Predicate Device(s)
K220358 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 Diagnostic Ultrasound System
Reference Device(s)
K230346 Voluson SWIFT, Voluson SWIFT+
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.
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GE Medical Systems Ultrasound and Primary Care Diagnostics % Bryan Behn Regulatory Affairs Director GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. 9900 Innovations Dr. WAUWATOSA WI 53226
Re: K231965
Trade/Device Name: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 29, 2023 Received: October 2, 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).
October 30, 2023
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Your device is also subject to, among other requirements, the Quality System (OS) 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, Ph.D. 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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Indications for Use
510(k) Number (if known) K231965
Device Name
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Indications for Use (Describe)
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary K231965
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: Oct 23, 2023 Submitter: GE Healthcare [GE Healthcare Austria GmbH & Co OG] Tiefenbach 15 Zipf, Austria 4871 Primary Contact Bryan Behn Regulatory Affairs Director Person:
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Dr. Wauwatosa, WI 53226 T:(262)247-5502 F:(414)918-8275
-
Thomas Reisenberger Secondary Contact Sr. Regulatory Affairs Leader Person: GE Healthcare Austria GmbH & Co OG T:(+43)7682-3800-332 F:(+43)7682 3800-47
Device: Trade Voluson Expert Series Name: Models: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 Common/Usual Ultrasound system Name: Class II Classification Names: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO -
Primary Predicate K220358 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 Diagnostic Ultrasound System Device(s):
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
| Classification Names: | Class II |
|---|---|
| Product Code: | 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 | |
| Classification Names: | |
| Product Code: | 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 systems are full-featured Track 3 ultrasound systems, primarily for |
| general radiology use and specialized for OB/GYN with particular | |
| features for real-time 3D/4D acquisition. They consist of a mobile | |
| console with keyboard control panel; color LCD/TFT touch panel, | |
| color video display and optional image storage and printing devices. | |
| They provide high performance ultrasound imaging and analysis and | |
| have comprehensive networking and DICOM capability. They utilize a | |
| variety of linear, curved linear, matrix phased array transducers | |
| including mechanical and electronic scanning transducers, which | |
| provide highly accurate real-time three-dimensional imaging | |
| supporting all standard acquisition modes. | |
| The following probes are the same as the predicate: RIC5-9-D, IC5-9- | |
| D, RIC6-12-D, 9L-D, 11L-D, ML6-15-D, RAB6-D, C1-6-D, C2-9-D, | |
| M5Sc-D, RM7C, eM6CG3, RSP6-16-D , RIC10-D, 6S-D and L18-18i- | |
| D. The RIC12-D is a new probe and is substantially equivalent to the | |
| RIC6-12-D, it is an incremental improvement in technology. | |
| Intended Use: | The device is a general purpose ultrasound system intended for use by |
| qualified and trained healthcare professionals. Specific clinical | |
| applications remain the same as previously cleared: | |
| Fetal/OB; Abdominal (including GYN, pelvic and infertility | |
| monitoring/follicle development); Pediatric; Small Organ (breast, | |
| testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and | |
| pediatric); Musculo-skeletal Conventional and Superficial; Vascular; | |
| Transvaginal (including GYN); Transrectal | |
| 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 | |
| and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, | |
| B/Power/ PWD, B/Elastography. The VolusonTM Expert 18, VolusonTM | |
| Expert 20, VolusonTM Expert 22 is intended to be used in a hospital or |
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K230346 Voluson SWIFT, Voluson SWIFT+ Reference Predicatee Device(s):
medical clinic.
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- The Voluson Expert Series (Voluson E22/20/18) employs the same Technology: fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicates
Substantial The proposed Voluson Expert 22/20/18 is substantially equivalent to Equivalence: the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
Model Names and Model differences:
Voluson Expert 18, Voluson Expert 20 and Voluson Expert 22 are same in hardware . Voluson Expert 18 is lower version and not all probes or functions are available. Voluson Expert 20 is mid version and product with complete configuration with all the probes and functions of software with exception of 4D electronically probe RIC6-12-D, eM6CG3 and RIC12-D. The high-end model Voluson Expert 22 supports all probes including electronical 4D probe eM6C G3.
- The systems are all intended for diagnostic ultrasound imaging . and fluid flow analysis.
