(132 days)
K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System
Yes
The document explicitly mentions "AI Verification Summary" and describes the training and testing of an "Auto-Caliper AI feature".
No
The device is described as a "general-purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement, display and analysis of the human body and fluid." Its primary function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system..." and refers to "ultrasound imaging, measurement, display and analysis of the human body and fluid."
No
The device description explicitly states it consists of a "mobile console with control panel, full touch monitor, optional image storage and printing devices" and utilizes "a variety of linear, curved linear, matrix phased array transducer including mechanical and electronic scanning transducers," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Voluson SWIFT, Voluson SWIFT+ is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes an imaging modality, not a laboratory test on a sample.
- Mode of Operation: The listed modes (B, M, Doppler, etc.) are all standard ultrasound imaging and measurement techniques.
- Device Description: The description focuses on the hardware (console, transducers) and its imaging capabilities.
- AI Feature: While the device incorporates AI for features like Auto-Caliper, this AI is used to assist in the interpretation and measurement of the ultrasound images, not to perform a test on a biological sample.
Therefore, the Voluson SWIFT, Voluson SWIFT+ is a diagnostic imaging device, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text only mentions "Control Plan Authorized (PCCP)" but immediately follows it with "Not Found", indicating no relevant text about its authorization.
Intended Use / Indications for Use
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including UrologyProstate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM (Anatonical M-Mode), PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow (High Definition-Flow), Harmonic Imaging, Coded Pulse, 3D/4D Inaging mode, Elastography, B-Flow and Combined modes: BM, B/ Color, B/PWD, B/Power/PWD. The Voluson™ SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.
Product codes
IYN, IYO, ITX
Device Description
The subject device is a Track 3 device, primarily intended for general-purpose radiology evaluation and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson SWIFT+ provide digital acquisition, processing and display capability. Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with control panel, full touch monitor, optional image storage and printing devices. It provides high-performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducer including mechanical and electronic scanning transducers which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/Prostate) (TR); Transvaginal (TV).
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
qualified and trained healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician.
hospital or medical clinic.
Description of the training set, sample size, data source, and annotation protocol
Total of 223 volumes were used for training having the following distributions
- Distribution by Systems: Voluson E8 (20), Voluson E10 -(105), Voluson P8 (29), Voluson S10 (48), Voluson S8 (21)
- Distribution by Probes: RIC5-9A-RS (98), RIC5-9-D -(123), RIC6-12-D (2)
- Distribution by Countries: India (62), Germany (29), -United Kingdom (29), Spain (103).
Data is provided by external clinical partners who de-identified the data. Original data is collected in the form of 3D volumes to preserve the flexibility to re-process data retrospectively during scan conversion. To ensure correct and reliable "truthing" process of the training, a curation protocol has been developed by clinical experts to be followed by curators, in addition, during and after the data curation process, a senior sonographer reviewed a random subset of the curated dataset for clinical accuracy.
Description of the test set, sample size, data source, and annotation protocol
Total Datasets: 67
Total follicles count across all volumes : 410
Country: Germany, India, Spain, United Kingdom, USA
Values were obtained from the test pool consisting of 67 volumes, 2 follicles evaluated per volume for a total of 134 follicles.
Mixture of small and large diameter follicles were selected for the evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification for the Auto-Caliper AI feature for 2D caliper placement is performed by clinical experts following a specific protocol :
- Visualization of the follicles on slices parallel to the A plane of acquisition from the datasets
- Click on the follicle on a slice in which the given follicle is expected to be the largest.
- The steps are repeated for all follicles in each volume.
- The output of the caliper placement on the follicles on the plane in which the clinician clicked.
- The outputs are evaluated by the clinical expert and the assessment is documented as Pass/No result/Fail
The success rate of the AI feature is 70% or higher.
