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The NICaS™ electrode is used only in conjunction with the NICaS™ 2001 and all other NICaS™ devices.

The function of the NICaS™ electrode is unchanged from that of the Nicolet Biomedical Instruments Velcro ground strap in the original NICaS™ 2001 cardio-respiratory system,(510(k)K942227) submission, namely, to transmit electrical signals to and from the skin and the NICaS™ 2001 cardiorespiratory system.

The indications for use of the NICaS™ 2001 cardio-respiratory system remain unchanged from those included in the original NICaS™ 2001 cardio-respiratory system, (510(k) K942227), namely, monitoring hemodynamic parameters including stroke volume, stroke index. heart rate, cardiac index, cardiac output, and total peripheral resistance; and the ventilatory parameter, respiratory rate. The device is intended for use in male and female patients with cardiovascular disorders including:

• patients undergoing cardiac catheterization
• cardiac surgery patients
• patients in intensive and cardiac care units
• patients in rehabilitation centers

The NICaS™ Electrodes are fixed to intact skin of the arms and legs of a patient that is to be monitored for cardiac output. The electrodes employ a biocompatable conductive adhesive to maintain their position for up to 24 hours of continuous monitoring. As stated in the original submission, the electrodes conduct a 1.4 mA, 32.5 KHz current to the skin from the NICaS™ 2001 Noninvasive Cardio-Respiratory System (K942227) which uses the principle of bioimpedance to determine various cardiac parameters including cardiac output. The change from the strap type electrodes included in the original submission will permit longer term patient monitoring. The change in electrodes does not require any changes to the NICAS™ 2001 Noninvasive Cardio-Respiratory System itself. The electrodes continue to be attached to the two identified input connectors of the patient module. The patient module also connects with the computer.

The electrode design is similar to the Katecho, Inc. K-Defib/Pace Pediatric Electrode (K954505). The materials and manufacturing methods are the same, therefore no new biocompatability issues are raised. The only change is that the size and shape of the electrode has been modified for ease of use in the clinical setting.

Here's a summary of the acceptance criteria and the studies performed for the NICaS™ Electrode, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: Two studies were conducted. The first study on stability involved "volunteers." The second study on correlation involved "normal volunteers." Specific numbers are not provided.
   • Data Provenance: Both studies were "performed by N.I. Medical." The country of origin for the data is not explicitly stated but can be inferred to be Israel, where N.I. Medical, Ltd. is located. Both studies appear to be prospective as they were specifically performed to evaluate the new electrodes.

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

   • This information is not provided in the document. The studies focused on objective measurements of cardiac output stability and correlation, rather than subjective expert interpretation for ground truth.

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

   • An adjudication method is not applicable and not described. The studies involve direct measurements of cardiac output and comparison, not interpretation that requires adjudication among experts.

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 performed, nor is it applicable. This device is an electrode for bioimpedance measurement, not an AI-assisted diagnostic tool requiring human reader interpretation.

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

   • This question is not directly applicable as the device is an electrode, a hardware component for signal transmission. Its performance is evaluated in conjunction with the NICaS™ 2001 system. The studies described are evaluations of the electrode's physical and electrical properties, and its impact on the system's cardiac output measurements. The "standalone" performance here relates to its ability to maintain stable and comparable electrical signals for the system to process.

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

   • The "ground truth" for the studies was based on the measurement of cardiac output data.
     • For the stability study: Consistency of cardiac output measurements over time within the same subject.
     • For the correlation study: Comparison of cardiac output measurements obtained using the new electrodes against those obtained using the established predicate electrodes (Nicolet Biomedical electrodes). The predicate device's measurements serve as the reference or "ground truth" for comparison.

7. The sample size for the training set:

   • Not applicable. This device is an electrode; there is no machine learning model or algorithm that requires a "training set" in the context of its function.

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

   • Not applicable, as there is no training set mentioned for this device.

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