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The Venue 50 is intended for ultrasound masurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiae (adult & pediatic); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal); Thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

When Pinpoint 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 Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console (tablet sized) with the ability to dock it with a Docking station or mobile Docking cart. The portable design easily fits into tight spaces. High-resolution imaging, transducer options and wide range of applications help physicians care for a broad spectrum of patients. The singlesurface screen can be disinfected and cleaned with medical grade disinfectants. Flexible data management and connectivity options, with optional DICOM, help speed image storage and archiving for physicians at the Point of Care and patient bedside.

The requested information is not available in the provided text. The document is a 510(k) premarket notification for the GE Venue 50 ultrasound system, which states that no clinical studies were required or performed to support substantial equivalence for this device. Therefore, there is no information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venue 50 K133431) based on technological characteristics and safety standards. Details include:

• Device Description: A compact and portable ultrasound system with a hand-carried console, dockable with a docking station or mobile cart.
• Intended Use: Ultrasound imaging, measurement, and analysis for various clinical applications (Ophthalmic, Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculoskeletal Conventional & Superficial, Transvaginal, Intraoperative, Thoracic/Pleural for motion and fluid detection, and imaging guidance of interventional procedures). It also includes Pinpoint GT Technology for needle tracking.
• Technology: Employs the same fundamental scientific technology as its predicate devices.
• Comparison to Predicates: The Venue 50 is considered substantially equivalent to predicate devices in intended use, imaging capabilities, technological characteristics, safety, and effectiveness.
• Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection, as well as thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards and voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, DICOM).
• Quality Assurance: Risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing.

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The Venue 50 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

The Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console approximately 282mm in height. 274mm in width and 56mm in depth. The console can be docked with a Docking station or mobile Docking cart. It has a 12.1" LCD display with finger-touch user interface. The single-surface screen can be sanitized and cleaned with medical grade disinfectants. Several connectivity options are available including DICOM.

The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Venue 50 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria for device performance based on a study of the device itself. Instead, it outlines the device's intended use, technological similarity to predicate devices, and compliance with various non-clinical safety and performance standards.

Therefore, many of the requested items (e.g., acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) cannot be extracted or are not applicable from this document, as it explicitly states:

"The subject of this premarket submission, Venue 50, did not require clinical studies to support substantial equivalence." (Page 4)

This implies that the device's safety and effectiveness were demonstrated through a comparison to already cleared predicate devices and adherence to recognized standards, rather than through new clinical performance studies with specific acceptance criteria that would involve human readers, ground truth consensus, or effect sizes of AI assistance.

However, I can provide the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

As the document explicitly states no clinical studies were required to support substantial equivalence, there are no specific performance acceptance criteria or reported device performance metrics in terms of clinical accuracy, sensitivity, or specificity. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence, meaning the device performs similarly to or no worse than the predicate devices in its intended use.

The non-clinical "acceptance criteria" are related to compliance with voluntary standards:

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set defined to assess performance against specific acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts.

4. Adjudication method 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. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool, and no MRMC study was performed.

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: Not applicable. No clinical test set with ground truth used.

8. The sample size for the training set: Not applicable. No machine learning algorithm requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable. No machine learning algorithm and thus no training set ground truth established.

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