Venue Go by GE Medical Systems Ultrasound and Primary Care Diagnostics

The Venue Go is a general purpose diagnostic ultuse by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Device Description

Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time. The Venue Go utilizes a varietv of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Venue Go ultrasound system. It includes a specific section detailing the AI feature cNerve. Based on this information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve AI Feature)

Acceptance Criterion (cNerve)	Reported Device Performance (cNerve)
Overall cNerve Performance (Sequence Accuracy)
At least 70% of the sequences are meaningfully detected.	Performance not explicitly stated as a percentage for "meaningfully detected sequences" in the provided document, but implied by the "successfully detected" metric.
At least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria).	The document states performance requirements, but the actual achieved performance data (e.g., "cNerve achieved X% of meaningfully detected sequences" or "cNerve successfully detected Y% of these") against these specific criteria are not numerically reported in the "AI Summary of Testing" section. It only states what the performance requirements are, not what was measured against those requirements.
Pixel Accuracy in Frames (Specific thresholds for appropriate intended use derived from preliminary survey)	Specific numerical thresholds for pixel accuracy are not provided in the document.
Frame Accuracy in Sequences (Specific thresholds for appropriate intended use derived from preliminary survey)	Specific numerical thresholds for frame accuracy are not provided in the document.

Important Note: The document outlines the acceptance criteria for cNerve but does not explicitly provide the measured numerical performance results of the device against these criteria. It states that the "cNerve performance requirements" are listed but does not follow up with a section detailing the actual tested performance numbers.

2. Sample Size and Data Provenance for the Test Set

Sample Size (Individuals): A total of 44 individuals contributed to the verification dataset.
Sample Size (Sequences/Frames): The test dataset included 124 sequences and 3776 frames.
Relationship between Samples: Each individual contributed up to 2 sequences per view location (often both left and right laterals were scanned).
Demographic Distribution:
- Gender: Male and Female
- Age: 18-82 years
- Ethnicity/Country: USA, Japan, Israel
Subgroups Tested: The algorithm performance was verified via frame accuracy on all demographic subgroups: Gender (M/F), Age (<60 / >=60), BMI (<=25 / >25). It was also tested for all supported nerve block locations and supported probe types.
Data Provenance: The document implies the data was collected from a mix of clinical settings (implied by "USA, Japan, Israel" for ethnicity/country) and clinical scenarios ("all supported nerve block locations and all supported probe types"). The study type (retrospective or prospective) is not explicitly stated, but the process of collecting and annotating an existing dataset suggests a retrospective approach for the dataset creation for validation.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: A single clinical expert annotated the frames from scouting sequences.
Qualifications of Experts: The specific qualifications (e.g., years of experience, specific specialty like "radiologist") of the "single clinical expert" are not detailed in the provided text.

4. Adjudication Method for the Test Set

The ground truth was established by a single clinical expert. Therefore, there was no adjudication method described (e.g., 2+1, 3+1 concensus), as only one expert was involved in marking the ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs without AI assistance. The study focuses solely on the standalone performance measurement of the cNerve algorithm against defined ground truth.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "AI Summary of Testing" section describes the evaluation of the cNerve algorithm's accuracy, focusing on its ability to detect and track nerve bundles independently. The acceptance criteria ("Sequence accuracy requirement - for testing overall cNerve performance") explicitly relate to the algorithm's performance.

7. Type of Ground Truth Used

The ground truth used was expert annotation/consensus (from a single expert). The frames were "annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. Sample Size for the Training Set

The sample size for the training set is not provided in the document. The document explicitly states: "The data used for verification is completely distinct from that used during training process and there is no overlap between the two." However, it does not disclose details about the training data itself.

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

The document does not describe how the ground truth for the training set was established. It only mentions that the test data was distinct from the training data.

Summary

{0}------------------------------------------------

June 21, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Lee Bush Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K220800

Trade/Device Name: Venue Go Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 23, 2022 Received: May 24, 2022

Dear Lee Bush:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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.

For

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. Three water droplet-like shapes surround the circle, adding a decorative element to the design.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Venne Go

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per resoonse, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (361) 485-6746

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text 'K220800' in a clear, sans-serif font. The characters are well-defined and evenly spaced. The 'K' is capitalized, followed by the numbers '220800'. The text is presented against a plain white background.

Image /page/3/Picture/7 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets. The logo is simple and recognizable, and it is associated with a well-known and respected company.

