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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.

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.

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The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.

The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.

The MicroLab / MicroLoop is a mains/battery operated desktop spirometer. It has context sensitive help screens, accessed at the touch of a button, that explain its features and navigational aides, making it easy to use. The results may be uploaded to a PC using the optional "Spirometry PC" software and patient details may be downloaded to the MicroLab / MicroLoop. Using spirometry PC software (SPCS) and the MicroLab / MicroLoop, live blows can be performed with the PC directly controlling the operation of the MicroLab / MicroLoop. The results and graphs produced are displayed directly on the PC screen. Stored data on the devices can be printed on an external printer using the USB cable supplied or uploaded to the PC. In addition the MicroLab is able to print the data on its integral thermal printer. Optional a Nonin Ipod® SpO2 sensor can be connected to the MicroLab / MicroLoop.

The scientific concept which forms the basis of the MicroLab / MicroLoop is the CareFusion Digital Volume Transducer, a stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.

The provided document is a 510(k) Pre-market Notification for the MicroLab/MicroLoop spirometer and its optional SpO2 module. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study to prove device meets acceptance criteria through specific quantitative performance metrics beyond what's stated for regulatory compliance.

However, based on the Summary of Device Testing (Section 5.15) and the Summary Discussion of Bench Performance Data in the document, I can infer the acceptance criteria and study approach.

Key takeaway: The submission emphasizes compliance with recognized standards rather than detailing specific de novo performance studies with novel clinical endpoints or expert ground truth.

Here's the breakdown based on the information provided:

1. A table of acceptance criteria and the reported device performance

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 does not specify the sample sizes for the test sets used in the bench testing. It refers to "applicable tests and standards" and "validation and verification testing" but does not provide details on the number of subjects or samples for any specific performance measurement. The focus is on demonstrating compliance with standards rather than a clinical study with a specific patient cohort. The testing was non-clinical (bench testing) and likely conducted in Germany where the company is based.

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)

This information is not applicable and not provided. The testing described is primarily bench testing against established engineering and performance standards (e.g., ATS/ERS for spirometry, Nonin's own specifications for oximetry accuracy) and regulatory safety standards. There is no mention of human expert-derived ground truth as would be required for diagnostic image analysis or similar AI/ML-driven devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods typically relate to expert consensus on ground truth in a clinical study. The document describes non-clinical bench testing.

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 and pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers. The submission explicitly states: "Clinical testing was not performed with this device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance testing described is standalone algorithm/device performance. The device provides direct measurements (spirometry parameters, SpO2, pulse rate). The "Summary of Device Testing" (Section 5.15) and "Summary Discussion of Bench Performance Data" (Section 11) describe non-clinical bench tests confirming the device's technical performance against established standards, independent of human interpretation or assistance beyond operating the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For spirometry, the ground truth would be precise, calibrated flow and volume simulators/generators that meet the reproducibility and accuracy requirements of standards like ATS/ERS.

For oximetry, the ground truth for SpO2 and pulse rate accuracy would be from a reference oximeter or a controlled human desaturation study (though the document states "clinical testing was not performed," implying it relies on the Nonin module's pre-established accuracy or simulated scenarios). The "Accuracy Testing" for the oximetry module would compare its measurements to highly accurate reference instruments under various conditions.

In essence, the ground truth is derived from validated engineering measurement standards and reference devices.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a "training set" in the conventional sense of AI development. It's a traditional medical device based on established physical principles (digital volume transducer for spirometry, light absorption for oximetry).

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm.

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