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The LOGIQ α200 diagnostic ultrasound system is intended for use in diagnostic ultrasound imaging using B, M, and B/M combination modes in the following areas:

• Fetal
• Abdominal
• Intraoperative
• Pediatric
• Small organs including breast, neck, chest, male and female reproductive organs, limbs, and extremities
• Adult Cephalic
• Neonatal cephalic
• Adult cardiac
• Pediatric cardiac
• Trans-vaginal
• Trans-rectal

The LOGIQ α200 diagnostic ultrasound system consists of a mobile console approximately 40 cm wide, 60 cm deep and 125 cm high, weighing approximately 70 kg. The user interface consists of a keyboard and monochrome video monitor. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes. Optional image storage or hard-copy devices are integrated into the design.

I am sorry, but based on the provided 510(k) summary for the GE LOGIQ α200 Diagnostic Ultrasound System, there is no information available regarding acceptance criteria, device performance studies, or clinical validation data as you've requested.

The document primarily focuses on:

• Identification of the submitter and product.
• A general description of the device.
• Stated Indications for Use.
• Comparison to a predicate device (GE Medical Systems RT2800).
• A summary of studies related to acoustic output, biocompatibility, and safety (thermal, electrical, mechanical) demonstrating conformity with medical device safety standards.
• A conclusion of substantial equivalence based on safety and effectiveness to predicate devices.

This type of 510(k) summary, especially from 1996, typically focuses on demonstrating substantial equivalence to a previously cleared device by showing similar technological characteristics and performance for safety aspects. It does not generally include detailed clinical performance studies, such as those that would establish specific acceptance criteria for diagnostic accuracy (sensitivity, specificity, AUC, etc.) or report detailed device performance metrics in a clinical context.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

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