(119 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 and APS Pro 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
Carefusion Germany 234 GmbH's SentrySuite Product line is a software modification that replaces the JLAB software for existing hardware (MasterScreen Pneumo, MasterScreen IOS, APS Pro) used for pulmonary function testing. The 510(k) submission (K111053) focused on demonstrating substantial equivalence to the predicate devices with the JLAB software.
No specific acceptance criteria or a dedicated study demonstrating the device meets acceptance criteria are explicitly detailed in the provided K111053 summary.
However, the submission outlines the general approach taken to ensure the new software performs at least as well as the predicate devices, focusing on the equivalence of its functionality and adherence to relevant standards.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not include a table of explicit acceptance criteria with quantitative performance metrics for the SentrySuite Product line. Instead, it states that the SentrySuite software provides the functionality currently available on the MasterScreen devices using the JLAB software and that "The measurement programs for the medical applications for each device remain the same."
The declaration of substantial equivalence implies that the SentrySuite software is expected to maintain the performance characteristics of the predicate devices. The performance specifications listed in the comparison table (3) under the "Perfor-mance specifica-tion (measure-ment programs)" indicate the types of measurements the device can perform, which are "identical" to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify a sample size for a test set or data provenance in direct relation to evaluating the performance of the SentrySuite software against acceptance criteria. The focus of this 510(k) appears to be on the software change, and the demonstration of equivalence is primarily based on the functional identity of the measurement programs and adherence to software development and risk management standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable and not provided in the context of this 510(k) submission. The device is a pulmonary function testing system that measures parameters. The "ground truth" for such devices typically comes from established calibration standards and physiological measurements, not expert interpretation of results for diagnostic accuracy in the way an imaging AI might.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted and is not relevant for this type of device. The SentrySuite Product line is a measurement and data collection system, not an AI diagnostic tool requiring human reader interpretation with or without AI assistance.
6. Standalone Performance Study
While not explicitly called a "standalone performance study" in the common sense of AI algorithm evaluation, the software was developed according to:
- CareFusion Design and Development SWI (0301-5001-000-SWI)
- IEC 62304 (Software life-cycle processes)
- IEC 62366 (Usability) standard
This indicates internal verification and validation activities specific to the software's functionality, safety, and usability. The summary states: "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." This suggests that the internal testing aimed to confirm that the new software performs measurements equivalently to the old software, effectively serving as a standalone evaluation of the new software's capabilities.
7. Type of Ground Truth Used
The concept of "ground truth" as pathology or outcomes data is not directly applicable here. For pulmonary function devices, the "ground truth" would relate to the accuracy and precision of the measurements obtained (e.g., spirometry, flow volume, MVV) against recognized calibration standards or accepted physiological models. The submission implies that the measurement programs being "identical" to the predicate devices' programs means they adhere to the same established physiological measurement principles and accuracy.
8. Sample Size for the Training Set
There is no mention of a training set sample size. This device is a software update for a measurement system, not a machine learning or AI model that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no indication of a training set being used for this software modification. The software's functionality is based on established algorithms for pulmonary function measurements, not on learned patterns from a dataset.
Summary of the Study and Evidence for Equivalence:
The primary "study" and evidence presented in K111053 to demonstrate the device meets acceptance criteria (implied as being equivalent in function and safety to the predicate devices) are through:
- Comparison to Predicate Devices: A detailed comparison table (3) is provided, highlighting that the "SentrySuite Product line" has identical indications for use, patient population, hardware, performance specifications (measurement programs), energy type, patient-contacting parts, sterilization, and software network options compared to the predicate devices, except for the software name itself (SentrySuite replaces JLAB).
- Software Development Standards: Adherence to established software development and usability standards (IEC 62304, IEC 62366) and the company's internal design and development procedures (CareFusion Design and Development SWI).
- Risk Analysis: A Failure Modes and Effects Analysis (FMEA) according to ISO 14971 was performed to assess the impact of the new software.
- Claim of Functional Equivalence: The submission explicitly states: "Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software." and "The measurement programs for the medical applications for each device remain the same."
Essentially, the document argues that because the new software performs the same functions using the same measurement programs on the same hardware as the legally marketed predicate devices, and was developed under stringent quality and risk management standards, it is substantially equivalent and thus meets the implicit acceptance criteria of being safe and effective for its intended use, performing at least as well as the predicate devices.
§ 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).