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The Venue Go is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners 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. Users may also include medical students working under the supervision or authority of a physician during their education / training. 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, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), 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.

Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified and trained 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 with full functionality and scanning.

The Venue Go utilizes a variety 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 built-in 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 provided FDA 510(k) summary for the GE Venue Go ultrasound system does not include acceptance criteria for artificial intelligence (AI) performance or the study details to prove the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venue Go K220800) and other reference devices, based on:

• Identical fundamental scientific technology.
• Similar imaging capabilities, technological characteristics, safety, and effectiveness.
• Minor updates to the Indications for Use statement for clarity regarding operator qualifications.
• Addition of new transducers already cleared on other GE devices.
• New features/functionality such as Auto Volume Flow (AVF), Bladder Volume Tool, expanded MSK diagrams, Venue Coach, electronic software delivery, expanded Auto Inferior Vena Cava (IVC), Auto B-Lines, Real-Time ejection fraction (RT-EF), cNerve for Vscan Air CL and SL probes (which are already cleared with these AI features on predicate Vscan Air K231301 and reference LOGIQ E10s/LOGIQ Fortis K231989), and AppAPI functionality.
• Conformity to recognized performance standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.
• Quality assurance measures like risk analysis, requirements/design reviews, and various levels of testing.

Specifically, the document states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This indicates that any evaluation of "AI performance" as typically understood (e.g., using a test set with ground truth, performance metrics, and acceptance criteria) was not part of this 510(k) submission.

The AI-related features mentioned (Auto IVC, Auto B-Lines, RT-EF, cNerve) are noted as being "expanded" or already "cleared" on predicate/reference devices (K231301 Vscan Air, K231989 LOGIQ E10s/LOGIQ Fortis). This implies their performance was likely evaluated as part of those previous 510(k) submissions, and the current submission is leveraging that prior clearance for their inclusion in the Venue Go system when used with the particular probes.

Therefore, since this 510(k) does not present new AI performance study data for the Venue Go, I cannot extract the requested information. The document focuses on demonstrating that the Venue Go, with its included features, is substantially equivalent to existing cleared devices, rather than proving novel AI algorithm performance.

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The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners 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. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: 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 interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B. M. PW Doppler, CW Doppler, Color M Doppler, Color M 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.

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals.

The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

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.

Barcode reader and RFID scanner are available as additional input devices.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet.

System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

The provided document is a 510(k) Summary for a diagnostic ultrasound system (Venue). It does not contain information about acceptance criteria and a study that proves the device meets those criteria for software performance.

The document states:

• "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence." (Page 10)
• The comparison is primarily focused on hardware, transducers, and general features, and states that the Venue system is substantially equivalent to a predicate device regarding "imaging capabilities, technological characteristics and safety and effectiveness." (Page 6)

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies because this document does not present such a study. The submission focuses on demonstrating substantial equivalence to a predicate device, which often relies on non-clinical tests and comparisons rather than new clinical performance studies.

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TeleScan™ is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan™ provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis.

TeleScan™ is used by appropriately trained healthcare professionals. including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan™ may provide information to be used for screening and diagnostic procedures. TeleScar™ allows remote qualified radiologists and clinicians to provide a diagnosis remotely.

TeleScan™ is used by trained medical professionals, including radiologists, sonographers, technologists, and clinicians, and may provide information to be used for screening and diagnostic procedures. These individuals are referred to as Healthcare Workers (HCWs) for the purposes of this submission.

Similar to tele-radiology solutions, TeleScan™ allows remote, qualified radiologists and clinicians to provide a diagnosis remotely. TeleScan™ receives ultrasound DICOM images transmitted from leqally marketed ultrasound machines and displays images. This includes videos (cineloops), diagnostics tools for annotation, and a simplified workflow for report creation. TeleScan™ is compatible with ultrasound images acquired by appropriately trained healthcare professionals in medical facilities.

The software provides the Sonographer tools to display patient measurements and observations. The application also calculates gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated due date and estimated fetal weight is calculated.

The report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports such as physicians, specialists, and nurse practitioners. For the purposes of this submission, these individuals are referred to as "Physicians".

TeleScan™ is offered as software as a service (SaaS) and complies with digital health and data related laws, including but not limited to HIPAA.

Here's a summary of the acceptance criteria and study information for the TeleScan™ device based on the provided document:

This device (TeleScan™) is a medical image management and processing system for ultrasound images. The 510(k) submission states that no clinical studies were performed to support substantial equivalence. The performance testing conducted was non-clinical. Therefore, there are no specific performance criteria or a study that directly proves the device meets those criteria in a clinical setting as would be
expected for AI/ML devices that perform diagnostic, screening or prognostic functions.

The document indicates "The performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate (Unifi Workspace, K190694) for specific application features."

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) from clinical studies are provided, the "acceptance criteria" here are inferred from the substantial equivalence claim based on functional and technical comparisons to predicate devices. The device's "performance" is stated as being equivalent in these non-clinical aspects.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described is "nonclinical testing," "bench testing, including functional testing and usability testing." No details on the sample size or provenance of images/data used for this non-clinical testing are provided.

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

Not applicable. As no clinical test set requiring expert ground truth was performed, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set was used, no adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "No clinical studies have been performed to support substantial equivalence." TeleScan™ is described as a medical image management and processing system with various tools, not an AI/ML diagnostic algorithm that directly assists human readers in such a way that would be assessed through an MRMC study comparing performance with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. The device is a "software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data," and "provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis." It is not a standalone diagnostic algorithm that operates without human interaction or interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Given the nature of the non-clinical testing and the absence of clinical studies, no "ground truth" for diagnostic accuracy (e.g., from pathology or expert consensus on clinical cases) was established or used. The "ground truth" for functional testing would typically involve verifying software outputs against expected calculations or displays.

8. The sample size for the training set

Not applicable. The document describes TeleScan™ as a medical image management and processing system with tools, not an AI/ML model that would require a "training set" in the conventional machine learning sense.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/ML model.

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