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The Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements. the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

The Caretaker Advanced Hemodynamic Parameters is a firmware upgrade that runs on the Caretaker platform to provide additional hemodynamic measures to the Caretaker Remote Display App And Caretaker Software Library, K181196, and CareTaker Physiological Monitor, (K211588, K163255, K151499). These parameters are not intended to predict or detect cardiovascular mortality or any other condition, disease, and/or patient outcome.

The provided text, primarily an FDA 510(k) Summary, describes the Caretaker Advanced Hemodynamic Parameters device and its substantial equivalence to predicate devices for measuring Cardiac Output/Stroke Volume (CO/SV), Left Ventricular Ejection Time (LVET), and Heart Rate Variability (HRV).

While the document outlines the device's intended use, comparison to predicates, and general claims of "clinically validated evidence" and "equivalent performance," it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets predefined acceptance criteria for accuracy or clinical performance. The provided text focuses on the 510(k) submission and the substantial equivalence claim.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document. I will highlight what can be inferred or found, and explicitly state what information is missing.

Here's an attempt to answer your questions based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state specific numerical acceptance criteria (e.g., mean absolute error, concordance limits) for the advanced hemodynamic parameters (CO/SV, LVET, HRV). It broadly claims "equivalent performance" to the predicate devices.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cardiac Output / Stroke Volume (CO/SV):
  • Sample Size: Not explicitly stated. The text mentions "patient groups" and characteristics like "76% hypertension," "26% diabetes," and "Less than 16%... have a normal BMI

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