(24 days)
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Fetal - OB
Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel
The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.
The provided document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and study designs.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of an AI or algorithm. This notification is for an ultrasound imaging system, which produces images for human interpretation, not an AI-powered diagnostic device that would have specific performance metrics like sensitivity, specificity, or reader improvement.
Here's why the requested information cannot be extracted from this document:
- No AI/Algorithm: The document describes a general-purpose ultrasound system. There is no mention of any integrated AI, machine learning algorithm, or software that performs automated diagnoses or assists in interpretation beyond standard imaging functionalities (e.g., SonoHD3 Imaging for speckle reduction, which is a signal processing technique, not an AI for diagnosis).
- Substantial Equivalence: The core of a 510(k) submission is to show that the new device is "substantially equivalent" to a legally marketed device (predicate) in terms of intended use, technological characteristics, and safety/effectiveness. This typically involves non-clinical tests (electrical safety, EMC, biocompatibility, acoustic output, and adherence to standards) rather than clinical performance studies for diagnostic accuracy against predefined acceptance criteria for an AI.
- No Clinical Performance Data on "AI": The document explicitly states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This further confirms that no clinical performance data (like sensitivity, specificity, or MRMC studies) related to an AI or algorithm's diagnostic performance was generated or presented in this submission.
- "Acceptance Criteria" for a PURE Imaging Device: For an ultrasound imaging system, acceptance criteria would revolve around image quality (resolution, contrast, penetration, etc.), safety (acoustic output, electrical safety), usability, and reliability, rather than diagnostic accuracy metrics of an AI. These are typically assessed through engineering tests and comparison to the predicate's performance specifications, not through studies with expert ground truth establishment for a test set of diagnoses.
In summary, as this document pertains to a general diagnostic ultrasound system and not an AI/ML-powered diagnostic device, the requested information (AI acceptance criteria, test set, experts, MRMC studies, etc.) is not applicable and therefore not present.
§ 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.