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510(k) Data Aggregation
(35 days)
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).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate NICOM electrodes | "The data demonstrated that the alternative NICOM Sensors are substantially equivalent to the NICOM electrodes cleared for use with the Reliant System." |
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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