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: Fetall 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 Voluson™ Expert 18, Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

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.

AI/ML Overview

The provided document describes the predicate devices as the Voluson Expert 18, Voluson Expert 20, Voluson Expert 22. The K-number for the primary predicate device is K231965. The document does NOT describe the acceptance criteria or study that proves the device meets the acceptance criteria for those predicate devices. Instead, it details the testing and acceptance criteria for new or updated AI software features introduced with the new Voluson Expert Series devices (K242168).

Here's a breakdown of the requested information based on the AI testing summaries provided for the new/updated features: Sono Pelvic Floor 3.0 (MHD and Anal Sphincter), SonoAVC Follicle 2.0, and 1st/2nd Trimester SonoLyst/SonoLystlive.

Acceptance Criteria and Device Performance for New/Updated AI Features

1. Table of Acceptance Criteria and Reported Device Performance

AI Feature	Acceptance Criteria	Reported Device Performance
Sono Pelvic Floor 3.0 (MHD)	MHD Tracking, Minimum MHD Frame Detection, Maximum MHD Frame Detection:- On datasets marked as "Good Image Quality": success rate should be 70% or higher.- On datasets marked as "Challenging Image Quality": success rate should be 60% or higher. Overall MHD:- On "Good IQ" datasets: 70% or higher. - On "Challenging Quality" datasets: 60% or higher.	MHD Tracking:- Good Image Quality: 89.3%- Challenging Image Quality: 77.7%Minimum MHD Frame Detection:- Good Image Quality: 89.3%- Challenging Image Quality: 83.3%Maximum MHD Frame Detection:- Good Image Quality: 90.66%- Challenging Image Quality: 77.7%Overall MHD:- On Good IQ datasets: 81.9%- On Challenging quality datasets: 60.9%
Sono Pelvic Floor 3.0 (Anal Sphincter)	- On datasets marked as "Good Image Quality": success rate should be 70% or higher.- On datasets marked as "Challenging Image Quality": success rate should be 60% or higher.	The document states "Verification results on actual verification data is as follows" but then the table structure is missing the actual performance metrics for Anal Sphincter. It only lists "On Good IQ datasets: 81.9%" and "On Challenging quality datasets: 60.9%" under the MHD section, implying those might be overall success rates for the entire Sono Pelvic Floor 3.0 feature across both components, but it's not explicitly clear. Therefore, the specific reported device performance for "Anal Sphincter" is not clearly presented in the provided text.
SonoAVC Follicle 2.0	- The success rate for the AI feature should be 70% or higher. (This appears to be an overall accuracy criterion).	Accuracy:- On test data acquired together with train cohort: 94.73%- On test data acquired consecutively post model development: 92.8%- Overall Accuracy: 93.6%Dice Coefficient by Size Range:- 3-5 mm: 0.937619- 5-10 mm: 0.946289- 10-15 mm: 0.962315- >15 mm: 0.93206
1st Trimester SonoLyst/SonoLystLive	- The average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL and overall traffic light accuracy is 80% or higher.	The document states "The average success rate...is 80% or higher" as the acceptance criteria and then mentions "Data used for both training and validation has been collected across multiple geographical sites..." but it does not explicitly provide the numerically reported device performance value that met or exceeded the 80% criterion.
2nd Trimester SonoLyst/SonoLystLive	- Acceptance criteria are met for both subgroups (variety of ultrasound systems/data formats vs. target platform). (The specific numerical criteria for acceptance are not explicitly stated, but rather that the performance met them for demonstration of generalization.)	The document states "For both subgroups the acceptance criteria are met." but does not explicitly provide the numerically reported device performance values.