510(k) Premarket Notification Submission

510(k) Summary

Date:	In accordance with 21 CFR 807.92 the following summary of information is provided:June 17, 2022
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Lee BushRegulatory Affairs DirectorGE HealthcareT: (262) 3099429
Secondary Contact Person:	Karin ShimoniRegulatory Affairs ManagerGE Healthcare
Device Trade Name:Common/Usual Name:Classification Names:Product Code:	Venue GoDiagnostic Ultrasound SystemClass IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Primary Predicate Device:Classification Names:Product Code:	K202233 Venue Go, Diagnostic Ultrasound SystemClass IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Reference Device(s):Classification Names:Product Code:	K210438 Versana Premier, Diagnostic Ultrasound SystemClass IIUltrasonic 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
Reference Device(s):Classification Names:Product Code:	K161706 Vivid iq, Diagnostic Ultrasound SystemClass IIUltrasonic 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
Reference Device(s):Classification Names:Product Code:	K203114 LOGIQ P10, Diagnostic Ultrasound SystemClass IIUltrasonic 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
Reference Device(s):Classification Names:Product Code:	K210426 HS40, Diagnostic Ultrasound SystemClass IIUltrasonic 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
Reference Device(s):Classification Names:Product Code:	K202658 Vivid E95, Diagnostic Ultrasound SystemClass IIUltrasonic 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; Diagnostic intravascular catheter, 21 CFR 870.1200, 90-OBJ
Reference Device(s):Classification Names:Product Code:	K182234 Optima XR240amx, Mobile X-ray systemClass IIMobile x-ray system 21 CFR 892.1720 IZL, Solid state x-rayimager 892.1680 MOB

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are four white flourishes around the edge of the circle, one in each quadrant. The logo is simple and recognizable, and it is associated with a well-known and established company.

510(k) Premarket Notification Submission

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and have a vintage look. There are also some white swirls around the letters, which give the logo a dynamic and modern feel.

Device Description: Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time.

The Venue Go utilizes a varietv of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system.

Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices.

The user documentation is available electronically.

The Venue Go is a general purpose diagnostic ultrasound system Intended Use: for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include:

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are three water droplet-like shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity.

	abdominal (GYN and Urology), thoracic/pleural, ophthalmic,Fetal/OB, Small Organ (including breast, testes, thyroid),Vascular/Peripheral vascular, neonatal and adult cephalic,pediatric, musculoskeletal (conventional and superficial), cardiac(adults and pediatric), Transrectal, Transvaginal,Transesophageal, Intraoperative (vascular) and interventionalguidance (includes tissue biopsy, fluid drainage, vascular andnon-vascular access). Modes of operation include: B, M, PWDoppler, CW Doppler, Color Doppler, Color M Doppler, PowerDoppler, Harmonic Imaging, Coded Pulse and Combined modes:B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
	B/CWD, B/Color/CWD.
Technology:	The Venue Go employs the same fundamental scientifictechnology as its predicate and reference devices.
Determination ofSubstantial Equivalence:	Comparison to Predicate DeviceThe Venue Go system is substantially equivalent to the predicatedevice with regards to imaging capabilities, technologicalcharacteristics and safety and effectiveness. All probes used withthe proposed Venue Go system are used unchanged from thecleared predicate. They are made of the same materials and theirshape is unchanged.
	The proposed Venue Go and predicate Venue Go (K202233)have identical clinical indications for use.
	The proposed Venue Go and predicate Venue Go (K202233)have identical imaging modes.
	The following is an overview of the differences between theproposed Venue Go and the predicate Venue Go:The proposed Venue Go and predicate Venue Go (K202233)systems transducers are similar, except for:Additions of M5Sc-RS which was first cleared on Vividiq K161706. This probe is used unchanged from thecleared reference device (K161706). It is made of thesame materials and its shape is unchanged. The clinicalindications of M5Sc-RS are the same on the proposedVenue Go as they are on the reference device Vivid E95K202658 with M5Sc-D probe. The M5Sc-RS probe is thesame as the M5Sc-D except it uses an RS connector

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white curved lines around the letters, resembling water droplets or stylized flourishes. The logo is simple and recognizable, representing the company's brand identity.

510(k) Premarket Notification Submission

instead of a D connector. The transducer body is identical between the two.

New applications are added to the following transducers: .
- o M5Sc-RS transducer: added Ophthalmic application. This application was already cleared with 3Sc-RS in predicate Venue Go (K202233) which is a similar transducer.
- 3Sc-RS, E8C-RS, 6S-RS, 12S-RS: added O Nonvascular access to the Interventional guidance application which was already cleared with these probes on reference device Versana Premier (K210438).

