Search Results

The Versana Balance is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, 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, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/ Color/PWD, B/Power/PWD, B Flow/B Flow Color.

Versana Balance is intended to be used in a hospital or medical clinic.

The Versana Balance is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.

The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.

The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device.

The variety of transducers include convex, linear, sector, and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.

Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) summary from the FDA for a diagnostic ultrasound system (Versana Balance). While it details the device, its intended use, and comparisons to predicate devices, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for AI features.

The document states: "The subject of this premarket submission, Versana Balance, did not require clinical studies to support substantial equivalence." This means that the device's clearance was based on its similarity to previously cleared devices, rather than a new clinical study demonstrating specific performance metrics for AI in humans.

The document mentions an "Artificial Intelligence (AI) feature that identifies key anatomies/organs", namely "Whizz Label". It also states that "Whizz Label was first cleared with Versana Premier (K210438)". This implies that any performance data or acceptance criteria for this AI feature would have been part of the K210438 submission, not K220446.

Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions related to the acceptance criteria and the study proving the device meets those criteria for the AI features requested. This document focuses on the substantial equivalence of the overall ultrasound system to predicate devices, rather than detailed performance metrics of its AI components.

Ask a specific question about this device

The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), VascularPeripheral 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, 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 Fit 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 Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. 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 Fit utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability. supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.

The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

Venue Fit is capable of wired or wireless internet connection and a barcode reader is available to be used as an input device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory available for the customer is a roller bag.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification submission for a medical device (Venue Fit ultrasound system).

It primarily focuses on:

• Regulatory information: FDA letter, indications for use, and a 510(k) summary.
• Device description: Explaining the Venue Fit's features, intended use, and technical specifications.
• Comparison to predicate devices: Highlighting similarities and differences with previously cleared GE ultrasound systems.
• Non-clinical tests: Listing the safety and performance standards the device complies with (e.g., acoustic output, biocompatibility, electrical safety).
• A statement explicitly saying: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence."

Therefore, there is no information regarding:

• Acceptance criteria for AI/algorithm performance.
• Results of a study proving the device meets acceptance criteria (as no clinical studies were required).
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for training was established.

This document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, rather than a clinical study involving AI performance metrics.

Ask a specific question about this device

The Venue Go is a general purpose diagnostic ultrasound system 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: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), VascularPeripheral 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, 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.

The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.

The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.

The provided text describes the GE Medical Systems Ultrasound and Primary Care Diagnostics' Venue Go device and its 510(k) premarket notification. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the document details the device's technical specifications, intended use, comparison to predicate devices, and compliance with non-clinical safety standards (acoustic output, biocompatibility, electrical safety, etc.). The "Summary of Non-Clinical Tests" section outlines various standards the device complies with, but these are safety and engineering standards, not performance criteria for a diagnostic algorithm.

Specifically, the "Summary of Clinical Tests" section explicitly states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This means that no clinical performance study was conducted to establish diagnostic accuracy metrics for the device itself. The substantial equivalence argument is based on its similarity to existing, legally marketed ultrasound systems.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as it is not present in the provided text.

If you have a document that describes the diagnostic performance claims and supporting studies for the Venue Go or a similar medical device, please provide that text, and I will be able to answer your questions.

Ask a specific question about this device

The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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), VascularPeripheral 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, 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.

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 proposed Venue has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support 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.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not contain specific acceptance criteria or quantitative performance metrics for the device itself. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing:

• Clinical Indications for Use: Similar, with some additions cleared on reference devices.
• Technological Characteristics: Same fundamental scientific technology.
• Safety and Effectiveness: Assessed through non-clinical tests.
• Imaging Modes and Transducers: Largely identical or similar, with additions cleared on reference devices.
• Features/Functionality: Modifications or additions that are similar to features already cleared on predicate or reference devices.

Therefore, a table of acceptance criteria and reported device performance, as typically understood for AI/ML device performance, cannot be constructed from this document. The "performance" being demonstrated here is the device's adherence to safety standards and its functional equivalence to existing cleared devices.

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

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Therefore, there was no test set as part of a clinical study for this 510(k) submission, and consequently, no sample size or data provenance information.

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

As no clinical study was required and no test set was used, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no clinical study was required and no test set was used, this information is not applicable and not provided in the document.

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

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Therefore, no MRMC study was performed, and this information is not applicable and not provided in the document. The device descriptions focus on general ultrasound functionalities without specific mention of AI-assisted diagnostic features that would warrant such a study. While some "automated tools" are mentioned, their performance is established through similarity to pre-cleared features, not through comparative effectiveness studies in this submission.

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

The document states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Therefore, no standalone performance study was done for this submission, and this information is not applicable and not provided in the document.

7. The Type of Ground Truth Used

As no clinical study was required and no test set was used, this information is not applicable and not provided in the document. The substantial equivalence argument relies on comparison to predicate and reference devices, not on direct ground truth validation in a clinical setting for this specific submission.

8. The Sample Size for the Training Set

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Since no clinical studies were performed, and the submission does not describe the development or training of new AI/ML algorithms requiring a training set, this information is not applicable and not provided in the document. The "automated tools" mentioned are described as modifications or similar to features already cleared on other devices.

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

As no training set was used for a clinical study in this submission, this information is not applicable and not provided in the document.

Ask a specific question about this device