- The proposed Voluson Expert 22/20/18 and predicate Voluson . Expert 22/20/18 systems have the same clinical intended use.
- . The proposed Voluson Expert 22/20/18 and predicate Voluson Expert 22/20/18 systems have the same imaging modes.
- . The proposed Voluson Expert 22/20/18 and predicate Voluson Expert 22/20/18 system transducers are equivalent. One new transducer RIC12-D was added.
- . There is no change to the system indications for use.
- The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The proposed Voluson Expert Series 22/20/18 and predicate Expert 22/20/18 system have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The proposed Voluson Expert Series 22/20/18 and predicate systems have been designed in compliance with approved
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electrical and physical safety standards.
- There proposed Voluson Expert Series 22/20/18 and predicate . Expert 22/20/18 system Software Features are equivalent. Some minor improvements to the existing Software features have been implemented into the proposed system.
- The proposed Voluson Expert Series 22/20/18 adds additional . AI software features SonoPelvicFloor2.0 (extension of existing Feature SonoPelvicFloor) , SonoAVC2.0 (extension of existing Feature SonoAVC), Fibroid Mapping (as part of Option SonoGYN) to the system. Additional the existing features SonoLyst/ Sonolyst Live have been improved.
- The proposed Voluson Expert Series 22/20/18 adds additional ● software features BSI (Blood Speckle Imaging) and Ophthalmic Artery Measurement to the system.
7
AI Verification Summary:
SonoAVC2.0 (also described as Auto-Caliper):
The proposed Voluson Expert Series 22/20/18 BT24 feature SonoAVC2.0 migrated from already cleared (K230346) Voluson SWIFT, Voluson SWIFT+ software feature called Auto Caliper.
SonoPelvicFloor2.0
Summary test statistics or acceptance criteria
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.
· Data used for both training and validation has been collected across multiple geographical sites using different systems and probe configuration to represent the variations in target population. The distribution of test data is as follows:
Total Volumes: 94
- Distribution by Systems: Voluson Expert 22 (82), Voluson E8 (8), Voluson E6 (4) -
- Distribution by Probes: RAB6-D (41), RIC5-9-D (21), RM7C (32) -
- -Distribution by Countries: Austria (36), U.S.A (47), South Africa (4), Czech Republic (7)
· The verification for the SonoPelvicFloor2.0 AI feature is performed by clinical experts following a specific Workflow:
-
- Import the entire data pool into the Archive on the system.
-
- Load the datasets one-by-one from the Archive
-
- Assess and document the volume cine quality.
-
- Check if the MHD plane can be found in the volume cine with clinically required quality. If the plane cannot be found/tracked, then mark the corresponding result as 'N/A'.
-
- Press the Init button on the UI.
-
- Enter the SonoPelvicFloor tool.
-
- Draw the OmniView line to capture the MHD plane at the first frame. Start the Live tracking algorithm as follows 4D - SonoPelvicFloor - Live Tracking
-
- Observe the automated placement of the MHD plane during live tracking on all frames of the cine loop.
-
- If the result was not deemed 'N/A' in step 4), then document the assessment (by internal clinical expert) as Success/No result/Failure.
-
- The final dataset obtained after these steps should be stored back to the archive.
Expected result: On datasets that were marked as Good in Image/Cine Quality (IQ) assessment, the success rate should be 70% or higher. On datasets that were marked as challenging in image/cine quality measure the success rate of the feature should be 60% or higher.
Our algorithm is shown to yield an accuracy of 96% on good IQ datasets and 93% on challenging IQ cases.
Data collection
Data is provided by external clinical partners who de-identified the data before sharing it with us. Original data is collected in the form of 4D volume Cines in *. vol or *. 4dv data formats. This preserves the flexibility to re-process data to our needs retrospectively during scan conversion.
