(60 days)
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.