(242 days)
The Vyntus/SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. 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 future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).
The Vyntus CPX system is an accurate and reliable system that allows the determination of a subjects' metabolic response while exercising. It is a stationary, mains powered ergospirometry system. The system records the data breath-by-breath. The breath-by-breath data is collected through a facemask or mouth-piece and is sent to a host computer system via cable connection. The digital volume transducer (DVT) measures the gas volume in- and expired. Gas samples are continuously drawn from a location very close to the mouth (between DVT and the face-mask or mouth-piece). The gas samples are dryed by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations the oxygen uptake and the CO2 production (V'O2 and V'CO2) are calculated by the software. The workload protocol selected by the user will control the ergometer device accordingly and the changes in the above vital signs due to the change in workload are recorded. All data is stored together with the patient and test data in the database for later evaluation and printing.
The provided document is a 510(k) Summary for the Vyntus/SentrySuite product line, a pulmonary-function data calculator. This type of document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than providing a detailed study report of accuracy relative to a specific ground truth.
Therefore, many of the typical acceptance criteria and study details for AI/device performance metrics (like sample size for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, or specific types of ground truth like pathology) are not applicable or not explicitly stated in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implied by the "Accuracy" column for each parameter, representing the desired performance. The reported device performance is presented as meeting these desired accuracies.
| Parameter | Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) |
|---|---|---|
| Ergospirometry | ||
| Ventilation (V'E) | 2% or 0,5 L/min | 2% or 0,5 L/min |
| O2 uptake (V'O2) | 3% or 0,05 L/min | 3% or 0,05 L/min |
| CO2 output (V’CO2) | 3% or 0,05 L/min | 3% or 0,05 L/min |
| RER | 4% or 0.04 | 4% or 0.04 |
| Volume Sensor | ||
| Volume | 2% or 50 mL | 2% or 50 mL |
| Flow | 3% or 70 mL/s | 3% or 70 mL/s |
| O2 Analyzer | ||
| O2 Accuracy | 0,05% | 0,05% |
| CO2 Analyzer | ||
| CO2 Accuracy | 0,05% or 1% (for proposed) | 0,05% or 1% (for proposed) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a sample size for the accuracy testing. It refers to "Measurement effectiveness & accuracy according golden standard 'Douglas bag'" which indicates the method of testing, but not the number of tests or subjects.
- Data Provenance: Not specified. The company (CareFusion Germany 234 GmbH) is based in Germany, suggesting testing might have been done there. The testing is non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for the performance parameters (like O2 uptake, CO2 output, flow, volume) is established through a "golden standard 'Douglas bag'" and other calibrated measurement techniques, not expert review of images or data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. This device measures physiological parameters, and accuracy is determined by comparison to a "golden standard" reference, not through human adjudication of differing interpretations.
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:
- MRMC Study: No, an MRMC study was not done. This device is a measurement system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the accuracy testing described in the tables (Ergospirometry and Volume Sensor parameters) represents the standalone performance of the device's measurement capabilities. The device's software calculates these parameters.
- The "Summary Discussion of Bench Performance Data" states: "The CareFusion Vyntus CPX cardio pulmonary exercise system passed all specified test requirements. The validation and verification testing confirmed this device meets user needs and design inputs for a CPET system. Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above."
- This confirms the device, including its algorithms, performs according to the specified accuracies.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for the accuracy testing was established using a "golden standard 'Douglas bag'" method for measurement effectiveness and accuracy. This refers to a highly accurate reference method for collecting and analyzing breathed gases. Other parameters (volume, flow) would be compared against calibrated reference instruments.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable/not stated. This document describes a medical device for measuring physiological parameters, whose core functionality relies on physical sensors and established scientific principles for calculation. It is not an AI/Machine Learning model that typically requires a discrete training set in the way a diagnostic AI would. The "software life cycle" according to ISO 62304 is mentioned, implying robust software development and verification, but not a "training set" in the context of data-driven AI.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As explained above, the concept of a "training set" and its associated ground truth establishment is not typically relevant in the context of this type of device's regulatory submission where the focus is on sensor accuracy and calculation validity against known physical standards.
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).