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The patient monitor is intended to monitor the basic physiological parameters of the patient under the direct supervision of a licensed healthcare practitioner. It can be used for all patients from Adult to Neonatal. The monitor is designed as a bedside or portable monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities.

The UT 4000F is not intended for use as an apnea monitor. The UT 4000F is not intended for use during MRI or CT scans.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and carbon dioxide.

The UT 4000F Patient Monitor is also intended to provide physiological data over a network to clinical information systems and allow the user to access hospital data at the point of care.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device (Goldway UT 4000F Patient Monitor), which determines substantial equivalence to a predicate device. It indicates that the device can be marketed, but does not detail performance studies or explicit acceptance criteria.

The supplied text primarily focuses on:

• The FDA's 510(k) clearance for the Goldway UT 4000F Patient Monitor.
• The regulatory classification (Class II).
• General controls and other regulations the manufacturer must comply with.
• The stated Indications for Use for the device.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a performance study, because this data is not present in the given document.

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