Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device