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The NICaS CS is intended to monitor and display a patients hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, total peripheral resistance, and the Granov-Goor Index), in males and females with known or suspected cardiac disorders needing cardiac assessment.

The NICaS (non-invasive cardiac system) CS 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) CS is an impedance device which is unique in its use of a laptop computer as part of a technology for noninvasively 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 ΔR, and the baseline body resistance is R (Ω). 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 an analysis of the provided 510(k) summary for the NICaS CS device, breaking down the acceptance criteria and study details:

Acceptance Criteria and Device Performance for NICaS CS

The provided document does not explicitly state numerical "acceptance criteria" for the NICaS CS device in the format of a typical performance table with thresholds. Instead, the clinical testing section describes how the device's performance was validated against a "gold standard technology" (2-Dimensional Echo-Cardiography) for assessing left ventricular dysfunction and normal function. The primary evidence presented for substantial equivalence is a comparison to predicate devices, particularly the BioZ Hemodynamic Monitor, focusing on the Granov-Goor Index's medical equivalence to the Systolic Time Ratio (STR) and Heather Index (HI).

Implicit Acceptance Criteria and Reported Performance (based on provided text):

Study Details for NICaS CS

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

   • Sample Size: 60 consecutive studies.
   • Data Provenance: The study was a "Helsinki-approved clinical trial," indicating prospective data collection, likely within a clinical setting. The country of origin for the data is not explicitly stated, but given N. I. Medical, Ltd. is based in Israel and the trial was "Helsinki-approved," it's plausible the study was conducted in Israel or a country adhering to the Declaration of Helsinki for medical research.

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

   • The document states that the ground truth was established by "2-Dimensional Echo-Cardiography," which is referred to as the "gold standard technology."
   • The qualifications of the individuals performing and interpreting the echocardiography, or the number of experts involved in reviewing these results, are not specified in the provided text.

3. Adjudication method for the test set:

   • The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was established by "2-Dimensional Echo-Cardiography," implying that the results from this "gold standard" were taken as definitive for comparison.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described. This study focuses on validating the device's algorithmic performance against a gold standard, not on human-AI synergy or human reader improvement.

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

   • Yes, a standalone performance study was done. The clinical testing describes the "validation of the performance of the new algorithm in the NICaS CDS device" by comparing its assessment of left ventricular dysfunction and normal function directly against 2-Dimensional Echo-Cardiography. This implies the NICaS algorithm's output was assessed independently.

6. The type of ground truth used:

   • The type of ground truth used was "gold standard technology," specifically 2-Dimensional Echo-Cardiography. This is a recognized clinical diagnostic method for assessing cardiac function and morphology.

7. The sample size for the training set:

   • The document does not provide any information about a training set or its sample size. The focus is solely on the validation/test set of 60 studies.

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

   • As no information about a training set is provided, how its ground truth was established is not available in this document.

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