8
Our train data consists of 983 distinct volumes from 616 individual patients volume were acquired in multiple phases of examination – Rest, Contraction and/or rest. Using these 983 volumes we generated 8847 images - 3 slices from each volume with three rotation angles per image. The distribution of 983 volumes is as follows:
- -Distribution by Systems: V730 (116), Voluson E10 (482), Voluson E6 (21), Voluson E8 (90), Voluson P8 (274)
- -Distribution by Probes: RAB 4-8L (116), RAB2-6-RS (38), RAB6-D (111), RIC5-9A-RS (236), RIC5-9-D (8), RM6C (474)
- Distribution by Countries: Australia (116), Austria (8), Belgium (465), Czech Republic (100), Japan -(236), Italy (37), South Africa (21)
Demographic distribution
The data is acquired from women examined in regular clinical practice across multiple geographical sites. We do not acquire explicit information regarding age or ethnicity of each patient because of privacy constraints around PHI. Any identifying information such as age and ethnicity are removed during data anonymization step. However, acquiring data from regular practice across multiple sites/countries/clinical practices encourages implicit diversity in age and ethnicity and patient characteristics distribution in the collected datasets.
Clinical Subgroups and Confounders
The clinical subgroups/confounders present in the evaluation pool is as follows:
-
- Image Quality: Good image quality and Challenging image quality The accuracy of algorithm on the above subgroups is: Good IQ: 96.2% Challenging IQ: 93.3%
-
- Evaluation Phase: Rest, Contraction or Valsalva The accuracy of algorithm on the above subgroups is: Rest : 100% Contraction: 93.75% Valsalva: 96.55%
Equipment and protocols
The testing data was collected from hospital centers as well as private practices following the standard clinical protocol across multiple GE systems and probe configurations. Summary of the evaluation pool distribution is as follows:
Total Volumes: 94
- Distribution by Systems: Voluson Expert 22 (82), Voluson E8 (8), Voluson E6 (4) -
- Distribution by Probes: RAB6-D (41), RIC5-9-D (21), RM7C (32) -
- -Distribution by Countries: Austria (36), U.S.A (47), South Africa (4), Czech Republic (7)
Independence of Test-Train data
We maintain a database containing relevant information for all datasets used during training and verification of this feature in an SQL database. The datasets contained in the collections for training and verification are mutually exclusive and stem from a mutually exclusive list of patients.
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In addition, we also perform testing on data acquired from site (namely U.S.A.) which did not contribute to the training data pool. The satisfactory performance on the new/unseen data distribution from these sites indicate towards the good generalizability of our models/algorithm.
Fibroid Mapping:
Summary test statistics or acceptance criteria
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.
· Data used for training, validation, and verification (evaluation) has been collected across multiple geographical sites using different probe configurations to represent the variations in target population.
· The verification was performed by clinical experts according to the following protocol:
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- Invoke Fibroid Pre Mapping Menu. 2D: Do a scan, find the mid sagittal plane and enter 3D pre and select "Fibroid Mapping" OR 3D Find mid sagittal plane in Volume, enter Volume analysis and select "Fibroid Mapping".
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- Trace uterus midline on touchscreen
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- Freeze and acquire.
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- Invoke Fibroid Mapping Main
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- Start the auto segmentation after 3D acquired.
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- Check if the segmentation is satisfying. If not return to step 2). Otherwise, select "Add to Report" to save measurements to the current exam.
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- Semi-Automated Fibroid Segmentation: Position the curser over a fibroid to be measured on the section plane and click the Add/Rem button to add or remove fibroids. Repeat for all fibroids on current plane.
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- If all fibroids in the plane are segmented correctly, adjust the sectional plane with parallel shift and repeat step 7).
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- Select "Add to Report" to save the measurements to the current exam.
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- If segmentation quality of a fibroid is not satisfactory, activate manual fibroid segmentation (Add Fibroid Manually)
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- Select measurement tool "Ellipse" or "Double Calipe". Enter the start and end point of the long and short diameter using the trackball. Measure all wanted fibroids on current plane.
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- Adjust the plane with parallel shift to achieve next slice position and continue with step 7) or 10)
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- To save measurement to the current exam select "Add to Report".
- The success rate of each AI component of the feature (uterus, endometrium, and fibroid segmentation) should be 70% or higher.
- . Rationale for clinical adequacy:
Requirements for success rates of this workflow tool were discussed with internal and external clinical experts. User scanning experience and expected image quality in clinical practice was considered and reflected in the verification data pool. Based on the expert opinion the above success rates are considered appropriate.
The original verification of the feature was performed on a data pool consisting of:
Total Volumes: 78
- Systems: Voluson Expert Series
- Probes: RIC5-9-D, RIC6-12-D
- Countries: Egypt, Greece, Korea, Philippines, Romania, USA.
