(104 days)
The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of- care areas in offices, clinical and hospital settings for diagnosis of patients.
The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).
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 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, clinical areas and hospitals, with a focus in critical care and emergency rooms settings. 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 19" high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen can be cleaned with disinfectants. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions. The Venue has a battery that allows scanning continuously for hours without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is optionally 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 Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures and Pinpoint GT option is also available.
The provided text is a 510(k) Premarket Notification Submission for the GE Venue ultrasound system. It outlines the device's technical specifications, intended use, and comparison to predicate devices, but does not contain information about the acceptance criteria and study that proves the device meets those criteria for the type of AI/ML device performance evaluation requested in the prompt.
Specifically, the document states:
- "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence." (Page 16)
- The non-clinical tests performed were primarily related to acoustic output, biocompatibility, cleaning/disinfection, and electrical/mechanical safety (Page 15). These are common tests for ultrasound devices, not performance evaluations of an AI/ML algorithm.
- The "Pinpoint GT Technology" mentioned is described as providing "visual tools for passive magnetic tracking of a needle with respect to ultrasound image data" (Page 3, 13, 14), which sounds like an image guidance system rather than a diagnostic AI/ML algorithm that interprets images for diagnosis.
Therefore, I cannot extract the specific information requested in the prompt regarding acceptance criteria and performance study for an AI/ML diagnostic device from the provided text. The document pertains to a general diagnostic ultrasound system (GE Venue) and its transducers, and appears to be a submission to demonstrate substantial equivalence to existing ultrasound devices, not a new AI/ML diagnostic device requiring specific performance metrics like sensitivity, specificity, or reader studies.
§ 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.