(126 days)
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
The GoSpiro is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and avoids the need for individual calibration prior to performing a test.
The Monitored Therapeutics, Inc. GoSpiro® is a diagnostic spirometer intended for use by adults and children over 5 years old in physician's offices, clinics, and home settings for basic lung function and spirometry testing. It is a single-patient use device.
Here's an analysis of its acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests and compliance with established standards, but it does not explicitly list quantitative acceptance criteria for each spirometry parameter (e.g., FVC, FEV1) with specific numerical ranges. Instead, it states that "The GoSpiro passed the acceptance criteria for all the listed testing requirements and specifications." and "The performance and specifications demonstrate that the devices meet the ATS 2005 requirements for pulmonary function testing." This implies that the acceptance criteria are adherence to the ATS 2005 guidelines for spirometry, and the device met these.
However, the document does provide specific performance metrics in the comparison tables, which can be interpreted as demonstrating the device's capabilities relative to its predicates and standards.
| Acceptance Criteria (Implied by ATS 2005 and Predicate Comparison) | Reported Device Performance |
|---|---|
| Flow/Volume Accuracy | ±5% or 200 mL/s |
| Volume Accuracy | ±3% of reading, or 0.05 liters, whichever is greater |
| Flow Range | +14 l/s |
| Volume Range | 0-8 liters |
| Flow Resistance | 137 Pascals (Pa) per Liter per second, measured at 14 Liters per second (Lps) |
| Operating Conditions (Temperature) | 17 to 35°C |
| Operating Conditions (Humidity) | 30%RH to 75%RH |
| Compliance with ATS Spirometry Guidelines | Yes |
| Compliance with Safety Standards | AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Biocompatibility | Passed ISO 10993-1, including cytotoxicity, irritation, sensitization, VOC, CO, CO2, Ozone, and PM25 testing |
| Environmental Requirements | Passed |
| Modes of Operation (Functional) | Passed |
| ATS/ERS waveform simulator testing | Passed |
| High Altitude Performance | Passed |
| Possible Cough Detection (Functional) | Passed |
| Durability turbine life test | Passed |
| Mechanical Requirements | Passed |
| Electrical Requirements (Battery Safety, Wireless Coexistence, Bluetooth Module) | Passed (IEC 62133) and documented |
| PCB and Electrical Circuitry Requirements | Passed |
| Packaging and Shipping Requirements | Passed |
| Hardware Verification | Passed |
| Labeling Requirements | Passed |
| Manufacturing Requirements | Passed |
| Safety Requirements | Passed |
| Cleaning and Shelf-life | Passed |
| Software and System Verification and Validation | Passed (IEC 62304) |
| Human Factors study | Passed |
2. Sample size used for the test set and the data provenance
The document states that "ATS / ERS waveform simulator testing" was performed and passed. However, it does not specify the sample size (number of waveforms or individuals) used for this test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as this was likely a bench/simulator test rather than a clinical study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document because the testing appears to be primarily technical/bench validation against established spirometry standards (ATS/ERS waveform simulator testing) rather than a clinical study requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
An adjudication method is not applicable or not described in the provided text, as the testing was focused on the device's technical performance against a simulator and compliance with standards, not on interpreting images or clinical outcomes that would require adjudicators.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. The GoSpiro is a diagnostic spirometer that measures lung function, not an AI-powered diagnostic system requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described ("ATS / ERS waveform simulator testing") represents a standalone evaluation of the algorithm's accuracy at measuring flow, volume, and time against a known standard. Although not explicitly called an "algorithm-only" study, the nature of testing against a simulator implies measuring the device's output independently. The document states that the device performed all calculations to meet ATS/ERS requirements and included quality control measurements and indices of measurement quality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance appears to be established by ATS/ERS waveform simulator testing. This refers to a standardized set of flow-volume and volume-time curves designed to test spirometer accuracy against known, ideal physiological breathing patterns. These simulators provide a "gold standard" input against which the device's measurements are compared.
8. The sample size for the training set
This refers to a software or AI model's training data. The document does not mention a training set as the device is a hardware spirometer with embedded firmware/software for calculations, not a machine learning or AI model that undergoes a separate training phase with a distinct dataset.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI model, this information is not applicable in the provided text. The device's functionality relies on established physiological principles and engineering specifications, validated against standardized simulator inputs.
§ 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).