(218 days)
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.
| Criterion | Reported Performance |
|---|---|
| NICOM Electrodes Equivalence (Clinical) | "The results demonstrate that the NICOM electrodes are substantially equivalent to the 3M Health Care Red Dot electrodes when used with the NICOM System." |
| No Adverse Events Reported (Clinical) | "119 consecutive patients requiring PAC in the immediate postoperative period following cardiac surgery - No adverse events were reported." |
| "36 patients undergoing cardiac output evaluation during stress testing in Lonestar Heart Center, Amarillo, Texas, US. No adverse events were reported." (This implies safety, a key aspect of acceptance for medical devices) | |
| ANSI/AAMI EC12:2000/(R)2005 Compliance (Bench) | "Electrodes were tested per ANSI/AAMI EC12:2000/(R)2005; Disposable ECG electrodes, 3ed." (Implies electrical performance and safety acceptance) |
| ISO-10993 Compliance (Biocompatibility) | "Biocompatibility was confirmed per ISO-10993 standard; Biological Evaluation of Medical Devices." (Implies biocompatibility and safety acceptance) |
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.
- Sample Size:
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.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).