(59 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) and heart rate. 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), electrical impedance of the chest cavity (Z0) 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 Cheetah Reliant with NIPB functionality is a modification of the Cheetah Reliant device cleared under K072662. The significant modification discussed in this 510(k) submission is the addition of a Non Invasive Blood Pressure (NIBP) module to the system which involved updating the user interface to allow operating the NIBP module and for displaying the results and saving them within the device's database. The NIBP Module is the Advantage mini OEM BP™ module (Model 2 Mini), manufactured by SunTech Medical Inc. (Morrisville, NC, USA). The ADVANTAGE mini OEM BPTM Module Series is an oscillometric OEM blood pressure system. The module is controlled via software commands issued from a host system through an asynchronous serial data port (factory configurable to Logic Level or RS-232). All Module operations must be initiated by the Host system (Reliant). The module is designed to take blood pressure measurements (systolic, diastolic, and heart rate) on demand. After each blood pressure measurement, the Module discards the previous blood pressure results.
Here's a breakdown of the acceptance criteria and study information for the Cheetah Reliant with NIBP functionality, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NIBP functionality are based on compliance with ANSI/AAMI SP10:2002. This standard sets requirements for automated sphygmomanometers. While the document broadly states compliance, it does not provide specific numerical acceptance limits for parameters like accuracy and precision (e.g., mean difference and standard deviation of blood pressure readings compared to a reference) or the detailed reported device performance against those specific limits.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10:2002 Compliance | Clinical testing performed verifying conformance for adult subjects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only states "clinical testing was performed...for adult subjects." It does not specify the exact number of subjects or measurements included in the test set.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the medical device submission context, it would typically be prospective clinical data collected specifically for the regulatory submission.
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. For NIBP validation against ANSI/AAMI SP10, ground truth is typically established by trained observers (auscultators) using a mercury sphygmomanometer, often with a double-blinded approach. The document does not detail how many such observers were used or their specific qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document. For NIBP studies conforming to ANSI/AAMI SP10, there isn't a typical "adjudication" in the sense of expert consensus on diagnostic interpretations. Instead, the standard outlines specific procedures for simultaneous or sequential measurements by a trained observer and the device, with statistical analysis of the differences.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this device. The submission focuses on the performance of the non-invasive blood pressure (NIBP) module against an industry standard (ANSI/AAMI SP10:2002), not on comparing human reader performance with and without AI assistance for interpretation. The Cheetah Reliant with NIBP is a measurement device, not an AI interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was conducted for the NIBP function. The assessment against ANSI/AAMI SP10:2002 involves comparing the device's automated measurements (algorithm only) directly against a reference standard (likely observer auscultation). There is no "human-in-the-loop" component for the NIBP measurement itself; the device automatically measures blood pressure.
7. The Type of Ground Truth Used
For the NIBP functionality, the ground truth would be established through simultaneous or sequential measurements taken by trained observers using a reference standard (e.g., mercury sphygmomanometer or an equivalent validated device), as outlined by the ANSI/AAMI SP10:2002 standard. This is not "expert consensus" in the diagnostic interpretation sense, nor is it pathology or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set for the NIBP module. The NIBP module (Suntech Medical Inc. Model 2 Mini) is an OEM component. While such components would have been developed and internally validated by Suntech Medical (which would involve development/training data), this information is not part of Cheetah Medical's 510(k) submission, which focuses on the integration and verification of the existing module within their system.
9. How the Ground Truth for the Training Set Was Established
Since a training set for the NIBP module's algorithm is not discussed in this submission, the method for establishing its ground truth for training purposes is not provided. This information would typically reside with the original manufacturer of the NIBP OEM module (SunTech Medical Inc.).
§ 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.