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510(k) Data Aggregation
(20 days)
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
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.
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