Search Results

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

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, transvaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac pediatric, peripheral vessel and urology exams.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic, Fetal, Abdominal, Intra-operative (Specify*), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify**), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Thoracic/Pleural (Specify****), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel, Other (Specify***)

*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.

MX7/ MX7T/ Vaus7/ Zeus/ ME7/ Anesus ME7/ Anesus ME7T/ MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, THI, iScape, Biopsy Guidance, eSpacial Navi, Smart 3D mode, Strain Elastography, Contrast imaging (Contrast agent for Liver and LVO) or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

This document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. It does not describe an AI/ML-driven device, therefore, a detailed acceptance criteria table and study results for such a device are not present. However, I can extract the information related to the device's general performance and safety evaluations as presented in the document, which serves as a form of acceptance criteria for a medical device cleared via the 510(k) pathway.

The provided document describes the MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System. This is a general-purpose ultrasound system and not an AI/ML device in the sense of providing automated diagnoses or assisting human readers with AI. The "acceptance criteria" for such a device primarily revolve around safety, effectiveness, and substantial equivalence to legally marketed predicate devices, rather than AI performance metrics like sensitivity, specificity, or AUC.

Here's an analysis of the provided information concerning the device's acceptance criteria and the studies performed:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific quantitative performance metrics as one would expect for an AI/ML device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are met by demonstrating compliance with recognized medical device standards and showing substantial equivalence to predicate devices in terms of technology, intended use, and safety/effectiveness.

The reported "performance" is qualitative, focusing on whether the device meets regulatory and safety standards:

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

The document explicitly states "7. Clinical Tests: Not Applicable." This indicates that no clinical study involving human subjects or real patient data (test sets) was performed for this 510(k) submission to demonstrate performance in a clinical setting. The evaluation relied entirely on non-clinical tests (bench testing, engineering validation, adherence to standards).

Therefore, there is no sample size for a test set, nor specific data provenance (country of origin, retrospective/prospective) related to patient data. The "tests" mentioned are primarily engineering and compliance tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical tests or human reader studies were conducted as part of this submission, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used for performance evaluation that would require adjudication.

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

Not applicable. The device is a diagnostic ultrasound system (hardware and general software features), not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader improvement. The document does not mention any AI capabilities that assist human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a medical device, not a standalone algorithm. The "performance" is inherent to the system's ability to acquire and display ultrasound images and perform basic measurements, which is evaluated through engineering and safety standards.

7. Type of Ground Truth Used:

For the evaluation described, the "ground truth" is established by:

• Compliance with recognized standards: The device's technical specifications and safety features are compared against established industry and regulatory standards (e.g., IEC, ISO).
• Substantial equivalence to predicate devices: The functionality, safety, and performance characteristics are determined to be similar enough to already-cleared devices, implying that if the predicate is safe and effective, so is the new device.
• Engineering validation and bench testing: Physical measurements and tests demonstrating that the device operates within specified parameters and does not pose undue risks (e.g., acoustic output, temperature, electrical safety).

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device's "training" and validation are part of its design, manufacturing, and quality control processes to ensure it meets its specifications and regulatory requirements.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's development and validation relies on engineering principles, scientific understanding of ultrasound physics, and established medical device safety and performance standards.

Ask a specific question about this device