Features/Functionality:

. Scribble: assists the user during system training and teaching by providing a touch-operated pointer and free drawing capabilities.
. Power Doppler Imaging+ (PDI+): is intended for slow blood flows like those found in wrists, ankles, hands, and feet.
Catheter Vessel Ratio: a measurement that supports clinicians in selecting the appropriate sized catheter based on vessel diameter.
. Probe Check: provides an automated probe element check and notifies user of potential probe issue.
. Shoulder Diagram: simplifies documentation and assists the clinician in the follow up for patients with suspected shoulder disorders. Is similar to the Renal Diagram feature previously available on the cleared predicate Venue Go (K202233), except it does not contain an anatomical organ drawing and the question/request that appears to the user is tailored to the shoulder region.
. cNerve: mav help the user to detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material. Is similar to the NerveTrack tool on cleared reference HS40 system by Samsung (K210426). The cNerve tool on proposed Venue Go system is available for adults only.
. Expanding B-lines tool for pediatrics (excluding neonates). This allows Lung sweep and Lung Diagram to pediatrics (excluding neonates) as well. B-lines tool is

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. The circle is surrounded by a white border with four white water droplets equally spaced around the circle. The logo is simple and recognizable, and it is associated with a well-known and respected company.

510(k) Premarket Notification Submission

available on the cleared predicate Venue Go (K202233) for adults only.

Expanding Real-Time Ejection Fraction (EF) to pediatrics ● (excluding neonates). Real-Time EF tool is available on the cleared predicate Venue Go (K202233) for adults only.
Updates to software related to workflow improvements. ●

Accessories:

. Adding compatible OEM biopsy guides (for 3Sc-RS, E8C-RS and M5Sc-RS transducers).
Adding RFID scanner that enables easy login/logout using a badge. This capability is similar to RFID option on reference device Optima XR240amx, K182234.

Summary of Non-Clinical Tests:

The proposed Venue Go 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 comply with applicable medical device safety standards. The Venue Go complies with voluntary standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment -. Part 1: General Requirements for Safety, 2005/ A2:2012
. IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2020
IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
. IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017
. ISO 14971, Application of risk management to medical devices, 2019
NEMA PS 3.1 3.20, Digital Imaging and ● Communications in Medicine (DICOM) Set, 2016

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Three curved lines, resembling water droplets or stylized flames, surround the circle, adding a dynamic element to the design. The overall impression is one of a classic and recognizable corporate symbol.

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 & Validation)
. Safety testing (Verification)

Transducer material and other patient contact materials are biocompatible.

AI Summary of Testing

cNerve:

Summary test statistics and other results including acceptance criteria and information supporting the appropriateness of the characterized performance

Dataset:

Test dataset representative of the Nerve block scouting ● procedures which cNerve supports was assessed for accuracy.
Test dataset included 124 sequences, and 3776 frames.

Appropriateness of the characterized performance:

Success criteria were based on conformance of the cNerve . detections to ground truth annotations of nerve bundles in individual frames. Since the intended use is nerve tracking during scouting rather than nerve segmentation accuracy, success criteria were derived via a preliminary survey. The target of the survey was to identify thresholds for pixel accuracy in frames and for frame accuracy in sequences that are appropriate for the intended use.
cNerve performance requirements.
Sequence accuracy requirement - for testing overall cNerve performance: At least 70% of the sequences are meaningfully detected, and at least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria).

The number of individuals images were collected from:

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are water droplet-like shapes surrounding the circle. The logo is simple and recognizable, and it is associated with a well-known company.

510(k) Premarket Notification Submission

A total of 44 individuals contributed to the verification ● dataset.
The number of samples, if different from above, and the relationship between the two:
. Each individual contributed up to 2 sequences per view location. Often both laterals (left and right) were scanned.
Test dataset included 124 sequences, and 3776 frames. .

Demographic distribution including:

Gender: Male and Female .
Age: 18-82 years
Ethnicity/Country: USA, Japan, Israel ●

Information about clinical subgroups and confounders present in the dataset:

The algorithm performance was verified via frame ● accuracy on all demographic subgroups: Gender (M/F), Age (<60 / >=60), BMI (<=25 / >25).
. Similarly, it was tested for all supported nerve block locations and all supported probe types.

Information about equipment and protocols used to collect images:

Mix of data from across five different probes in the . appropriate nerve mode, and three different Console variants.
Information about how the reference standard was derived from the dataset (i.e. the "truthing" process):
. Ground truth annotations of the verification dataset were obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame.
Description of how independence of test data from training data was ensured:

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white curved lines around the letters, resembling water droplets or stylized flourishes. The logo is simple and recognizable, representing the company's brand identity.

The data used for verification is completely distinct from . that used during training process and there is no overlap between the two.

Summary of Clinical Tests:

The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Venue Go to be as safe, as effective, Conclusion: and performance is substantially equivalent to the 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.