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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal (new indication)

Portascan Bladder Scanner; Portascan Probe (3.5 MHz/5.0 MHz Transabdominal & Bladder)

This looks like an FDA 510(k) clearance letter for the Portascan Bladder Scanner, not a study document. It establishes substantial equivalence to a predicate device and gives permission to market the device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't describe the performance of the device, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The provided text only contains:

• Regulatory Information: Device name, regulation numbers, product codes, and the FDA's determination of substantial equivalence.
• Intended Use: The clinical applications for which the device is cleared, specifically for "Abdominal" imaging (indicated by 'N' for new indication in the first table of the "Diagnostic Ultrasound Indications for Use Form" for the "Portascan System"). The second table identifies the "Portascan Probe" manufactured by Pie Medical with a previous 510(k) number as the system.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report from the 510(k) submission.

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