(269 days)
Ascent Cardiorespiratory Diagnostic Software 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 or a mask. The test can be viewed on-line with the help of a computer screen and can be printed after the test results can be saved for further referral or report generation purposes.
For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency.
The product can be utilized for patients from 4 years old 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.
In conjunction with pulmonary diagnostic hardware, Ascent software, a Windows desktop application developed using Microsoft's NET Framework, is used to collect data pertaining to the patient's degree of obstruction, lung volumes, and diffusing capacity. It is also used to present the collected lung diagnostic information so that it can be checked for quality and interpreted by a qualified physician, usually a pulmonologist.
The core purpose of the software is to facilitate pulmonary function testing in patients who may be suffering from pulmonary illnesses like Chronic Obstructive Pulmonary Disease and asthma. The software will interact with connected Medical Graphics Corporation diagnostic devices to perform the desired pulmonary function tests on the patient by a professional pulmonary function technologist. The application will display both actual and derived test variables to the user after a test is performed for purposes of data review.
Here's a breakdown of the acceptance criteria and study information for the Ascent Cardiorespiratory Diagnostic Software, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a typical quantitative pass/fail format within a table. Instead, it describes general validation and performance testing. However, we can infer the performance objectives and how they were met.
| Acceptance Criteria (Inferred from Validation) | Reported Device Performance |
|---|---|
| Software Functionality and Safety (General) | Fulfills intended use/indications of use. |
| Compliant with medical device software standards & guidance | Validated per ISO 14971 and IEC 62304. |
| Performance of key pulmonary function parameters within acceptable limits | Physiologic performance validation testing conducted for FVC, MVV, FRC, SVC, DLCO, VA, and TGV. Results support intended use. |
| System-level tests, performance tests, and safety testing based on hazard analysis. | Validation testing conducted, including system-level, performance, and safety tests. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: 38 test sessions.
- Data Provenance: The subjects for these test sessions were "from seven to sixty-three years old." The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions that the software presents data to a "qualified physician, usually a pulmonologist, for diagnostic interpretation," but this refers to the intended use, not the ground truth establishment for the validation study itself.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "physiologic performance validation testing" implies direct measurement comparison rather than expert consensus on interpretive tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not explicitly mentioned or described as being performed. The study focused on the performance of the software and integrated hardware, not on the impact of the software on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the "physiologic performance validation testing" and "software validation testing" described seem to represent a standalone assessment of the device's ability to measure and process pulmonary function parameters. The device's core function is data collection and analysis, which occurs without direct human interpretation assistance during the measurement phase. The overall intention is for a "qualified physician" to interpret the results generated by the algorithm.
7. The Type of Ground Truth Used:
The document doesn't explicitly state "ground truth" in the context of reference standards. However, the nature of the device (pulmonary function software) implies that the ground truth for "physiologic performance validation testing" would be the physical measurements obtained from the connected hardware devices for various pulmonary function parameters (e.g., airflow, volume, gas concentrations). The accuracy of these measurements would be compared against expected values or highly accurate reference standards, though these specific reference standards are not detailed in the provided text.
8. The Sample Size for the Training Set:
The document does not mention any training set sample size or details about a training set. This is likely because the device, as described, is not an AI/machine learning model that typically requires a discrete training phase with labeled data. It appears to be a software system for data acquisition, processing, and display based on established physiological algorithms and hardware interaction.
9. How the Ground Truth for the Training Set Was Established:
As no training set is discussed, there is no information on how its ground truth might have been established.
§ 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).