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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.

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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.

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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.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

When PinpointTM GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

This document is a 510(k) premarket notification for the GE Healthcare LOGIQ P9 and LOGIQ P7 ultrasonic imaging systems. It asserts substantial equivalence to predicate devices, meaning that clinical studies were not required to demonstrate safety or effectiveness for the new device. Therefore, no acceptance criteria in terms of clinical performance metrics, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies are applicable or reported here.

The document focuses on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) premarket notification establishing substantial equivalence based on non-clinical testing and comparison to predicate devices, there are no specific performance-based acceptance criteria or reported device performance in the format of a quantitative clinical study outcome table. The "performance" is implicitly deemed equivalent to the predicate devices through a qualitative comparison.

The acceptance criteria here would be compliance with recognized medical device safety standards and demonstration of technological equivalence to already cleared devices.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document states: "The subject of this premarket submission, LOGIQ P9 and LOGIQ P7, did not require clinical studies to support substantial equivalence." Therefore, no test set data of patients or clinical images were collected, and no provenance information is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical studies were performed, no ground truth needed to be established by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

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

Not applicable. No clinical studies were carried out, and the device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

Not applicable. The device is a diagnostic ultrasound system, not a standalone algorithm.

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

Not applicable. No clinical ground truth was established for a test set. The ground truth for proving substantial equivalence was based on regulatory compliance and comparison to existing cleared devices.

8. The sample size for the training set

Not applicable. No machine learning algorithm or training set is mentioned in the context of this 510(k) submission for demonstrating substantial equivalence. The "training" of the device refers to its engineering and verification processes in compliance with standards, not a machine learning training set.

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

Not applicable. No machine learning algorithm or training set with associated ground truth is referenced.

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Vscan Extend is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage.

With the phased array transducer on the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.

With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediatrics.

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Vscan Extend is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a 5 inch touch screen display and a permanently attached probe. The probe is available in one of two configurations: a sector probe with phased array transducer or both phased and linear array transducers in the single probe (dual probe). It has digital acquisition, processing and display capabilities. The device specific battery can be charged either in the system or independently. The system also may include an AC/DC adapter with cable, case, Micro SD card, USB cable, or other accessories.

The system is capable of transferring images wirelessly to a DICOM server or Windows share. Data can also be exported to the user's computer by using the USB export option and a standard USB/micro USB cable. Capabilities also include access to GE Marketplace. which shall allow the user to download software applications to the device.

The provided document is a 510(k) premarket notification for the GE Vscan Extend ultrasound system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance efficacy studies with acceptance criteria for an AI/algorithm-driven device in the manner requested.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, are not available in this document.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, or specificity. Instead, it demonstrates "substantial equivalence" based on technological characteristics and safety. The reported performance relates to the device's functional capabilities and compliance with safety standards, rather than clinical efficacy metrics against specific acceptance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document states: "The subject of this premarket submission, Vscan Extend, did not require clinical studies to support substantial equivalence." Therefore, there is no test set in the context of clinical performance evaluation described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies were required or performed for this premarket submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies were required or performed for this premarket submission.

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

Not applicable. This is a submission for an ultrasound imaging system, not an AI-assisted diagnostic device. The document explicitly states "did not require clinical studies."

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

Not applicable. This is not an AI/algorithm-only device. It is a diagnostic ultrasound system.

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

Not applicable, as no clinical studies were required or performed for this premarket submission.

8. The sample size for the training set

Not applicable, as no AI model training is described for this device in the context of this submission.

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

Not applicable, as no AI model training is described.

Summary of Non-Clinical Tests and Standards Met (from the document):

The device underwent non-clinical tests to ensure safety and functionality. These include:

• Acoustic Output: Evaluated for compliance.
• Biocompatibility: Evaluated, transducer materials are biocompatible.
• Cleaning and Disinfection: Evaluated.
• Thermal, Electrical, Electromagnetic, and Mechanical Safety: Evaluated.

The device conforms to the following voluntary standards:

• AAMI/ANSI ES60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance, 2005
• IEC60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
• IEC60601-2-37: Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
• NEMA UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
• ISO10993-1: Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009
• NEMA UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004
• ISO14971: Application of risk management to medical devices: Second edition, 2007
• NEMA PS 3.1-3.20 (2011): Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

Quality assurance measures applied during development:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Verification of Privacy & Security Design

Conclusion of the device's substantial equivalence:
GE Healthcare considers the Vscan Extend to be as safe, as effective, and performance is substantially equivalent to the predicate device(s) based on intended use, imaging capabilities, technological characteristics, and safety and effectiveness. The document highlights that the Vscan Extend employs the same fundamental scientific technology as its predicate devices, shares the same clinical intended use (with the addition of adult cephalic cleared on a predicate), imaging modes, materials, acoustic power levels (below FDA limits), and capabilities for measurements, digital image capture, and review. It also specifies similar connectivity features (WiFi, DICOM) and data privacy features (internal storage encryption) to reference predicate devices.

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