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The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

The NICaS (non-invasive cardiac system) is a CD-ROM shaped device which replaces the actual CD-Rom of a laptop computer. It is used for noninvasive cardiac diagnostic purposes.

The NICaS (non-invasive cardiac system) SLIM 2004 is an impedance device which is unique in its use of a laptop computer as part of a technology for non-invasively measuring the cardiac output and its derivatives. The NICaS is also unique in that it is the only method of impedance cardiography (ICG) which utilizes only two pairs of impedance electrodes, placed on two limbs, preferably one pair on the wrist, and the other on the contra-lateral ankle. This type of electrical surveillance is called regional ICG, or RIC.

The NICaS is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ.

The principle of this technology is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed OR, and the baseline body resistance is R (0).

The analog resistance signals are received by the device, where they are amplified and filtered. These signals are then transmitted to a microprocessor. where they are digitized and analyzed via mathematical algorithms.

Here's a breakdown of the acceptance criteria and study information for the NICaS 2004 Slim Bioimpedance Cardiac Analyzing Measuring System, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the NICaS 2004 Slim. Instead, it describes a non-clinical and clinical testing approach to demonstrate substantial equivalence to its predicate device, the NICaS 2001, and to illustrate its improved performance. The core "acceptance" appears to be based on demonstrating superior or at least equivalent performance to the predicate device in relevant measurements.

However, based on the provided text, we can infer a form of acceptance criteria related to its improved readings.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 163 patients for the clinical study. Additionally, 50 readings were taken on a simulator for non-clinical testing.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the device manufacturer is N. I. Medical, Ltd. in Israel, suggesting the study may have been conducted there or internationally. Given a 510(k) summary, it's typically a summary of completed studies rather than a prospective study design being presented.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Clinical Ground Truth: The ground truth for the clinical test set was established by thermodilution. This is an invasive, established method for measuring cardiac output, often considered a gold standard. No "experts" in the human sense were explicitly mentioned for interpreting the thermodilution data, as the method itself directly provides the reference measurement.
   • Non-Clinical Ground Truth: For the non-clinical testing, a "simulator" was used. The ground truth would be the known, controlled parameters set by the simulator itself.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned in the provided text, as the comparison was made against objective measurements (thermodilution for clinical, simulator output for non-clinical).

4. 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:

   • No, an MRMC comparative effectiveness study was not conducted or described. The NICaS 2004 Slim is a device that directly measures parameters (though using sophisticated algorithms), not one that assists human readers in interpreting complex images or data in a diagnostic context that would typically require MRMC studies.

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

   • Yes, the performance described is primarily a standalone algorithm-only performance. The device takes measurements, processes them with its "improved algorithm," and provides hemodynamic parameters. While a human clinician interprets these parameters, the measurement and calculation process itself is automated.

6. The type of ground truth used:

   • Clinical: Thermodilution (a recognized clinical standard/gold standard for cardiac output measurement).
   • Non-Clinical: Simulator output (controlled, known values).

7. The sample size for the training set:

   • The document does not specify a separate "training set" sample size. The focus is on the performance of the device and its algorithm rather than the development of a trained AI model in the modern sense. The "improved algorithm" is mentioned as providing greater mathematical precision, implying refinement, but no details on training data are provided.

8. How the ground truth for the training set was established:

   • Not applicable, as a distinct training set and its ground truth establishment are not discussed in the summary. The "improved algorithm" development process, which might be analogous to training, is not detailed in terms of specific data provenance or ground truth methods.

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