The deviation of the measurements predicted by the Auto-Caliper tool from the manual measurements were calculated to obtain the accuracy of the feature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Absolute difference between Al predicted diameter and Ground truth diameter (in mm) | Percentage of data Pool |
|---|---|
| 5.0 | 6.1 |
Predicate Device(s)
K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System
Reference Device(s)
K210438 Versana Premier Diagnostic Ultrasound System, K220358 Voluson E Series Diagnostic Ultrasound System, K213642 Voluson S Series Diagnostic Ultrasound System
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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June 20, 2023
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GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC % Bryan Behn Regulatory Affairs Director 9900 Innovation Dr. WAUWATOSA WI 53226
Re: K230346
Trade/Device Name: Voluson SWIFT: Voluson SWIFT+ Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 16, 2023 Received: May 16, 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Voluson SWIFT, Voluson SWIFT+
Indications for Use (Describe)
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatio; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including UrologyProstate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM (Anatonical M-Mode), PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow (High Definition-Flow), Harmonic Imaging, Coded Pulse, 3D/4D Inaging mode, Elastography, B-Flow and Combined modes: BM, B/ Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson SWIFT+ 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20)
PSC Publishing Sarvices (301) 443-6740 5
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| Date: | February, 8th, 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 214beon-gil, Jungwon-gu, | |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:+1 262-247-5502 | |
| Alternate Contact Person: | Karim Amrouche |
| Senior Regulatory Affairs Manager | |
| GE Healthcare | |
| T: +33620783855 | |
| Device Trade Name: | Voluson SWIFT, Voluson SWIFT+ |
| 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: | K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System |
| Reference Device(s): | K210438 Versana Premier Diagnostic Ultrasound System |
| K220358 Voluson E Series Diagnostic Ultrasound System | |
| K213642 Voluson S Series Diagnostic Ultrasound System | |
| Device Description: | The subject device is a Track 3 device, primarily intended for general- |
| purpose radiology evaluation and specialized for OB/GYN with particular | |
| features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson | |
| SWIFT+ provide digital acquisition, processing and display capability. | |
| Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with | |
| control panel, full touch monitor, optional image storage and printing | |
| devices. It provides high-performance ultrasound imaging and analysis | |
| and have comprehensive networking and DICOM capability. It utilizes a | |
| variety of linear, curved linear, matrix phased array transducer including | |
| Technology: | The Voluson™ SWIFT, Voluson™ SWIFT+ employs the same |
| fundamental scientific technology as its predicate device(s). | |
| Determination of | Comparison to Predicates |
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mechanical and electronic scanning transducers which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic Intended Use: ultrasound system intended for use by qualified and trained healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/Prostate) (TR); Transvaginal (TV). Mode of operation include: B, M, AMM (Anatomical M-Mode), PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow (High Definition-Flow), Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.
Substantial Equivalence: The proposed Voluson SWIFT, Voluson SWIFT+ is a new platform substantially equivalent to the predicate devices. The following is an overview of the differences between the Voluson SWIFT, Voluson SWIFT+ and the predicate Voluson SWIFT, Voluson SWIFT+ (K201828).
- The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The Voluson SWIFT, Voluson SWIFT+ and predicate Voluson SWIFT, Voluson SWIFT+ have the same clinical intended use.
- . The Voluson SWIFT, Voluson SWIFT+ and predicate Voluson SWIFT, Voluson SWIFT+ have the similar imaging modes with the exception that the proposed Voluson SWIFT, Voluson
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SWIFT+ does not include the attenuation imaging mode.
-
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 SWIFT, Voluson SWIFT+ and predicate Voluson SWIFT, Voluson SWIFT+ systems have similar capability in terms of performing measurements, capturing digital images, reviewing, and reporting studies.
-
The proposed Voluson SWIFT, Voluson SWIFT+ and predicate ● Voluson SWIFT. Voluson SWIFT+ systems have been designed in compliance with approved electrical and physical safety standards.
-
The probes supported in the proposed Voluson SWIFT, Voluson SWIFT+ and predicate Voluson SWIFT, Voluson SWIFT+ are identical except:
-
The addition of a new transducer 9L-RS (already cleared on predicate Versana Premier K210438).
-
The addition of a new transducer 12S-RS (already cleared on predicate Versana Premier K210438).
-
The absence of the E8C-RS transducer on the proposed Voluson SWIFT, Voluson SWIFT+
-
The following software features have been added compared to the ● predicate Voluson SWIFT, Voluson SWIFT+ (K201828) : Shadow Reduction Button, Autolive, RadiantFlow, Volume with color, SpineTrace, Fractional Limb Volume, Timer for BPP, Fetal Heart Support, SonoPelvicFloor, Auto-Caliper, Reminders, SW Download, AVURI
-
The following software features have been migrated from Voluson ● E series (K220358): Shadow Reduction, Fetal Heart Support, SonoPelvicFloor, SW download, AVURI
-
The following software features have been migrated from Voluson ● S Series (K213642) : Radiantflow, Volume with color, Fractional Limb Volume.
