(214 days)
Morgan Scientific's ComPAS2 is a software application intended to be used to compatible Morgan Scientific or thirdparty devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, and research health centers under the supervision of a healthcare provider.
ComPAS2 is a software application designed to provide a secure PC based medical device for creating, adding/recalling subjects, and performing cardio-pulmonary function testing on those subjects. ComPAS2 will interface and link to compatible Morgan Scientific and third-party devices to read, analyze, and display their output to allow the information to be retained with the subject. Current compatible approved devices: TransAir (K953990), SpiroAir (K042595), Body Plethysmograph (K022636), WristOx2 (K102350), tremoFlo (K170185), Pneumotrac (K142812), Micro (K160253), Model 9100 PFT/D1CO (K221030). Data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SQL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).
ComPAS2 is designed to operate with compatible cardio-pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including, but not limited to: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions (such as but not limited to helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include: a task manager to manage patient data for reporting; manual entry to input additional information; and historical data review to analyze data for trending and reporting.
The ComPAS2 device, a software application for diagnostic spirometry, was found to be substantially equivalent to its predicate device, ComPAS2 v2019.1.0 (K190568). The primary "study" proving this substantial equivalence was non-clinical performance testing of the software.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a typical quantitative pass/fail format for each performance metric, but rather highlights that performance testing demonstrated that the subject device met its acceptance criteria. The "reported device performance" is implied to be equivalent to the predicate device's performance, as the core functionality and technical characteristics remain largely the same, and the software was validated against the predicate's results.
However, based on the comparison table and the general description, we can infer some performance aspects:
| Feature/Characteristic | Acceptance Criteria (Inferred from predicate/standards) | Reported Device Performance (ComPAS2 v2022.1.0) |
|---|---|---|
| Clinical Performance | Acquire, analyze, view, store, export, and print measurements of flow, volume, pressure, and gas concentrations from compatible devices for pulmonary function testing; suitable for adults and pediatrics 4 years and older in healthcare environments. Conforms to ATS/ERS guidelines for spirometry, bronchial challenge, diffusion, lung volumes, respiratory pressures, plethysmography, oscillometry, oximetry measurements. | Functions identically to the predicate (ComPAS2 v2019.1.0) in acquiring, analyzing, viewing, storing, exporting, and printing device outputs including measurements of flow, volume, pressure, and gas concentrations. Supports the same range of pulmonary function tests (static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions, single breath diffusion, airway resistance, distribution with lung clearance index closing volume, airwave oscillometry). Conforms to ATS guidelines and specific standards (e.g., ERS/ATS 2017 for methacholine challenge, single-breath carbon monoxide uptake; ERS/ATS 2019 for spirometry). Meets ATS/ERS Review of Acceptability and Repeatability. |
| System Compatibility | Interface and link to compatible Morgan Scientific and third-party devices. Supports Windows 10. Uses MS SQL Server database. | Interfaces and links to compatible Morgan Scientific and third-party devices (e.g., TransAir, SpiroAir, Body Plethysmograph, WristOx2, tremoFlo, Pneumotrac, Micro, Model 9100 PFT/D1CO, VitaloROV/VitaloLab, VitaloQUB). Supports Windows 10 (Windows 8.1 support removed, but this is a technical update not affecting core functionality). Uses MS SQL Server for data preservation. Updated communications code base for generalized device compatibility. |
| Measurement Accuracy | Volume Accuracy: +/- 1% | |
| Flow Accuracy: +/- 2.5% | ||
| Flow Range: -18 L/s to +18 L/s | ||
| Sampling Rate: 100-300 samples per second | Same as predicate: Volume Accuracy +/- 1%; Flow Accuracy +/- 2.5%; Flow Range -18 L/s to +18 L/s; Sampling Rate 100-300 samples per second. These are inherent to the integrated flow measurement devices, which the software processes data from. | |
| Functional Equivalence | Identical functionality to predicate. | The overall functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience. Key sub-systems interact with the database through an API. Includes features like task manager, manual entry, historical data review, subject management, report printing, trending graphs, PFT predicted value equations, population group management, data import/export, database management, color display, configurable login rules, localization support, HTML Help. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing involved "developing test cases and test runs for the performance of end-to-end testing with both biological and mechanical controls." This suggests a series of functional tests and expected outcomes rather than a traditional patient-based clinical study with a specific sample size.
- Data Provenance: The document does not specify the country of origin for any data used in this non-clinical testing. The nature of the testing (bench testing, software validation) suggests it's primarily synthetic or controlled data generated internally, or data from mechanical/biological controls (e.g., spirometer calibration syringes, simulated lung models). The testing was against "existing results from ComPAS2 v2019.1.0," indicating a retrospective comparison to previously established performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this software validation was established by comparing the results of the ComPAS2 v2022.1.0 software to the "existing results from ComPAS2 v2019.1.0," the predicate device, and ensuring compliance with recognized standards (ATS/ERS guidelines). Expertise would have been in the form of engineers, quality assurance personnel, and potentially pulmonologists for clinical interpretation of the standards and expected outputs, but the document does not specify a panel of experts for "ground truth" establishment in the sense of a diagnostic interpretation study.
4. Adjudication Method for the Test Set
Not applicable. This was a software verification and validation study, not a clinical study requiring adjudication of diagnostic outcomes. Validation involved ensuring consistency and accuracy of the new software's outputs against the predicate and established standards.
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
No MRMC comparative effectiveness study was done or described. The device is a software application intended to acquire, analyze, view, store, export, and print device outputs, not to provide AI-assisted diagnoses that impact human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described is a standalone evaluation of the ComPAS2 software application. The "Bench" section explicitly states "software testing activities" and "system level testing to ensure that the product is capable of meeting the intended use." This indicates the algorithm's performance (i.e., the software's ability to process and display data) was tested independently. The software interfaces with hardware devices that generate the raw data, but its own function of processing and presenting that data was evaluated as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the validation of ComPAS2 v2022.1.0 was primarily:
- Existing results from the predicate device (ComPAS2 v2019.1.0): The new software's outputs were compared against the established, cleared performance of the previous version.
- Current standards for Lung Function Testing: Compliance with standards issued by the American Thoracic Society (ATS) and European Respiratory Society (ERS) (e.g., Laszlo, 2006; Macintyre et al., 2005; Miller, Crapo, Hankinson, et al., 2005; Pellegrino, et al., 2005; Wanger et al., 2005; ERS/ATS 2017 & 2019 standards).
8. The Sample Size for the Training Set
Not applicable. This is a software update to an existing device, and the testing described is primarily verification and validation against established standards and the predicate's performance. There is no mention of a machine learning or AI component requiring a "training set" in the context of this submission. The software performs calculations and displays data based on established algorithms in pulmonary function testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning or AI.
§ 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).