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The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.

The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features. The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.

I am sorry, but the provided text only details a 510(k) summary for a medical device called "AS/3™ M-ESTPR," an electrocardiographic device. It describes its function as part of a modular anesthesia monitoring system and lists the physiological parameters it measures (ECG, SpO2, invasive pressure, temperature, and impedance respiration).

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance for specific clinical outcomes.
• Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC, standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.

AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. AS/3 Light Monitor will be available in two following configurations: LM which measures ECG, SpO2, 1 temperature and NIBP and LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.

The provided text is a 510(k) summary for the Datex AS/3 Light Monitor, a patient vital signs monitor. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Datex AS/3 Compact Monitor with ESTP and NIBP modules).

However, the document does not contain information related to acceptance criteria, detailed study results proving device performance against acceptance criteria, or specifics about a study design involving experts, ground truth, or statistical analysis (like MRMC studies) typically associated with AI/ML device evaluations.

This 510(k) summary is for a traditional medical device (a vital signs monitor), not an AI/ML powered device. Therefore, the requested information elements, particularly those related to "AI improvement," "ground truth," "training set," and "expert consensus/adjudication," are not applicable and are not present in the provided text.

The document states that "The specifications of the monitors were compared and AS/3TM Light Monitor was tested against the specifications." This indicates that performance was evaluated against a set of predefined specifications, but the specifics of these specifications and the detailed test results are not included in this summary. The summary only concludes that the results "showed that AS/3TM Light Monitor is substantially equivalent with AS/3TM Compact Monitor."

If this were an AI/ML device submission, the requested information would be crucial. As it stands, the provided text does not allow for a complete answer to your detailed questions.

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