(117 days)
The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.
The Cheetah Reliant is a portable, non-invasive, Cardiac Output measurement system. The Cheetah Reliant 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.
Here's a breakdown of the acceptance criteria and study information for the Cheetah Reliant device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness of the device | Bench testing protocols, module, integration, and system level testing demonstrated safety and effectiveness. |
| Performance vs. Predicate Device (first generation NICOM System) | Bland-Altman analysis showed symmetrical distribution for CO measurement differences around the bias, and a confidence level of 95% when compared to the 1st generation NICOM System. The device was found to be substantially equivalent. |
| Compliance with relevant standards | Mechanical and EMC testing was conducted per IEC/EN60601-1, UL 60601-1, and CSA C22.2 No. 601.1. |
| Ability to monitor and display Cardiac Output in Ltr/min | The study implicitly demonstrates this, as it compares the device's CO measurements to the predicate. The intended use explicitly states this capability ("intended to monitor and display a patient's Cardiac Output in units of Ltr/min"). |
| No adverse health effects or safety risks | Concluded that the device "presents no adverse health effects or safety risks to patients when used as intended." |
| Substantial equivalence to predicate device | "The device was extensively tested - both Bench and in the human - against its predicate, and was found to be substantially equivalent," and the FDA's letter confirms the determination of substantial equivalence (though this is the FDA's regulatory decision, not directly a study finding). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set 1 (Bench Testing - Raw Data):
- Sample Size: 44 patients
- Data Provenance: Retrospective, Intensive Care Unit of Ambroise Pare Hospital in France.
- Test Set 2 (Human Testing):
- Sample Size: 23 volunteers
- Data Provenance: Prospective (implied by "testing in the Human (23 volunteers)"). Country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the comparative study was the measurements from the 1st generation NICOM System (K042144), which is the predicate device. It's not clear if human experts were involved in establishing the "truth" for either the predicate or the new device's measurements, beyond the doctors/nurses using the equipment in the ICU.
4. Adjudication Method for the Test Set
This information is not provided in the document. The study describes a "comparative study" and "Bland-Altman analysis," which is a statistical method for comparing two measurement techniques, not an adjudication method for reconciling expert opinions.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is a Cardiac Output monitoring system, not an AI-based diagnostic tool that assists human readers/interpreters of medical images or data in the traditional sense of an MRMC study. The comparison was between two devices measuring the same physiological parameter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Partially, yes. The device itself is described as "standalone" in the sense that it's compact and uses an embedded processing unit, replacing an external laptop PC. The study compares the performance of this standalone device (Cheetah Reliant) against another device (1st generation NICOM System). The "algorithm only" aspect is inherent to its function as an automated measurement device. There isn't a human-in-the-loop component being evaluated in the study; it's a device-to-device comparison.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" for this comparative study was the measurements obtained from the 1st generation Cheetah NICOM System (K042144), which served as the predicate device. The study aimed to show substantial equivalence to this established device. It's a comparison to a "standard device measurement" rather than an independent expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not provided in the document. The document describes testing and validation, but not the development or training of an algorithm in the machine learning sense. The device is based on existing bio-impedance measurement techniques.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as there's no mention of a "training set" or algorithm training in the context of machine learning. The device's operation is based on established bio-impedance principles, not on a trained AI model.
§ 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.