2. Sample Sizes Used for the Test Set and Data Provenance

Sono Pelvic Floor 3.0 (MHD & Anal Sphincter):
- Test Set Sample Size: 93 volumes for MHD, 106 volumes for Anal Sphincter.
- Data Provenance: Data is provided by external clinical partners who de-identified the data. Original data collected in 4D volume Cines (*.vol5 or *.4dv6) or 4D/3D volume acquisitions (*.vol2 or *.4dv3).
- Countries: A diverse range of countries contributed to the test data including Italy, U.S.A, Australia, Germany, Czech Republic, France, India (for MHD); and Italy, U.S.A, France, Germany, India (for Anal Sphincter).
- Retrospective/Prospective: The data collection method ("re-process data to our needs retrospectively during scan conversion") suggests a retrospective approach to assembling the dataset, although a "standardized data collection protocol was followed for all acquisitions." New data was also acquired post-model development from previously unseen sites to test robustness.
SonoAVC Follicle 2.0:
- Test Set Sample Size: 138 datasets, with a total follicle count of 2708 across all volumes.
- Data Provenance: External clinical partners provided de-identified data in 3D volumes (*.vol or *.4dv).
- Countries: Germany, India, Spain, United Kingdom, USA.
- Retrospective/Prospective: The data was split into train/validation/test at the start of model development (suggesting retrospective). Additionally, consecutive data was acquired post-model development from previously unseen systems and probes to test robustness (suggesting some prospective element for this later test set).
2nd Trimester SonoLyst/SonoLystLive:
- Test Set Sample Size: "Total number of images: 2.2M", "Total number of cine loops: 3595". It's not explicitly stated how much of this was test data vs. training data, but it implies a large dataset for evaluation.
- Data Provenance: Systems used for data collection included GEHC Voluson V730, E6, E8, E10, Siemens S2000, and Hitachi Aloka. Formats included DICOM & JPEG for still images and RAW data for cine loops.
- Countries: UK, Austria, India, and USA.
- Retrospective/Prospective: Not explicitly stated, but "All training data is independent from the test data at a patient level" implies a pre-existing dataset split rather than newly acquired prospective data solely for testing.
1st Trimester SonoLyst/SonoLystLive:
- Test Set Sample Size: SonoLyst 1st Trim IR: 5271 images, SonoLyst 1st Trim X: 2400 images, SonoLyst 1st Trim Live: 6000 images, SonoBiometry CRL: 110 images.
- Data Provenance: Systems included GE Voluson V730, P8, S6/S8, E6, E8, E10, Expert 22, Philips Epiq 7G. Formats included DICOM & JPEG for still images and RAW data for cine loops.
- Countries: UK, Austria, India, and USA.
- Retrospective/Prospective: "All training data is independent from the test data at a patient level." "A statistically significant subset of the test data is independent from the training data at a site level, with no test data collected at the site being used in training." This indicates a retrospective collection with careful splitting, and some test data from unseen sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Sono Pelvic Floor 3.0 (MHD & Anal Sphincter), SonoAVC Follicle 2.0, 2nd Trimester SonoLyst/SonoLystLive, 1st Trimester SonoLyst/SonoLystLive:
- Number of Experts: Three independent reviewers.
- Qualifications: "at least two being US Certified sonographers, with extensive clinical experience."
Additional for 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive:
- For sorting/grading accuracy review, a "5-sonographer review panel" was used. Qualifications are not specified beyond being sonographers.

4. Adjudication Method for the Test Set

Sono Pelvic Floor 3.0 (MHD & Anal Sphincter), SonoAVC Follicle 2.0, 2nd Trimester SonoLyst/SonoLystLive, 1st Trimester SonoLyst/SonoLystLive:
- The evaluation was "based on interpretation of the AI output by reviewing clinicians." The evaluation was "conducted by three independent reviewers."
- For 2nd and 1st Trimester SonoLyst/SonoLystLive, where sorting/grading accuracy was determined, if initial sorting/grading differed from the ground truth (established by a single sonographer then refined), a 5-sonographer review panel was used, and reclassification was based upon the "majority view of the panel." This implies a form of majority vote adjudication for these specific sub-tasks.
- The general approach for the three reviewers, especially when evaluating AI output, implies an independent review, and while not explicitly stated, differences would likely lead to discussion or a form of consensus/adjudication. However, a strict 'X+Y' model (like 2+1 or 3+1) is not explicitly detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study designed to measure how human readers improve with AI vs. without AI assistance. The studies described are primarily aimed at assessing the standalone performance or workflow utility of the AI features.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, standalone performance was assessed for all described AI features. The "Summary test Statistics" and "Verification Results" sections for each feature (Sono Pelvic Floor 3.0, SonoAVC Follicle 2.0, 1st/2nd Trimester SonoLyst/SonoLystLive) report the algorithm's direct performance (e.g., success rates, accuracy, Dice coefficient) against the established ground truth, indicating standalone evaluation. The "interpretation of the AI output by reviewing clinicians" method primarily focuses on validating the AI's direct result rather than a comparative human performance study.

