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The indications for use for the Passport 5L-CE Monitor include the monitoring of the following human physiological vital signs:

• Blood Oxygenation (SpO2) measurement/waveform
• ECG waveform derived from 3 or 5 Lead measurements
• Respiration rate/waveform derived from ECG or CO2
• Temperature measurement via YSI 400/700 series probes
• Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
• Non Invasive Blood Pressure (NIBP) measurement
• CO2, Inspired and end tidal mainstream/waveform
• Heart Rate derived from selected source ((SpO2, ECG, IBP, NIBP)

Passport 5L-CE Vital Signs Monitor

I apologize, but the provided text from the FDA 510(k) letter for the "Passport 5L-CE Vital Signs Monitor" does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance.

The letter primarily focuses on:

• Substantial Equivalence Determination: The FDA's finding that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Classification: Class II.
• Permitting Marketing: Allowing the device to be marketed.
• General Controls: Highlighting requirements for registration, listing, good manufacturing practice, labeling, etc.
• Indications for Use: Listing the physiological vital signs the monitor is intended to measure (SpO2, ECG, Respiration rate, Temperature, Invasive Blood Pressure, Non-Invasive Blood Pressure, CO2, Heart Rate).

It does not include:

1. A table of acceptance criteria or reported device performance metrics. This type of detail would typically be found in the 510(k) submission itself, which is not provided here.
2. Details of any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) conducted to demonstrate performance. The letter simply states the device is substantially equivalent, implying that its performance is comparable to the predicate device, but doesn't elaborate on the studies that supported this.

Therefore, I cannot provide a comprehensive answer to your request based solely on the provided text. To answer your questions, additional information from the actual 510(k) submission (K974178) would be required.

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