(126 days)
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.
The Vitalograph Spirotrac Model 7000 provides a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject.
Spirotrac integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.
Its primary functions are:
Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and its subdivisions. The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc.), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift).
Record subject demographic data as input.
Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database.
Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to function as a spirometer or connect to compatible devices to acquire, view, store, and print device output. It is designed for use on adults and pediatrics (5 years and older) in professional healthcare settings.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly list acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Performance testing demonstrated that the subject device met its acceptance criteria" and details the standards and guidance documents followed. The acceptance criteria can be inferred from the compliance with these standards and regulatory guidance.
The device's performance is reported as meeting the requirements of:
- ATS/ERS (2005) waveform simulator testing
- ISO 23747:2015 - Anaesthetic and respiratory equipment -- Peak expiratory flow meters
- ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans.
Inferred Acceptance Criteria & Reported Performance:
| Acceptance Criteria Category | Target / Standard (Inferred) | Reported Device Performance |
|---|---|---|
| Spirometry Measurement Accuracy & Performance | Compliance with ATS/ERS (2005) waveform simulator testing standards for spirometry parameters (e.g., FVC, PEF, FEFx, VC, FIVC, etc.). | |
| Compliance with ISO 23747:2015 for Peak Expiratory Flow (PEF) measurements. | ||
| Compliance with ISO 26782:2009 for spirometers measuring time forced expired volumes. | ||
| Data displayed and limits set (user or default) must align with these performance standards. | "Performance testing demonstrated that the subject device met its acceptance criteria." | |
| "Note that this testing was performed to demonstrate that the data displayed along with any limits set by user or by default, are aligned with these performance standards." | ||
| The device performs spirometry measurements using single breath and multiple-breath techniques, and displays/records measured lung volumes and flow rates. | ||
| Software Verification & Validation (V&V) | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005" and "General Principles of Software Validation Guidance. January 2020." | "Verification and Validation was performed following Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 and General Principles of Software Validation Guidance. January 2020." |
| Interoperability & Data Handling (acquiring, viewing, storing, printing data from compatible Vitalograph or third-party devices, subject demographic data, network operation, data import/export, email export, database management) | Functionality as described in the device description and comparison table, maintaining compatibility and data integrity. | Demonstrated through "Same" comparisons with the predicate device across various functionalities (e.g., ECG waveforms, ABPM, Spot Oximetry, Subject Management, Report Printing, Trending Graphs, Predicted Value Equations, Population Group Management, Data Import/Export, Database Management). |
| Operating System Compatibility | Support for Windows 7, 8, and 10. | Supports Windows 7, 8, and 10. |
| Patient Population | Adults and pediatrics 5 years and older. | Designed for use on adults and pediatrics, 5 years and older. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing involving waveform simulator testing (ATS/ERS) and compliance with ISO standards (ISO 23747, ISO 26782). These are typically bench tests using standardized simulated waveforms, not patient data. Therefore, there is no sample size of human subjects mentioned for the test set, nor is there information on data provenance (country, retrospective/prospective), as the testing appears to be entirely technical/engineering in nature (software V&V, bench testing against standards).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since the testing involved bench testing against international standards and simulated waveforms, there were no human experts establishing ground truth in the typical sense of clinical interpretation. The "ground truth" for these tests is implicitly defined by the parameters and specifications of the ATS/ERS and ISO standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As the testing was non-clinical and involved compliance with technical standards and simulated waveforms, there was no adjudication method described or likely needed for human discrepancies. The performance was measured against predefined technical specifications.
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. The device is a diagnostic spirometer software, not an AI-assisted diagnostic tool that aids human readers in interpreting complex images or data. Its primary function is to acquire, display, store, and print spirometry data, and interface with existing medical devices. The document does not suggest any AI components that perform diagnostic interpretation requiring human-in-the-loop studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire performance evaluation described is essentially a standalone (algorithm/software only) assessment against technical standards and simulator outputs. The V&V of the software itself and its ability to process and display data in compliance with ATS/ERS and ISO standards represents its "standalone performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the performance testing was based on international technical standards and simulated waveforms:
- ATS/ERS (2005) waveform simulator
- ISO 23747:2015 specifications
- ISO 26782:2009 specifications
These standards define the expected correct output for various spirometry maneuvers and parameters.
8. The sample size for the training set
This device did not undergo a training phase in the context of machine learning or AI. It is a software application whose functionality is based on established algorithms for spirometry and data management. Therefore, there is no training set sample size described.
9. How the ground truth for the training set was established
As there was no training set in the context of machine learning, there is no information on how ground truth for a training set was established. The software's "knowledge" or "rules" are based on the implementation of well-established medical and engineering principles for spirometry and data processing, not on learning from a labeled dataset.
§ 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).