7. The Type of Ground Truth Used

Expert Consensus/Annotation:
- Sono Pelvic Floor 3.0 (MHD): Ground truth was established through a "two-stage curation process." Curators identified the MHD plane and marked anatomical structures. These curated datasets were then "reviewed by expert arbitrators."
- Sono Pelvic Floor 3.0 (Anal Sphincter): Ground truth involved "3D segmentation of the Anal Canal using VOCAL tool in the 4D View5 Software." Each volume was "reviewed by a skilled arbitrator for correctness."
- SonoAVC Follicle 2.0: The "Truthing process for training dataset" indicates a "detailed curation protocol (developed by clinical experts)" and a "two-step approach" with an arbitrator reviewing all datasets for clinical accuracy.
- 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive: Ground truth for sorting/grading was initially done by a single sonographer, then reviewed by a "5-sonographer review panel" for accuracy, with reclassification based on majority view if needed.

8. The Sample Size for the Training Set

Sono Pelvic Floor 3.0 (MHD): Total Volumes: 983
Sono Pelvic Floor 3.0 (Anal Sphincter): Total Volumes: 828
SonoAVC Follicle 2.0: Total Volumes: 249
2nd Trimester SonoLyst/SonoLystLive: "Total number of images: 2.2M", "Total number of cine loops: 3595". (The precise breakdown of training vs. test from this total isn't given for this feature, but it's a large overall dataset).
1st Trimester SonoLyst/SonoLystLive: 122,711 labelled source images from 35,861 patients.

9. How the Ground Truth for the Training Set Was Established

Sono Pelvic Floor 3.0 (MHD): A two-stage curation process. First, curators identify the MHD plane and then mark anatomical structures. These curated datasets are then reviewed by expert arbitrators and "changes/edits made if necessary to maintain correctness and consistency in curations."
Sono Pelvic Floor 3.0 (Anal Sphincter): "3D segmentation of the Anal Canal using VOCAL tool in the 4D View5 Software." Curation protocol involved aligning the volume and segmenting the Anal Canal. Each volume was "reviewed by a skilled arbitrator for correctness."
SonoAVC Follicle 2.0: A "two-step approach" was followed. First, curators were trained on a "detailed curation protocol (developed by clinical experts)." Second, an automated quality control step confirmed mask/marking availability, and an arbitrator reviewed all datasets from each curator's completed data pool for clinical accuracy, with inconsistencies discussed by the curation team.
2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive: The images were initially "curated (sorted and graded) by a single sonographer." If these differed from the ground truth (which implies a higher standard or previous ground truth for comparison), a "5-sonographer review panel" reviewed them and reclassified based on majority view to achieve the final ground truth.

Summary

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December 20, 2024

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 seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

GE Medical Systems Ultrasound and Primary care Diagnostics Bryan Behn Regulatory Affairs Director 9900 Innovation Drive Wauwatosa, Wisconsin 53226

Re: K242168

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 Trade/Device Name: Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: November 18, 2024 Received: November 18, 2024

Dear Behn Bryan:

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/cfpm/pm.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).

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

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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system.

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-reporting-mdr-how-report-medicaldevice-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-deviceadvice-comprehensive-regulatory-assistance/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

Submission Number (if known)

K242168

Device Name

Voluson Expert 18: Voluson Expert 20;

Voluson Expert 20,
Voluson Expert 22

Voluson Expert 22

Indications for Use (Describe)

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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K242168

