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The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The alternative NICOM Sensors are disposable electrodes used in conjunction with the Cheetah Medical NICOM signal processing product line.

The Cheetah Reliant non-invasive CO monitor (NICOM) is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

Cheetah Medical's alternative NICOM Sensor is a double electrode sticker. Within each sticker, one electrode is used to inject the a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and finally the electrical bio-reactance waveform constructed.

Acceptance Criteria and Device Performance Study for Cheetah NICOM System

This analysis is based on the provided 510(k) summary for the Cheetah NICOM System (K101487).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for the alternative NICOM Sensors. However, the performance is evaluated against the established performance of the predicate device. The primary acceptance criterion appears to be Substantial Equivalence to the legally marketed predicate NICOM electrodes (K071631 and K083093).

2. Sample Size and Data Provenance

• Sample Size for Test Set: 15 patients.
• Data Provenance: The study was conducted at Cheetah-Medical Ltd., suggesting it was likely conducted in Israel, where Cheetah Medical Ltd. is located. The study is prospective, as patients "underwent cardiac output evaluation."

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth in this study. The implication is that the "ground truth" for comparison was the performance of the predicate NICOM electrodes themselves, as they were the benchmark for substantial equivalence.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The comparison was directly between the alternative sensors and the predicate sensors on the same patients.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was described. This study focused on the performance of a medical device (alternative sensors) compared to its predicate, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The study described is a standalone performance study in the sense that it evaluates the performance of the alternative NICOM sensors in measuring cardiac output, comparing its readings directly to those obtained using the predicate NICOM electrodes. It's not a human-in-the-loop study.

7. Type of Ground Truth Used

The ground truth used for the clinical testing was the measurements obtained from the legally marketed predicate device (NICOM electrodes cleared for use with the Reliant System). This approach aims to demonstrate that the new device provides comparable results to an already approved device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the alternative NICOM Sensors in the context of this 510(k) summary. The clinical testing described directly serves as the "test set" for demonstrating equivalence. If a machine learning algorithm was involved, information about its training would typically be provided separately, but this document focuses on the sensor's performance.

9. How Ground Truth for the Training Set Was Established

As no specific training set is mentioned in the provided text in the context of demonstrating substantial equivalence, the method for establishing ground truth for a training set is not described.

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The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of Ltr/Min, and was cleared under K042144.

NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.

The Cheetah NICOM is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

Cheetah Medical's NICOM electrode is a double electrode sticker. Within each sticker, one electrode is used to inject a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bio-reactance waveform constructed.

The provided text describes a 510(k) summary for the Cheetah NICOM System and its electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for the device itself.

However, based on the information provided, we can infer and construct some of the requested elements, particularly regarding the equivalence of the NICOM electrodes.

Here's an analysis based on the supplied text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics for the Cheetah NICOM System's cardiac output measurement functionality, nor for the NICOM electrodes in isolation of their primary function.

Instead, the primary "acceptance criterion" demonstrated in the clinical testing of the NICOM electrodes is substantial equivalence to the 3M Health Care Red Dot electrodes when used with the NICOM System.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Study for NICOM Electrodes Equivalence:
  • Sample Size: 10 subjects.
  • Data Provenance: Not explicitly stated, but the context of the other clinical studies (Lonestar Heart Center, Amarillo, Texas, US) suggests a prospective study conducted in the United States. The study involved measuring cardiac output in these subjects using both NICOM electrodes and the predicate 3M Red Dot electrodes.
• Clinical Safety Studies (though not performance test sets per se):
  • Sample Size:
    • 119 consecutive patients (postoperative cardiac surgery).
    • 36 patients (stress testing).
  • Data Provenance: Lonestar Heart Center, Amarillo, Texas, US for the 36 patients. The location for the 119 patients is not specified but is likely also in the US given the context of a US-based submission. These appear to be prospective studies focused on safety/adverse events.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical studies. For the electrode equivalence study, "cardiac output was measured in 10 subjects." The ground truth for cardiac output itself would likely be derived from a reference method (e.g., PAC - Pulmonary Artery Catheter, mentioned in another study) or the comparative device (3M Red Dot electrodes). There is no mention of expert consensus for ground truth on the electrodes' performance.

4. Adjudication Method for the Test Set

Not specified in the provided text. The nature of the clinical "testing" for electrode equivalence ("Cardiac output was measured in 10 subjects with the NICOM System using the NICOM electrodes and using the 3M Health Care Red Dot electrodes") suggests a direct comparison, rather than an adjudication process requiring multiple reviewers for a diagnostic finding.

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 document describes a medical device (cardiac output monitor and its electrodes), not an AI algorithm intended to assist human readers in image interpretation or diagnosis. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is outside the scope of this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The Cheetah NICOM System is a medical device that measures physiological parameters. Its "performance" is inherent to the device's ability to measure cardiac output, not an algorithm's standalone diagnostic ability in the way an AI might operate. The system itself operates "standalone" in its measurement function, but it's a device measurement, not an algorithm interpreting data that a human would then review.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the NICOM electrodes' equivalence study, the ground truth appears to be based on the measurements obtained using the predicate device (3M Health Care Red Dot electrodes) when used with the NICOM System. The direct comparison between the new electrodes and the predicate electrodes provides the basis for demonstrating equivalence in cardiac output measurements. Another clinical study mentions "patients requiring PAC," suggesting that a Pulmonary Artery Catheter (PAC) might serve as a reference standard for cardiac output measurements in some contexts, but this isn't explicitly tied to the ground truth for electrode equivalence.

8. The Sample Size for the Training Set

• Not Applicable. This document does not mention any machine learning or AI components that would require a distinct training set. The device's operation is based on bio-impedance measurements and signal processing, not a trained algorithm in the modern AI sense.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no mention of a training set or machine learning, this question does not apply.

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The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of [Ltr/Min].

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography.

This document is a 510(k) clearance letter for the Cheetah NICOM System. It indicates that the device has been cleared by the FDA as substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or the study that proves the device meets those criteria.

The letter itself is a regulatory approval, not a scientific study report. To find the information requested, you would typically need to refer to the original 510(k) submission documentation, which is not provided here.

Therefore, I cannot provide the requested information from the given text.

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