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The NICaS 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

The NICaS 2001 is a noninvasive cardio-respiratory monitor which unlizes bioimpedance measurements from the blood circulatory system to calculate hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index and total peripheral resistance) and ventilatory parameters (including respiratory rate). The NCaS 2001 uses 4 electrodes that pick up the signals which are amplified inside the patient module. After signal amplification and filtration, the analysis is done by a powerful microprocessor. The microprocessor-driven software includes unique algorithms that reject artifacts and perform all required calculations for stroke volume (SV) and other derived parameters. The results are displayed on a PC screen. The software allows data storage, recall/review and printout. The electrodes are nondisposable (standard electrode by Nicolet) "strap" style attached to cable leads. These electrodes consist of two 55 cm electrode strips for the leg and two 25 cm electrode strips for the arm. The electrodes are attached to the two identified input connectors of the patient module. The patient module also connects with the computer.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested quantitative information. It primarily focuses on comparing the NICaS 2001 device with a predicate device and outlining its intended use and safety standards.

However, based on the limited information provided, here's what can be extracted and inferred:

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

The document doesn't explicitly state quantitative acceptance criteria. Instead, it relies on a comparison to "standard invasive technique of thermodilution" for cardiac output and another physiological monitor for respiratory rate. Therefore, the "reported device performance" is essentially the correlation observed in these studies.

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

• Cardiac Output Study (Dr. H. Miller):
  • Sample Size: Not specified.
  • Data Provenance: Ichilov Hospital, Israel. The study type (retrospective/prospective) is not specified.
• Respiratory Rate Study (Dr. Michael Luchansky):
  • Sample Size: Not specified.
  • Data Provenance: Tel Aviv Medical Center. The study type (retrospective/prospective) is not specified.

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)

Not applicable. The ground truth was established by objective measurements:

• Cardiac Output: Standard invasive thermodilution technique (a measurement, not expert opinion).
• Respiratory Rate: Horizon 2000 Physiological Monitor (a device, not expert opinion).

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

Not applicable. No expert adjudication method was mentioned or would be relevant given the objective nature of the ground truth measurements (thermodilution and another device).

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

Not applicable. This device is a standalone physiological monitor, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study or AI assistance effect size is not relevant.

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

Yes, the studies described are standalone performance evaluations of the NICaS 2001 device itself, comparing its measurements to established methods. There is no indication of a human-in-the-loop component in these performance evaluations.

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

• Cardiac Output: Objective measurement from a "standard invasive technique of thermodilution."
• Respiratory Rate: Objective measurement from a "Horizon 2000 Physiological Monitor."

8. The sample size for the training set

The document does not mention any training set or machine learning aspects for this device. The "unique algorithms" for artifact rejection and calculations are inherent to its design, not explicitly trained on a separate dataset in the sense of modern AI.

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

Not applicable, as no training set is described. The device's "unique algorithms" are presumably based on established bioimpedance principles and modifications of the Kubicek algorithm.

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