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	July 24, 2024
Submitter:	GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871
Primary ContactPerson:	Bryan BehnRegulatory Affairs DirectorGE Healthcare9900 Innovation Drive,Wauwatosa, WI 53226USAT:(262)247-5502F:(414)918-8275
Secondary ContactPerson:	Thomas ReisenbergerSr. Regulatory Affairs LeaderGE Healthcare Austria GmbH & Co OGT:(+43)7682-3800-332F:(+43)7682 3800-47
Device: TradeName	Voluson Expert SeriesModels: Voluson Expert 18, Voluson Expert 20, Voluson Expert 22
Common/UsualName:	Ultrasound system
ClassificationNames:Product Code:	Class IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary PredicateDevice(s):	K231965 Voluson Expert 18, Voluson Expert 20, Voluson Expert 22Diagnostic Ultrasound System

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510(k) Premarket Notification Submission

Classification	Class II
Names:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Product Code:
Reference	K231301 Vscan Air
Predicatee	K211488 Logiq E10
Device(s):	K240111: Venue

Class II
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Classification Names: Product Code:

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, RIC12-D. The RAB7-D is a new probe and is substantially equivalent to the

RAB6-D, it is an incremental improvement in technology. Vscan Air SL and Vscan Air CL wireless Probes are also added.

The device is a general purpose ultrasound system intended for use by Intended Use: qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared:
Abdominal (including GYN, pelvic and infertility Fetal/OB; 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

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510(k) Premarket Notification Submission

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 Voluson™ Expert 18, Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

The Voluson Expert Series (Voluson Expert 18/20/22) employs the Technology: same fundamental scientific technology as its predicate devices.

Determination of Comparison to Predicates

Substantial The proposed Voluson Expert 18/20/22 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 eM6C G3, 4d realtime Probes: RIC6-12-D, and RM7C. 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 18/20/22 and predicate Voluson Expert 18/20/22 systems have the same clinical intended use.
The proposed Voluson Expert 18/20/22 and predicate Voluson Expert 18/20/22 systems have the same imaging modes.
� The proposed Voluson Expert 18/20/22 and predicate Voluson Expert 18/20/22 system transducers are equivalent. New RAB7-D and VscanAir SL and VscanAir CL wireless probes were 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.

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The proposed Voluson Expert Series 18/20/22 and predicate . Expert 18/20/22 system have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The proposed Voluson Expert Series 18/20/22 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
There proposed Voluson Expert Series 18/20/22 and predicate ● Expert 18/20/22 system Software Features are equivalent (except below Changes). Some minor improvements to the existing Software features have been implemented into the proposed system.
The proposed Voluson Expert Series 18/20/22 adds additional AI software features SonoLyst 1st Trimester and Sono Pelvic floor 3.0: which includes MHD (valsava manoeuver detection) and Anal sphincter
. The proposed Voluson Expert Series 18/20/22 updated existing AI software features SonoLyst 2nd Trimester and SonoAVC follicle 2.0
The proposed Voluson Expert Series 18/20/22 adds additional software features
- O-RADS=(Ovarian-Adnexal Reporting & Data System) o
- OTI live, Automation of bulk speed of sound о implemented (similar method as existing ADAPT with eM6C)
The following software feature has been migrated from Venue ● (K240111): Vscan Air Probe Support
. The proposed Voluson Expert Series 18/20/22 adds one new Probe: RAB7-D which is similar to predicate probe RAB6-D (K231965) and support of wireless Probes Vscan Air CL and Vscan Air SL Probes (K240111):

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Image /page/7/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 purple and features a stylized "GE" in a circular design. The text "GE HealthCare" is also purple and is written in a clean, sans-serif font.

GE HealthCare 510(k) Premarket Notification Submission

AI Testing Summary for new Sono Pelvic floor 3.0: which includes MHD (valsava manoeuver detection) and Anal sphincter:

