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The Vitalmax 4000 is intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), SpO2 waveform, Pulse (SpO2 and NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate.

The Vitalmax 4100 CN is intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), Sp02 waveform, Pulse (SpO2 and NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate, Nitrous oxide concentration (N2O). The Vitalmax 4100 G and Vitalmax 4100 A include these additional parameters: End-tidal expired Halothane, Enflurane agent-gas concentration (etHAL, etENF. etISO), Inspired Halothane, Enflurane, or Isoflurane agent gas concentration (inHAL. inENF, inISO), Fractional inspired oxygen in gas concentration (Fio2 or %o2).

The Minipack 3000 and Minipack 3100 are intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), SpO2 waveform, Pulse (SpO2 and NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate.

The Minipack 300 and Vitalmax 800 PLUS are intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), SpO2 waveform, Pulse (SpO2 or NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate.

None of the devices are intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).

The Vitalmax 4000 is available in configured and modular form. The Vitalmax 4000 configured monitor is available in various models which offer the options of Co2, thoracic impedance respiration, printer, and invasive pressures. Additional options offered are: Built-in printer with two channels of annotated waveform or text form of vital signs, Thoracic impedance respiration, Invasive pressure waveforms: systolic, diastolic, and mean values (IP, IP2), Second temperature channel and A temp, Analog output.

The Vitalmax 4100 CN, Vitalmax 4100 G, and Vitalmax 4100 A are described with various parameters they measure and monitor. Additional options offered for both models are: Thoracic impedance respiration, Invasive pressure waveform, systolic, diastolic and mean values (IP1, IP2), Second temperature channel and teperature difference [A temp], Built-in strip chart recorder, Sevoflurane, and Desflurane (etSev, inSev, etDes, inDes), Analog Output.

The Minipack 3000 and Minipack 3100 are described with various parameters they measure and monitor. Additional options offered are: Built-in printer with two channels of annotated waveform or text form of vital signs, Thoracic impedance respiration, Invasive pressure waveforms: systolic, diastolic, and mean values (IP1, IP2), Second temperature channel and A temp, Analog output.

The Minipack 300 and Vitalmax 800 PLUS are described with various parameters they measure and monitor. Additional options offered are: Thoracic impedance respiration, Add-on 27 ccolumn thermal printer (Minipack 300 Series), Built-in printer with two channels of annotated waveform (Vitalmax 800 PLUS), Analog output.

The provided text describes an FDA 510(k) clearance letter for various patient monitoring devices (Vitalmax 4000, Vitalmax 4100, Minipack 3000/3100, Minipack 300/Vitalmax 800 PLUS).

This document does not contain information about acceptance criteria or a study proving device performance against such criteria. It is an FDA regulatory clearance letter indicating that the devices are substantially equivalent to previously marketed devices for the stated indications for use.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter explicitly states that the FDA reviewed a "Section 510(k) notification of intent to market the device" and "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This process generally involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, performance testing, and comparison, rather than extensive clinical studies with specific performance metrics and expert-adjudicated ground truth as might be seen for novel or higher-risk devices.

The listed parameters (ECG, NIBP, SpO2, Temperature, EtCO2, Respiration Rate, etc.) are the intended measurements and monitoring capabilities of the devices, not performance metrics or acceptance criteria derived from a specific study outlined in this document.

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