(92 days)
The ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test PFT system and the Morgan transfer test benchmark PFT system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is for use in pulmonary function testing and reports.
ComPAS2 is designed to interface with various pieces of hardware (previously cleared pulmonary function testing devices, K142812, K042595, K022636, K953990, K013752) to capture clinical data in the performance of clinical testing. Those data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SOL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).
ComPAS2 is designed to operate with pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation (MVV), respiratory muscle strength, cough peak flow, lung volume sub-divisions (by helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include a task manager in order to manage patient data for reporting, manual entry in order to input additional information and historical data in order to analyze data for trending and reporting.
The user performs daily quality checks/calibrations prior to performing any tests. Once the test subject enters the Pulmonary Function Testing lab, foundation biographical information (Unique ID, Name, DOB) are either entered by the user, recalled or received in and order via Health Level 7(HL7) message from the information system. The functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience.
Encounter information is added at the time of testing such as height, weight, diagnosis and physician. Test capability depends upon the Pulmonary Function Testing device being employed. Completed test information can be printed and handed to the physician for interpretation or data can be routed to the EMR (Electronic Medical Record).
ComPAS2 software connects using USB-powered desktop pulmonary function testing devices for the purpose of creating, adding and recalling subjects and performing pulmonary function testing on those subjects to aid in the measuring of the effect of lung disease on pulmonary function.
The ComPAS2 software is intended to interface with existing pulmonary function testing hardware to capture and display clinical data related to static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions, single breath diffusion, airway resistance, and distribution with lung clearance index closing volume, for use in pulmonary function testing and reports.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a typical quantitative format for device performance. Instead, it details that the ComPAS2 device has identical functionality and indications for use as its predicate device, ComPAS (K021200). The comparison table highlights that key functional performance parameters are the same between ComPAS and ComPAS2. Since ComPAS was already cleared by the FDA, the demonstration of identical functionality and adherence to the same established standards (ATS/ERS) serves as the basis for substantial equivalence.
| Performance Metric | Acceptance Criteria (Predicate ComPAS) | Reported Device Performance (ComPAS2) |
|---|---|---|
| Flow Measurement | Pneumotachograph | Pneumotachograph |
| Flow Range | -18 L/s to +18 L/s | -18 L/s to +18 L/s |
| Volume Accuracy | +/- 1% | +/- 1% |
| Flow Accuracy | +/- 2.5% | +/- 2.5% |
| Sampling Rate | 100 - 300 samples per second | 100 - 300 samples per second |
| Number of Tests per Session | 8 – Pre bronchodilator, 8 – Post Bronchodilator, Multiple Challenge Levels | 8 – Pre bronchodilator, 8 – Post Bronchodilator, Multiple Challenge Levels |
| Flow Calibration | 3L calibration syringe | 3L calibration syringe |
| Units | Metric or Traditional | Metric or Traditional |
| ATS/ERS Review of Acceptability | Yes | Yes |
| ATS/ERS Review of Repeatability | Yes | Yes |
| Standards Compliance | ATS, ERS, SSD & OSHA | ATS, ERS, SSD & OSHA |
| Quality Control | Data stored for reporting and tracking purposes | Data stored for reporting and tracking purposes |
| Hardware Communication | USB | USB |
| Database | Microsoft SQL | Microsoft SQL |
Note: The key "acceptance criterion" implicitly demonstrated is that ComPAS2 functions identically and adheres to the same established performance standards as the predicate device (ComPAS K021200), which was already cleared. The minor changes (updated operating system compatibility and localization support) are considered not to introduce new risks or alter the fundamental performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states that ComPAS2 software testing involved "developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls." It specifically mentions "results from ComPAS2 testing of the American Thoracic Society's 26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995)".
Sample Size:
- For flow/volume validation, 26 waveform loops from the American Thoracic Society were used.
- The document does not specify a distinct 'test set' sample size in terms of patient data but rather focuses on testing the software's ability to process and display data in congruence with existing hardware and standards.
Data Provenance:
- The 26 waveform loops are derived from a standard set (American Thoracic Society). The original provenance (country of origin, retrospective/prospective) of these standardized waveforms is not detailed in this document, but they represent a recognized benchmark for spirometry validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish "ground truth" for the test set in the context of this software clearance. The validation relies on standardized waveforms and comparison with the predicate device's existing results. The "ground truth" for the performance metrics (e.g., flow accuracy, volume accuracy) is inherently established by the widely accepted ATS/ERS standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There was no mention of an adjudication process by multiple experts for establishing ground truth for the software's performance, as the validation relied on standardized waveforms and comparison to predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The ComPAS2 software is a data acquisition and display system for pulmonary function tests, not an AI-driven interpretive aid for human readers. Its validation focuses on accurate data processing and display, matching the predicate device.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly conducted, focused on the software's ability to accurately process and display data. The "ComPAS2 software testing activities consisted of developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls." The results were "validated against existing results from ComPAS, the aforenamed predicate device." This indicates the software was tested independently to ensure its calculations and outputs matched expected results based on the predicate and established standards.
7. Type of Ground Truth Used
The ground truth used for validating ComPAS2's performance appears to be a combination of:
- Established industry standards: Specifically, the American Thoracic Society and European Respiratory Society's Standardization for Lung Function Testing (ATS/ERS 2005, and later updates from 2017). These standards define acceptable accuracy and performance for spirometry.
- Standardized mechanical and biological controls/waveforms: The mention of "26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995)" points to using standardized, known input data against which the software's outputs are compared.
- Predicate device results: The software's output was validated against "existing results from ComPAS," implying that the previously cleared and validated performance of the predicate serves as a benchmark for equivalence.
8. Sample Size for the Training Set
The document does not mention a "training set" because ComPAS2 is not described as a machine learning or AI algorithm in the context of typical AI device development that requires a training set. It is a software redesign of an existing pulmonary function testing application. Its development involves standard software engineering practices rather than algorithmic training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no mention of a training set or machine learning algorithm.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).