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The MIR Minispir - Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician.

The devices are intended to test lung function and can make:

• spirometry testing in people of all ages, excluding infants and neonates.
• oximetry testing in people of all ages.

They can be used in any setting.

MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Minispir - Spirolab III with their integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Minispir - Spirolab III calculate several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.

The provided 510(k) summary for the MIR Minispir - Spirolab III describes performance testing related to safety, environmental factors, spirometry accuracy, and oximetry accuracy. However, it does not present acceptance criteria and performance in the format of a table with specific quantitative metrics. The summary focuses on equivalence to a predicate device and adherence to general standards rather than detailed acceptance criteria for specific clinical performance.

Here's a breakdown of the available information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria and corresponding device performance metrics for diagnostic accuracy. Instead, it states qualitative outcomes:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified, but the testing was "in-house" for oximetry and generally refers to compliance with international standards (ATS, EN 60601-1) rather than a specific clinical test set from a particular country or population. The document is for an Italian company, so it's likely the testing occurred in Italy or by a third-party laboratory. The studies are described as verification and validation of compliance, not a clinical trial with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The testing described for spirometry and oximetry appears to be technical validation against standards and simulators, not a clinical study involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are technical compliance checks against established standards or simulator outputs, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned or described in the summary. The submission focuses on substantial equivalence based on technical characteristics and compliance with performance standards, not on demonstrating improved human reader performance with AI assistance. The device itself is a measurement tool (spirometer and oximeter), not an AI-powered diagnostic tool for interpretation.

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

The device's core function is to directly measure and calculate spirometric and oximetric parameters. The performance described—spirometry calculations per ATS standards and oximetry accuracy verified with an optical simulator—is essentially "standalone" algorithm performance in terms of its ability to accurately measure and process physiological data. There isn't a human-in-the-loop component for the device's output itself; the device provides raw measurements and calculated parameters for a clinician to interpret.

7. The Type of Ground Truth Used

• Spirometry: The "ground truth" implicitly refers to the accuracy requirements and established norms of the American Thoracic Society (ATS) Standards. This suggests a comparison against known, calibrated inputs or reference methods defined by ATS.
• Oximetry: The "ground truth" was established "in-house using an optical simulator." This indicates a controlled, simulated environment where the expected SpO2 and pulse rate values are known and used to test the device's accuracy.

8. The Sample Size for the Training Set

Not applicable. This device is a measurement instrument with established algorithms based on physiological principles related to spirometry and oximetry, not a machine learning model that requires a "training set" in the conventional AI sense. The algorithms are static and pre-defined based on physics and physiology.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device. The algorithms are based on established scientific principles rather than machine learning from data.

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