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Primary verification - qualitative results:
| Uterus | 95% |
|---|---|
| Endometrium | 89% |
| Fibroids | 88% |
We then performed a secondary evaluation including a quantitative assessment as well as a stratified performance analysis per confounders as follows:
Total Volumes: 74
- Systems: Voluson Expert Series -
- Probes: RIC5-9-D, RIC10-D -
- Countries: Austria, Egypt, Germany, Greece, Korea, Philippines, Romania, USA -
Secondary evaluation - qualitative results:
| Uterus | 100% |
|---|---|
| Endometrium | 91% |
| Fibroids | 88% |
The clinical requirements are thus successfully met in both verification rounds.
Further details of the quantitative assessment results can be found in the dedicated subsection below. All our experiments confirm the high accuracy as well as strong generalization capabilities of the Fibroid Mapping automation feature.
Data collection
Data is provided by external clinical partners who de-identified the data before sharing it with us. Original data is collected in the form of 4D volume Cines in *. vol or *. 4dv data formats. This preserves the flexibility to re-process data to our needs retrospectively during scan conversion.
A total of 779 unique volumes are utilized to train the model. With augmentations, 7790 volumes are generated.
A total of 31 unique volumes are utilized to validate the model. With augmentations, 310 volumes are generated.
We collected training data of the following types from hospital centers as well as private practices. We provided a dedicated data collection protocol explaining the required data needs to each provider.
- Systems: Voluson E10, E8, E6, S10, S8, S6, P8. -
- Probes: RIC5-9-D, RIC6-12-D, RM6C, RIC5-9A-RS, RIC5-9W-RS. -
- -Countries: Austria, Egypt, France, Greece, Korea, Poland, Romania, USA.
For an overview of the data used for verification (evaluation), please see the preceding subsection of this summary.
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Demographic distribution
The data is acquired from women examined in regular clinical practice across multiple geographical sites. We do not acquire explicit information regarding age or ethnicity of each patient because of privacy constraints around PHI. Any identifying information such as age and ethnicity are removed during data anonymization step. However, acquiring data from regular practice across multiple sites/countries/clinical practices encourages implicit diversity in age and ethnicity and patient characteristics distribution in the collected datasets.
Information about clinical subgroups and confounders
We considered the following relevant confounders to analyze the performance of our algorithms on subgroups: uterus position, endometrial phase, fibroid location, probes, and geographic regions. Our analysis shows that our algorithms perform consistently well across all the subgroups.
Quantitative evaluation
The data pool for quantitative analysis consists of 74 volumes. Data is provided by external clinical partners who de-identify the data before sharing it with GE HealthCare. Original data is collected in the form of 3D volumes in *. vol data format. This preserves the flexibility to re-process data to our needs retrospectively during scan conversion. The results show high accuracy of the algorithms and a correlation between DICE scores (i.e., Dice coefficient) and qualitative assessment by independent clinical experts.
| Anatomy | DICE when successful | DICE when failed |
|---|---|---|
| Uterus | 0.89 ± 0.03 | n/a |
| Endometrium | 0.70 ± 0.18 | 0.29 ± 0.27 |
| Fibroids | 0.70 ± 0.13 | 0.48 ± 0.17 |
Equipment and protocols
- · Data is provided by external clinical partners who de-identified the data.
- · Original data is collected in the form of 3D/4D volumes to preserve the flexibility to re-process data retrospectively during scan conversion.
- · A data collection protocol is provided to each site to explain the required data needs.
Independence of Test-Train data
We maintain a database containing relevant information for all datasets used during training and verification of this feature in an SQL database. The datasets contained in the collections for training and verification are mutually exclusive and stem from a mutually exclusive list of patients.
In addition, we also perform testing on data acquired from sites (namely, in Germany and Austria) which did not contribute to the training data pool. The satisfactory performance on the new/unseen data distribution from these sites indicate towards the good generalizability of our models/algorithm.
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Sonolsyt/Sonolyst Live (existing Features was improved and extended)
The basic functionality of SonoLyst Live feature were already submitted as AI feature and cleared with the submission K220358.
With this submission (K231965) the following changes occurred compared to (K220358):
- -Added views
- o Lower Limb, with following criteria: Magnification, Upper leg visible, Lower leg visible, foot visible.
