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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria	Reported Device Performance
Cardiac Output	Correlated with standard invasive thermodilution technique. (Specific correlation coefficient, bias, precision, or agreement limits are not provided in the text.)
Respiratory Rate	Correlated with Horizon 2000 Physiological Monitor. (Specific correlation coefficient, bias, precision, or agreement limits are not provided in the text.)
Safety	Designed to meet IEC 601-1-1 and UL 544 medical safety standards; tested and approved by TUV. (This implies an acceptance criterion of meeting these standards).

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.

Summary

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K942227

JUN 28 1998

510(k) Summary

Submitter's Name:

N.I. Medical, Ltd. 31 Habarzel Street Tel Aviv 69710 Israel Phone: 972-3-492124 Facsimile: 972-3-6482401

Contact Person:

June 19, 1996 510(k) Summary Date:

Device Name: NICaS 2001 Noninvasive Cardio-Respiratory System

Mr. S. Pilovski, C.E.O.

Common Name: Noninvasive Cardio-Respiratory Monitor

Classification Name: Impedance plethysmography (21 CFR 870.2770)

Predicate Device: BoMed's NCCOM3-R7 Monitor

Device Description: 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.

Intended Use:

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Precaution:

The effective use of the NICaS 2001 has not been established in the following clinical conditions:

- Severe valvular disease
- Severe septic shock
- Severe aortic aneurysms
- Occlusion of the abdominal aorta or aortic bifurcation
- Peripheral arterial disease
- Coarctation of the aorta
- Chaotic breathing patterns
- Intra cardiac shunts
- Severe arrhythmias
- Dialysis

Comparison of Technological Characteristics:

The NICaS 2001 and the BoMed NCCOM3-R7 derive parameters such as stroke volume, cardiac output and other related cardiac parameters by analyzing the impedance changes in the body as influenced by the pumping action of the heart. A modified Kubicek algorithm is used in both devices.

Differences between the NICaS 2001 and the BoMed NCCOM3-R7:

The NICaS 2001 measures total body impedance, which includes both the peripheral and the thorax areas, while BoMed measures only thoracic impedance. This methodology is based on modification of the Kubicek algorithm, the inclusion of patient data (i.e., weight and height), so that a final analysis can provide parameters relative to total body measurement and not only thoracic parameters.

The NICaS 2001 technology allows the display of the respiratory wave as an optional reference for the clinician.

The following parameters are included in the BoMed NCCOM3-R7 but are not displayed on the NICaS 2001: dZ/dt, pre ejection time, ejection time, peak flow, ejection fraction and end diastolic volume. The thoracic fluid index (TFI) is not available by the NICaS 2001 because the device can not distinguish between the thorax and the peripheral; they are measured together in the NICaS 2001. The TFI is not needed for any other calculation.

Safety and Effectiveness Information

The NICaS 2001 was designed to meet the IEC 601-1-1 and UL 544 medical safety standards. It was tested and approved by TUV.

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Data collected from a study conducted by Dr. H. Miller at the Ichilov Hospital, Israel, correlated cardiac output by the NICaS 2001 with the standard invasive technique of thermodilution. Data collected from a study conducted by Dr. Michael Luchansky at the Tel Aviv Medical Center correlated the respiratory rate measured with the Horizon 2000 Physiological Monitor with the NICaS 2001.

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.