	MHD		Anal Sphincter
	Expected result.		Expected result.
	On datasets that weremarked as Good inImage/Cine Qualityassessment, the successrate should be 70% orhigher. On datasets thatwere marked aschallenging in image/cinequality measure thesuccess rate of the featureshould be 60% or higher.		On datasets that weremarked as Good inImage/Cine Qualityassessment, the success rateshould be 70% or higher. Ondatasets that were marked aschallenging in image/cinequality measure the successrate of the feature should be60% or higher.
	Rationale for clinicaladequacy.		Rationale for clinicaladequacy.
SummarytestStatistics	Requirements for successrates of this workflow toolwere discussed withinternal and externalclinical experts. Userscanning experience andexpected image quality inclinical practice wasconsidered and reflected inthe verification data pool.Based on the expertopinion the above successrates were consideredappropriate.Verification Results onactual verification data isas follows		Requirements for successrates of this workflow toolwere discussed with internaland external clinical experts.User scanning experienceand expected image qualityin clinical practice wasconsidered and reflected inthe verification data pool.Based on the expert opinionthe above success rates wereconsidered appropriate.Verification results on actualverification data is as follows
	MHD TrackingMinimum MHDFrame DetectionMaximum MHDFrame detection	Good ImageQuality89.3%89.3%90.66%	ChallengingImage Quality77.7%83.3%77.7%
	On Good IQ datasets: 81.9%
		On Challenging qualitydatasets: 60.9%
	The primary confounderspresent in the data poolare as follows:	Confounder:
Confounders	1. Phase of examination:Rest, Contraction andValsalva	1. Multiple probes (bothTransabdominal andtransvaginal) are representedin the verification pool asdetailed above.
	2. Multiple probes (bothTransabdominal andtransvaginal) arerepresented in theverification pool as detailedabove.	2. The data is acquired acrossdiverse regions and sites
	3. The data is acquiredacross diverse regions andsites	3. There is also image qualityvariation in the data sets -marked as challenging orgood IQ by clinical experts.
	4. There is also imagequality variation in the datasets – marked aschallenging or good IQ byclinical experts.

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GE HealthCare

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Image /page/9/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 purple and features a stylized design. The text is also purple and is written in a sans-serif font.

GE HealthCare 510(k) Premarket Notification Submission

	Data is provided byexternal clinical partnerswho de-identified the databefore sharing it with us.Original data is collected inthe form of 4D volumeCines in .vol5 or .4dv6data formats. Thispreserves the flexibility tore-process data to ourneeds retrospectivelyduring scan conversion7. Astandardized datacollection protocol wasfollowed for allacquisitions.	Data is provided by externalclinical partners who de-identified the data beforesharing it with us. Originaldata is collected in the formof 4D or 3D volumeacquisitions in .vol2 or.4dv3 data formats. Thispreserves the flexibility to re-process data to our needsretrospectively during scanconversion4. A standardizeddata collection protocol wasfollowed for all acquisitions.
	Distribution of train data isas follows	Distribution of train data isas follows
	Total Volumes: 983	Total Volumes: 828
DataCollection	Distribution by Systems:	Distribution by Systems:
	V730 (116), Voluson E10(482), Voluson E6 (21),Voluson E8 (90), VolusonP8 (274)	Voluson E6 (118), V730 (160),Voluson E10 (149), VolusonS10 (120), Voluson SWIFT(28), Voluson E8 (83),Voluson P8 (155), Voluson S8(8), SWIFT + (7)
	Distribution by Probes: RAB4-8L (116), RAB2-6-RS (38),RAB6-D (111), RIC5-9A-RS(236), RIC5-9-D (8), RM6C(474)	Distribution by Probes: RAB4-8L (160), RAB6 (409) RIC5-9(132), RM7C (42), em6C (2),RM6C (83)
	Distribution by Countries:Australia (116), Austria (8),Belgium (465), CzechRepublic (100), Japan (236),Italy (37), South Africa (21)Distribution of Test data isas follows	Distribution by Countries:Belgium (116), Australia(186), Egypt (136), Japan(132), Germany (125), SouthAfrica (124), Italy (9)Distribution of Test data is asfollows
	Total Volumes: 93	Total Volumes: 106
	Distribution by Systems:Voluson Expert 22 (59),Voluson Expert 20 (4), V730(5), Voluson E10 (12),Voluson E8 (2), VolusonS10 (10), Voluson Signature20 (1)	Distribution by Systems:Voluson E10 (37), VolusonExpert 22 (57), VolusonExpert 20 (7), VolusonSignature 20 (5)
	Distribution by Probes:RAB6-D (21), RIC5-9-D (14),RM7C (26), RAB 4-8L (5),RIC10-D (21), RM6C (6)	Distribution by Probes: RAB6-D (12), RAB7-D (2), RIC10-D(9), RIC5-9 (62), RM6C (2),RM7C (19)
	Distribution by Countries:Italy (21), U.S.A (29),Australia (5), Germany (15),Czech Republic (6), France(2), India (15)	Distribution by Countries:Italy (21), U.S.A (18), France(32), Germany (12), India(23)
Truthingprocessfortrainingdatasets	We undertake a two-stagecuration process. In thefirst stage, curators identifythe MHD plane in therelevant frame of the cine.In the next stage, theanatomical structures aremarked on the MHD plane.The curated datasets arereviewed by expertarbitrators andchanges/edits made ifnecessary to maintaincorrectness andconsistency in curations,	We undertake a 3Dsegmentation of the AnalCanal using VOCAL tool in the4D View5 Software. Curationprotocol is as follows:1. Align the volume to ensurefull visualization of the AnalCanal2. Segment the Anal Canal in3D using VOCAL tool.Curation is done on onlyvolumes that have propervisualization of the relevantanatomyEach volume was reviewedby a skilled arbitrator forcorrectness. If any error wasfound, the volume was re-worked
Truthingprocessfor Testdatasets	For Evaluation pool:The evaluation was basedon interpretation of the Aloutput by reviewingclinicians. The evaluationwas conducted by three	For Evaluation pool:The evaluation was based oninterpretation of the Aloutput by reviewingclinicians. The evaluation wasconducted by three
	independent reviewers,with at least two being USCertified sonographers,with extensive clinicalexperience.	independent reviewers, withat least two being USCertified sonographers, withextensive clinical experience.
	To ensure separation oftrain and test data,following steps wereundertaken:	To ensure separation of trainand test data, following stepswere undertaken:
Independence ofTest data	Post model development,we acquired consecutivedata from previouslyunseen sites to test therobustness of the algorithmon new data distributions.We also collectedconsecutive data(separately) from sites thathad contributed to thetrain pool as well.	Post model development, weacquired data frompreviously unseen (in trainpool) systems as well asnew/unseen sites to test therobustness of the algorithmon new data distributions.

