(20 days)
The Aplio XG System is intended to be used for the following types of studies: feta, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and muscoloskeletal (both conventional and superficial.
The Aplio XG Ultrasound System is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of 2 MHz to 12 MHz
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary for an ultrasound imaging system, detailing its features, intended use, and substantial equivalence to a predicate device, along with a list of compatible transducers and their cleared indications.
Therefore, I cannot extract the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- MRMC study details or effect size of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.