(34 days)
The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel
The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readly lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.
The provided text appears to be a 510(k) summary for a medical device (ultrasound system) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document mainly focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety standards.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance study results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means no clinical performance studies were conducted or reported for this submission to demonstrate device performance against specific acceptance criteria. The approval was based on demonstrating equivalence to an existing marketed device through non-clinical tests (electrical safety, thermal, mechanical, EMC, biocompatibility, acoustic output, etc.) and shared technological characteristics.
§ 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.