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Palm Bladder Scanner - PBSV5.1 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.

The provided document is a 510(k) premarket notification for the Palm Bladder Scanner - PBSV5.1. It asserts substantial equivalence to a predicate device (PBSV4.1) rather than proving the device meets a set of acceptance criteria through a clinical study involving AI assistance.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria for an AI/ML-driven device. Specifically:

• It states clearly under "7.1 Clinical Tests" that "Clinical testing was not performed for the subject device as part of the submission."
• The comparison focuses on hardware/software changes from a previous version of the same device, not a performance study against a defined ground truth with human readers or standalone AI performance metrics.
• The device is a bladder scanner that calculates bladder volume non-invasively, not explicitly an AI/ML system requiring extensive comparative effectiveness studies with human readers or complex ground truth establishment methods typically associated with AI.

The document focuses on non-clinical tests to demonstrate that the changes (housing, digital circuit, software UI optimization, battery) do not raise new questions of safety and effectiveness and that the device meets design specifications and relevant electrical safety, performance, and software standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, IEC 62304, ISO13485, IEC62133).

Therefore, I cannot provide the requested table and study details because the provided text does not describe such a study for this device.

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