-
The proposed Voluson SWIFT, Voluson SWIFT+ adds the ● following new features: Autolive, Spine Trace, Time for BPP (Biophysical Profile), Auto-Caliper, reminders.
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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, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson SWIFT, Voluson SWIFT+ complies with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: ● General Requirements for Safety, 2005/(R)2012 And A1:2012
- 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 4.0. 2014
- 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, Fourth edition, 2009
- ISO 14971, Application of risk management to medical devices, ● 2007
- NEMA PS 3.1 3.20, Digital Imaging and Communications in ● Medicine (DICOM) Set. (Radiology), 2016
- 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
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.
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Summary of Clinical Tests:
The subject of this premarket submission, Voluson SWIFT, Voluson SWIFT+, did not require clinical studies to support substantial equivalence.
AI Verification Summary
Auto-Caliper:
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 verification for the Auto-Caliper AI feature for 2D caliper ● placement is performed by clinical experts following a specific protocol :
- Visualization of the follicles on slices parallel to the A plane of ● acquisition from the datasets
- . Click on the follicle on a slice in which the given follicle is expected to be the largest.
- The steps are repeated for all follicles in each volume. ●
- The output of the caliper placement on the follicles on the plane in which the clinician clicked.
- The outputs are evaluated by the clinical expert and the assessment is documented as Pass/No result/Fail
- The success rate of the AI feature is 70% or higher
Data Collection and Distribution:
- Total Datasets: 67
- Total follicles count across all volumes : 410
- Country: Germany, India, Spain, United Kingdom, USA
Quantitative evaluation:
- Values were obtained from the test pool consisting of 67 volumes, 2 follicles evaluated per volume for a total of 134 follicles.
- Mixture of small and large diameter follicles were selected for the ● evaluation
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Image /page/8/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 blue circle. Three curved shapes surround the circle, adding a sense of motion or energy to the design. The logo is simple, recognizable, and represents the brand identity of General Electric.
-
. The deviation of the measurements predicted by the Auto-Caliper tool from the manual measurements were calculated to obtain the accuracy of the feature.
Demographic distribution, gender, age and ethnicity : -
. Data acquired from women examined in regular clinical practice In compliance with privacy health information.
-
Data acquired from 6 countries and five systems to ensure sufficient diversity.
Information about clinical subgroups and confounders :
- . Data collected from multiple system configurations and different probes from multiples geographical sites.
- . The acquired datasets have a variation in shapes and size of the follicles having diameters ranging from 2mm to 25 mm.
- Data acquired from 6 countries and five systems to ensure ● sufficient diversity.
Equipments and protocols :
- Data is provided by external clinical partners who de-identified the data.
- . Original data is collected in the form of 3D volumes to preserve the flexibility to re-process data retrospectively during scan conversion.
- A total of 223 volumes were used for training having the ● following distributions
- Distribution by Systems: Voluson E8 (20), Voluson E10 -(105), Voluson P8 (29), Voluson S10 (48), Voluson S8 (21)
- Distribution by Probes: RIC5-9A-RS (98), RIC5-9-D -(123), RIC6-12-D (2)
- Distribution by Countries: India (62), Germany (29), -United Kingdom (29), Spain (103).
Information about the reference standard and dataset ("truthing process"):
- Datasets contained in the collections for training and verification are mutually exclusive and stem from a mutually exclusive list of patients.
- Data has been collected from patients from regular clinical ● practice from multiple sites thereby capturing the actual representative population. There is no explicit bias/preference enforced during the collection process.
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Image /page/9/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 blue circle. The circle is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.
- To ensure correct and reliable "truthing" process of the training, a curation protocol has been developed by clinical experts to be followed by curators, in addition, during and after the data curation process, a senior sonographer reviewed a random subset of the curated dataset for clinical accuracy.
| Absolute difference between Al predicted
| diameter and Ground truth diameter (in mm) | Percentage of data Pool |
|---|---|
| 5.0 | 6.1 |
- Conclusion: GE Healthcare considers the Voluson SWIFT, Voluson SWIFT+ to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).