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Image /page/10/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the letters "GE" enclosed in a circle. The text "GE HealthCare" is written in a simple, sans-serif font and is colored purple.

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Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a purple circle with the letters "GE" in a stylized script in the center. The letters are white. There are three white teardrop shapes around the edge of the circle, evenly spaced.

GE HealthCare

510(k) Premarket Notification Submission

AI Testing Summary for updated feature SonoAVC Follicle 2.0:

	SonoAVC Follicle 2.0
	Expected resultThe success rate for Al feature should be 70% orhigher.
Summary testStatistics	Rational for Clinical AdequacyRequirements for success rates of this workflow toolexperts. User scanning experience and expected imagequality in clinical practice was considered and reflectedin the verification data pool. Based on the expertopinion the above success rates were consideredappropriate.
	Verification Results on actual verification data is asfollows:
	Accuracy:On test data acquired together with train cohort:94.73%
	On test data, acquired consecutively post modeldevelopment: 92.8%Overall Accuracy: 93.6%

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Image /page/12/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 purple and features a stylized "GE" design. The text "GE HealthCare" is also purple and is written in a clean, sans-serif font.

Confounders	For various confounders the individual accuracy numbers are as follows:Probe wise distribution:RIC5-9 – 94.6%RIC10 – 93,6%RIC6-12 – 90.6%Geographical distribution:Germany - 92.2%India – 95.1%Spain - 94.7%U.K. - 95.5%
	The test cohort consists of multiple sets - Set 1 is acquired together with the train data set and remaining sets (2-5) are acquired post model development.For set 1 – the size distribution of follicles (measured as the largest 3D diameter) is detailed below:3-5 mm: 31%5-10 mm: 40%10-15 mm: 21%>15 mm: 8%The above is in line with the clinical prevalence of the follicle sizes.The above, together with data from diverse probes and different sites ensure sufficient diversity is captured in terms of acquisition settings, image quality as well as patient demographics.The performance matrix for the various size ranges for follicles is as follows. Size Range (mm) Dice Coefficient 3-5 0.937619 5-10 0.946289 10-15 0.962315 >15 0.93206

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Image /page/13/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the letters "GE" inside a circle with decorative flourishes. The text "GE HealthCare" is written in a simple, sans-serif font.

