(139 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 on-line 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
The provided text is a 510(k) summary for the SentrySuite Product Line, which is a software for lung function measurements. It describes the device, its intended use, and its comparison to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood in the context of clinical performance evaluation with metrics like sensitivity, specificity, or accuracy.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily by highlighting that the updated SentrySuite software (version 2.5) replaces an older version (2.3) and incorporates the functionality of another predicate device (MasterScreen PFT K072061). The "Summary of Device Testing" section mentions adherence to development standards (CareFusion Design and Development SWI, IEC 62304, IEC 62366) and risk analysis (ISO 14971 FMEA), but these are related to software development and validation processes, not performance evaluation against specific clinical acceptance criteria.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's what can be gathered and what is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on device modifications and substantial equivalence to predicates, not on specific performance metrics or acceptance criteria for those metrics. The performance is implied to be "identical" or "equivalent" to the predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: This information is not provided.
- Data provenance: This information is not provided. The document does not describe any specific clinical or performance test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as there is no description of a clinical or performance test that would require expert-established ground truth.
4. Adjudication method for the test set:
This information is not provided as there is no description of a clinical or performance test that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
This information is not provided. The document does not describe any MRMC study or any study involving human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a "PFT data calculator" and "pulmonary function data calculator," which implies an algorithm-only function. However, no standalone performance study results, in terms of specific metrics, are presented. The "performance specification" listed in the tables refers to the types of measurements the device can perform (e.g., Spirometry, Flow/Volume), not performance metrics like accuracy or reliability.
7. The type of ground truth used:
This information is not provided because specific performance testing against ground truth is not detailed in this submission.
8. The sample size for the training set:
This information is not provided. The document describes software development and changes, but does not mention any machine learning or AI models that would require training data.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of what the document DOES provide regarding "testing":
The "Summary of Device Testing" (Section 5.15) states that:
- The device modification was developed in accordance with CareFusion Design and Development SWI (0301-5001-000-SWI).
- The software was developed according to IEC 62304 (Software life-cycle processes) and IEC 62366 (Usability) standards.
- Risk analysis was performed using FMEA according to ISO 14971.
These are process-oriented validations and risk management activities, typically required for software medical devices, rather than clinical performance studies demonstrating accuracy, sensitivity, or specificity against specific acceptance criteria. The conclusion (Section 5.16) is based on "substantial equivalence" to predicate devices, implying that since the new software maintains identical functionality and performance specifications to previously cleared devices, it is considered safe and effective.
§ 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).