- Upper Limb, with following criteria: Magnification, Upper arm visible, Forearm visible o
- User Interface changes -
- The sagittal spine view contained the grading criteria "Sacrum visible", "Lumbar visible", o "Thoracic visible", and "Cervical visible". In order to simply the workflow for the user, these criteria are directly accessible to the user at view level as "Spine Sacrum", "Spine Lumber" "Spine Thoracic", and "Spine Cervical", without changing the underlaying AI algorithm.
- The Lower Limb view contains the grading criteria "Upper Leg visible", "Lower leg visible", o "Foot visible". In order to simply the workflow for the user, these criteria are directly accessible to the user at view level as "Upper Leg", "Lower Leg" and "Sagittal foot", without changing the algorithm.
- o The Upper Limb view contains the grading criteria "Upper Arm visible" and "Forearm visible". In order to simply the workflow for the user, these criteria are directly accessible to the user at view level as "Upper Arm", and "Forearm", without changing the algorithm.
- Manual Indication of left/right hands/feet/extremities added. o
- Status hexagon shown also while in Scan Assistant. O
- Automatically stores images in real-time during exam. o
Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.
- Data used for both training and validation has been collected across multiple geographical sites using different systems to represent the variations in target population.
- The verification for the SonoLyst 2nd Trim IR&X feature is based on computing confusion matrices ● for the sorting (SonoLyst IR) and grading (SonoLyst X) features.
- The verification of the SonoLystLive 2nd Trimester features is based on the average agreement between a sonographer panel and the output of the algorithm regarding Traffic light quality.
- The average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is ● 80% or higher.
Data Collection and Distribution:
- Systems: GE Voluson V730, E6, E8, E10, Siemens Acuson S2000 and Hitachi Aloka
- Formats: Still images were obtained in DICOM & JPEG format, cine loops in RAW data format. ●
- Countries: UK, Austria, India and USA ●
- Total number of images: 2.2M ●
- Total number of cine loops: 2570 ●
Quantitative evaluation:
For SonoLyst 2nd Trimester IR in total 42102 images are used for quantitative evaluation
For SonoLyst 2nd Trimester X in total 10424 images are used for quantitative evaluation
For SonoLystLive 2nd Trimester in total 5666 images are used for quantitative evaluation
Information about clinical subgroups and confounders
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In order to demonstrate the generalization performance of the quantitative evaluation is performed for two subgroups: a data set containing of a variety of ultrasound systems and data formats against a data set containing the target platform. For both subgroups the acceptance criteria are met.
Equipment and protocols
Equipment: GE Voluson V730, E6, E8, E10, Siemens Acuson S2000 and Hitachi Aloka
Data was collected from routine clinical practice in hospitals and private practice during mid-trimester examinations, with a gestational age range of 18-24 weeks.
Information about the reference standard and dataset ("truthing process"):
To ensure the quality of the curated data for verification, the following strategy is employed:
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- The images were curated (sorted and graded) by a single sonographer.
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- The images were sorted and graded by ScanNav AutoCapture Second Trimester. This process resulted in some images being reclassified during sorting.
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- Where they differed from the ground truth, the sorted images from step 2 were reviewed by a 5sonographer review panel, in order to determine the sorting accuracy of the system.
The sorting process resulted in some images being reclassified based upon the majority view of the panel.
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- Where they differed from the ground truth. the graded images from step 1 were reviewed by a 5sonographer review panel, in order to determine the grading accuracy of the system.
Conclusion: GE Healthcare considers the Voluson Expert 20 and Expert 22 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
- Where they differed from the ground truth. the graded images from step 1 were reviewed by a 5sonographer review panel, in order to determine the grading accuracy of the system.
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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Voluson Expert Series 22/20/18 and its applications comply with voluntary standards:
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED . VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, Edition 4.1 CONSOLIDATED VERSION 2020
- . IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO10993-1, Biological evaluation of medical devices Part 1: ● Evaluation and testing within a risk management process, 2018
- ISO14971, Application of risk management to medical devices: Third Edition 2019
- . NEMA PS 3.1 - 3.20 (2022a), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
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)
- Final Acceptance Testing (Validation)
Transducer materials and other patient contact materials are biocompatible.
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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The logo is enclosed within a circular border, and the entire design is rendered in a light blue color.
Summary of Clinical Tests:
The subject of this premarket submission, Voluson Expert Series 22/20/18 did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Voluson Expert Series 22/20/18 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).