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 3D volumes in .vol¹ or .4dv² data formats. This preserves the flexibility to re-process data to our needs retrospectively during scan conversion³.Train Data Distribution:Total Volumes: 249 Distribution by Systems: Voluson E8 (20), Voluson E10 (131), Voluson P8 (29), Voluson S10 (48), Voluson S8 (21) Distribution by Probes: RIC5-9A-RS (98), RIC5-9-D (149), RIC6-12-D (2) Distribution by Countries: India (62), Germany (29), United Kingdom (29), Spain (103) Test Data DistributionTotal Datasets: 138Total follicle count across all volumes: 2708 Distribution by Systems: Voluson E22 (63), E10 (32), Voluson E8 (20), Voluson P8 (8), Voluson S10 (12), Voluson S8 (3) Distribution by Probes: RIC5-9 (84), RIC10 (37), RIC6-12 (17) Distribution by Countries: Germany (54), India (11), Spain (43), United Kingdom (7); USA (23)
Truthing processfor training dataset	To ensure correct and reliable "truthing" process of the training data we followed a two-step approach.In the 1st step, a detailed curation protocol (developed by clinical experts) was shared with the curators, and they were trained and instructed to follow the same.As an automated quality control step, we confirm the availability of all the required masks/markings in each of the curated views. Missing masks or inconsistent labels are reported back to the curators and the datasets not used for training/development until all masks are available and consistently labelled.In addition, during and after the data curation process, a arbitrator reviews all the datasets and curations from each curator's completed data pool for their clinical accuracy. In case that any inconsistencies are detected, an optimal curation strategy is discussed and communicated back to the entire curation team.
Truthing processfortest data	For Evaluation pool:The evaluation was based on interpretation of the AIoutput by reviewing clinicians. The evaluation wasconducted by three independent reviewers, with atleast two being US Certified sonographers, withextensive clinical experience.
Independence ofTest data	To ensure separation of train and test data, followingsteps were undertaken:1. Post acquiring the data at the start of themodel development – the entire data poolwas split into train / validation and testdatasets ensuring that there is uniqueness inthe patient representation in each set - i.e. asingle patient is present only in one of thethree groups. Also, it was attempted thatthere is a representation of as manygeographical sites as possible in both the testand train pool. Beyond these two constraints,the data was split randomly.2. Post model development, we acquiredconsecutive data from previously unseen (intrain pool) systems as well as new/unseenprobe to test the robustness of the algorithmon new data distributions.

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Image /page/14/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is a shade of purple.

510(k) Premarket Notification Submission

AI Testing Summary for updated feature 2nd Trimester SonoLyst/SonoLystlive

SonoLyst/SonoLystlive
1230

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Image /page/15/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with the letters 'GE' intertwined in a stylized font. To the right of the emblem, the words 'GE HealthCare' are written in a simple, sans-serif font. The color of the logo is a shade of purple.

Confounders	In order to demonstrate the generalizationperformance of the algorithm, the quantitativeevaluation is performed for two subgroups: a data setcontaining of a variety of ultrasound systems and dataformats against a data set containing the targetplatform. For both subgroups the acceptance criteriaare met.
Data Collection	Systems: GEHC Voluson V730, E6, E8, E10,Siemens S2000 and Hitachi AlokaFormats: Still images were obtained in DICOM& JPEG format, cine loops in RAW dataformat.Countries: UK, Austria, India and USATotal number of images: 2.2MTotal number of cine loops: 3595
	To ensure the quality of the curated data forverification, the following strategy is employed:employed1. The images were curated (sorted and graded)by a single sonographer2. The images were sorted and graded by
	ScanNav AutoCapture Second Trimester.This process resulted in some images beingreclassified during sorting.
Truthing processfor trainingdatasets	3. Where they differed from the ground truth,the sorted images from step 2 were reviewedby a 5-sonographer review panel, in order todetermine the sorting accuracy of the system.The sorting process resulted in some imagesbeing reclassified based upon the majorityview of the panel.
	4. Where they differed from the ground truth,the graded images from step 1 were reviewedby a 5-sonographer review panel, in order todetermine the grading accuracy of the system.

