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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<25" across "all cohorts." This implies data from multiple subjects (cohorts), but the total number is not provided.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

• Left Ventricular Ejection Time (LVET):

  • Sample Size: A demographic table is provided for 47 subjects (indicated by 27 (57.5%) for Male Sex, and 40 (85.1%) for Hypertension, etc., summing up to 47 for some percentages).
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study appears to be clinical ("Primary indications for cardiac catheterization procedures...").

• Heart Rate Variability (HRV):

  • Sample Size: 60 subjects (34 male / 26 female).
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The description of interventions ("hand in ice-bath immersions, ice bag on forehead, light valsalva maneuvers") suggests a prospective controlled study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. For hemodynamic parameters, ground truth is typically established by established reference methods, not human adjudication of images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This type of study (MRMC) is typically associated with AI in image interpretation where human readers (e.g., radiologists) are assisted by AI. For a device measuring physiological parameters, an MRMC study is not applicable or described. The device directly measures parameters; it does not assist human interpretation of complex medical cases in a comparative effectiveness study context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as providing measurements directly. The language "Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV)..." and "The Caretaker Physiological Monitor System is substantially equivalent to the NexFin HD in terms of providing the hemodynamic parameters" implies that the algorithm generates the parameters independently. Therefore, the performance described would inherently be standalone algorithm performance compared to a reference standard (e.g., thermodilution for CO/SV). However, a specific "standalone study" with detailed results/metrics is not presented.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cardiac Output / Stroke Volume (CO/SV): "calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output"
• Left Ventricular Ejection Time (LVET): "obtained from central aortic BP tracings by measuring the time interval between the initiating point of upstroke of the aortic pressure wave form and the dichrotic notch according to established guidelines." This implies a reference standard derived from invasive pressure measurements.
• Heart Rate Variability (HRV): The document states "measures derived from a peripheral mechanical arterial pulse sensor" and comparison to the predicate ANSWatch, but doesn't explicitly state the ground truth for HRV itself beyond the predicate device. It implies the predicate served as the reference for equivalence.

8. The sample size for the training set

The document does not provide any information regarding the training set size for the device's algorithms.

9. How the ground truth for the training set was established

The document does not provide any information regarding how the ground truth for the training set was established.

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