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The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: 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 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B, Color and Power Doppler, M modes with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.

This document is a 510(k) Premarket Notification Summary for the GE Healthcare Venue 40 ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested details related to acceptance criteria, study methodologies for AI performance, ground truth, and expert evaluation are not applicable or not provided in this type of submission.

Here's a breakdown of the information that can be extracted or deduced from the document based on your request:

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

The document does not specify quantitative acceptance criteria or report specific device performance metrics in the way one would for an AI/algorithm study (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence through non-clinical tests and conformance to voluntary standards.

The "reported device performance" is implied by the statement: "GE Healthcare considers the Venue 40 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

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 / Not Provided: The document explicitly states: "The subject of this premarket submission, Venue 40, did not require clinical studies to support substantial equivalence." Therefore, no test set, data provenance, or specific clinical study details are 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 / Not Provided: As no clinical studies were performed, there was no ground truth establishment by experts for a test set.

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

• Not Applicable / Not Provided: No test set means no adjudication method.

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 / Not Provided: This is not a study about an AI-assisted device, but rather a general ultrasound system. No MRMC study was performed.

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

• Not Applicable / Not Provided: This is a hardware/software system, not an algorithm being evaluated in isolation.

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

• Not Applicable / Not Provided: No clinical ground truth was established as no clinical studies were deemed necessary. The evaluation relied on non-clinical tests and comparison to predicate devices.

8. The sample size for the training set

• Not Applicable / Not Provided: This submission is not for a machine learning or AI device that would have a "training set."

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

• Not Applicable / Not Provided: No training set or associated ground truth.

Summary of Non-Clinical Tests (from the document):
The document states that the following quality assurance measures were applied to the development of the system:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

These non-clinical tests, along with demonstrating biocompatibility of patient contact materials, form the basis of the safety and effectiveness claims and the determination of substantial equivalence to predicate devices (Venue 40 - K102113, LOGIQ i/e & Vivide e - K102256, Logiq P5 - K060993). The "acceptance criteria" here would be meeting the specifications and performance characteristics of these predicate devices as demonstrated through the non-clinical testing and conformance to voluntary standards.

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The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ablify to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking car, the Venue 40 is used primarily where portability, size and convenience are essential.

The GE Venue 40 Ultrasound device is a diagnostic ultrasound system. As a 510(k) submission, the device does not require clinical studies. The submission makes a claim of substantial equivalence to a predicate device, the GE LOGIQ e Diagnostic Ultrasound (K091374) and the GE Venue 40 Diagnostic Ultrasound (K091164).

1. Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and clinical tests were "None required," there are no specific performance acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy derived from a clinical study.

The acceptance criteria for the device are based on non-clinical testing and comparison to the predicate device. The device is considered to meet acceptance criteria if it is found to comply with applicable medical device safety standards and is substantially equivalent to the predicate device in terms of safety and effectiveness.

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

No clinical test set was used, as clinical tests were not required for this 510(k) submission. Therefore, there is no sample size or data provenance to report in this context.

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

Not applicable, as no clinical test set requiring ground truth establishment by experts was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

No MRMC comparative effectiveness study was done. The submission states "Clinical Tests: None required."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm, and no clinical performance study was conducted.

7. Type of Ground Truth Used

Not applicable, as no clinical study requiring ground truth was performed. The device's "ground truth" for regulatory purposes relies on its demonstrated compliance with safety standards and substantial equivalence to legally marketed predicate devices, rather than a specific clinical ground truth dataset.

8. Sample Size for the Training Set

Not applicable, as this is a medical device (ultrasound system) clearance, not an AI/ML algorithm requiring a training set in the conventional sense.

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

Not applicable, for the same reason as above.

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The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Conventional & Superficial; Intraoperative Vascular: Musculoskeletal (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Venue 40 Compact Ultrasound:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Premarket Notification for the GE Venue 40 Compact Ultrasound, does not explicitly state specific acceptance criteria or quantitative performance metrics for the device itself.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (GE LOGIQ e Diagnostic Ultrasound K072797). This means the acceptance criteria are implicitly tied to the safety and effectiveness profile of the predicate device.

The "reported device performance" is primarily qualitative, asserting that the Venue 40 has "the same overall characteristics, key safety and effectiveness features, physical overall construction, and materials" as the predicate, with "less intended uses and operating modes."

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

• Sample Size for Test Set: Not applicable / None. The document explicitly states "Clinical Tests: None required." The demonstration of substantial equivalence did not involve a clinical test set of patients or data.
• Data Provenance: Not applicable, as no clinical test set was used.

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

• Number of Experts: Not applicable, as no clinical test set was used.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no clinical test set was used.

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

• MRMC Study: No. This device is an ultrasound imaging system, not an AI-powered diagnostic tool requiring a human-in-the-loop study in this context. The submission predates widespread AI integration into medical devices for diagnostic assistance.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No. This device is a diagnostic ultrasound machine, which inherently requires a human operator and interpretation. There is no mention of an "algorithm only" performance evaluation in the context of AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable for a clinical test set, as no such test was conducted. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not explicitly mentioned. Since this is not an AI/machine learning device in the contemporary sense, there isn't a "training set" for an algorithm. The development of the device would have involved engineering, design, and manufacturing processes, but not a data-driven training set for an AI model.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm. The device's "ground truth" for its design and manufacturing is adherence to engineering specifications, safety standards, and performance benchmarks that ensure its functionality and image quality are comparable to the predicate.

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