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Image /page/16/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram inside of a circle on the left, and the words "GE HealthCare" on the right. The logo is purple.

510(k) Premarket Notification Submission

Truthing processfor Test datasets	For Evaluation pool:The evaluation was based on interpretation of the Aloutput by reviewing clinicians. The evaluation wasconducted by three independent reviewers, with atleast two being US Certified sonographers, withextensive clinical experience.
Independence ofTest data	All training data is independent from the test data at apatient level.

AI Testing Summary for updated feature 1st Trimester SonoLyst/Sonolystlive

	1st Trimester SonoLyst/SonolysLive
Summary testStatistics	Data used for both training and validation has• been collected across multiple geographicalsites using different systems to represent thevariations in target population.The verification for the SonoLyst 1st Trim IR&X• feature is based on computing confusionmatrices for the sorting (SonoLyst IR) andgrading (SonoLyst X) featuresThe verification of the SonoLystLive 1st Trim• Trimester features is based on the averageagreement between a sonographer panel andthe output of the algorithm regarding Trafficlight quality (green/amber/none)The verification of the SonoBiometry CRL• feature is based on the acceptability rate forthe placement of CRL callipersThe average success rate of SonoLyst 1st• Trimester IR, X and SonoBiometry CRL andoverall traffic light accuracy is 80% or higher
Confounders	For SonoLyst 1st Trimester the following confounder isused: the algorithmic performance is tested on twosub data sets: 1) data acquired with transabdominalprobes 2) data acquired with transvaginal probes. Bychoosing transabdominal vs transvaginal probes asconfounder for the data analysis, the robustness of thealgorithm against the influence of the abdominal wall,the transducer geometry and frequency is evaluated.For both subgroups the acceptance criteria are met.This demonstrates the generalization performance ofthe algorithm.

Data Collection	- Systems: GE Voluson V730, P8, S6/S8, E6, E8,E10, Expert 22, Philips Epiq 7G- Formats: Still images were obtained in DICOM& JPEG format, cine loops in RAW dataformat.- Countries: UK, Austria, India and USA- For training 122,711 labelled source imagesfrom 35,861 patients- For testing the following number of imageswere used:SonoLyst 1st Trim IR: 5271SonoLyst 1st Trim X: 2400SonoLyst 1st Trim Live: 6000SonoBiometry CRL: 110
Truthing processfor test datasets	To ensure the quality of the curated data forverification, the following strategy is employed:employed1. The images were curated (sorted and graded)by a single sonographer2. The images were sorted and graded byScanNav AutoCapture First Trimester.This process resulted in some imagesbeing reclassified during sorting.3. Where they differed from the ground truth,the sorted images from step 2 werereviewed by a 5-sonographer reviewpanel, in order to determine the sortingaccuracy of the system.The sorting process resulted in some imagesbeing reclassified based upon the majorityview of the panel.4. Where they differed from the ground truth,the graded images from step 1 werereviewed by a 5-sonographer reviewpanel, in order to determine the gradingaccuracy of the system.
Independence ofTest data	All training data is independent from the test data at apatient level.A statistically significant subset of the test data isindependent from the training data at a site level, withno test data collected at the site being used in training.

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Image /page/17/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 purple and features a stylized "GE" in a circular design, while the text is also purple and uses a clean, sans-serif font.

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Image /page/18/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 purple and features a stylized "GE" in a circular design, while the text is also purple and written in a clean, sans-serif font.

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 18/20/22 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 (2023e), Digital Imaging and . Communications in Medicine (DICOM) Set. (Radiology)
AAMI TIR69:2017/(R2020), Risk management of radiofrequency wireless coexistence for medical devices and systems
. IEC62359 Edition 2.1 2017-09 Consolidated Version; Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

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) ●

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Image /page/19/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, and the text is in a sans-serif font and is purple.

510(k) Premarket Notification Submission

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson Expert Series 18/20/22 did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Voluson Expert Series 18/20/22 to be as safe, as effective, and performance is substantially equivalent to the primary predicate device.

Regulation Number and Section

§ 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.