(76 days)
The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine.
The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices.
- The SentrySuite software replaces the JLAB software and got a brand-new graphical surface.
- Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software
- The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes.
- SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software.
- SentrySuite can be operated on workstations and on servers.
Measurements:
- Spiormetry
- Flow Volume
- Maximal Voluntary Ventilation (MVV)
- Incentive Spirometry
- R-Occlusion
- Impulse oscillometry
- Bronchial test
- FRC Helium Rebreathing
- Real Time Single Breath Diffusion
- Intra Breath Diffusion
- Bodyplethysmography
- Respiratory Drive P0.1
- PI/PE Max (MIP/MEP)
- Single Breath Diffusion CO/He
The acceptance criteria for the SentrySuite Product Line, specifically for the updated SentrySuite 2.7 software, are based on the statistical correlation of its performance with the predicate JLAB software. The study's objective was to demonstrate substantial equivalence by showing that the new software generates results that are highly correlated with the predicate software.
Here's a breakdown of the requested information:
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Statistical Correlation (p-value): For each key parameter (DLCO, VA, Vin for Diffusion Single Breath CO/He; TLC, FRCpl, RV, sReff, Reff for Bodyplethysmography; P0.1 for Respiratory Drive; PI/PE Max for PI/PE Max (MIP/MEP)), the one-tail p-value for the bivariate correlation test between the SentrySuite 2.7 software and the predicate JLAB software must be |
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).