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The Minispir and 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.

Minispir is a spirometer and pulse oximeter (optional) connected to a Personal Computer using a USB cable. The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart pulse rate.

The provided text describes a 510(k) premarket notification for the Minispir device, which functions as both a spirometer and a pulse oximeter. The submission aims to demonstrate substantial equivalence to a predicate device (Minispir, K082766).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to industry standards as acceptance criteria rather than explicitly listing them.

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

• Spirometry: No specific sample size for a test set is mentioned. The document states "Spirometry testing was performed according with American Thoracic Society (ATS) Standards." This implies a set of tests conforming to ATS guidelines, but the number of subjects or tests is not provided.
• Oximetry: A "clinical investigation" was carried out for oximetry, but no sample size for this investigation is provided.
• Data Provenance: Not explicitly stated, but given the applicant is "MIR Medical International Research" located in "Roma - Italy," it is reasonable to infer the studies might have been conducted in Italy or other European locations. The document does not specify if the data was retrospective or prospective.

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

• The document does not mention the use of experts or a ground truth established by experts for either spirometry or oximetry testing.
• For spirometry, the ground truth is implicitly defined by the ATS Standards, which govern the expected physical characteristics and accuracy of the device.
• For oximetry, the "clinical investigation" validated the accuracy, but the method for establishing the true oxygen saturation for comparison (the "ground truth") is not detailed. Typically, this would involve a co-oximeter or arterial blood gas analysis, but this is not stated.

4. Adjudication Method:

• Not applicable/Not mentioned. The testing described for spirometry and oximetry appears to be direct device performance measurement against a standard or a reference, rather than a subjective assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study typically assesses the improvement in human reader performance (e.g., radiologists interpreting images) with AI assistance. The Minispir is a diagnostic device for measuring physiological parameters, not an AI-powered image interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the studies described are essentially standalone performance evaluations.
  • Spirometry: The device's spirometry function was tested against ATS standards, meaning the algorithm's measurements were compared to the accuracy requirements.
  • Oximetry: A "clinical investigation... to validate the new oximetry board" also implies evaluation of the device's output (SpO2, pulse rate) directly against a reference, without human intervention in the measurement process itself, although a human operates the device.

7. Type of Ground Truth Used:

• Spirometry: Indirectly, the "ground truth" is derived from the American Thoracic Society (ATS) Standards. These standards define the expected accuracy and performance range for spirometers, so the device's measurements are compared against these established technical and physiological benchmarks rather than individual patient-specific "ground truth" established by an expert or pathology.
• Oximetry: For the clinical investigation, the ground truth for oximetry (SpO2 and pulse rate) would typically be established by a reference method such as an arterial blood gas analyzer or a co-oximeter. However, the document only states that "results demonstrated required accuracy" without specifying the reference method used to establish this truth.

8. Sample Size for the Training Set:

• The document does not provide any information about a training set. This is consistent with the nature of the device, which relies on established physiological measurement principles and algorithms rather than machine learning models that require training data. The algorithms for spirometry and oximetry are stated to be the "same algorithms" as the predicate device, implying they are well-established.

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

• Not applicable, as no training set is mentioned or implied for a device of this nature.

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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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The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter 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 Spirolab III with its integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Spirolab III calculates several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.

Acceptance Criteria and Study for MIR Minispir - Spirolab III

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size for the "test set" used for spirometry or oximetry performance evaluation. It generally states that "testing was done."

The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The document refers to compliance with "American Thoracic Society (ATS) Standards" for spirometry, implying a recognized standard as the benchmark rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

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

No, an MRMC comparative effectiveness study is not mentioned. The study focuses on demonstrating that the device meets established technical standards (ATS) and safety regulations, rather than comparing its performance against humans or human performance with/without AI assistance.

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

Yes, the testing described appears to be a standalone performance evaluation. The device's spirometry function was tested "according with American Thoracic Society (ATS) Standards," which implies an assessment of the device's accuracy in measuring and calculating spirometric parameters. The safety and environmental testing also pertains to the standalone device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For spirometry, the ground truth was based on the American Thoracic Society (ATS) Standards. This implies an objective, standardized set of criteria and acceptable ranges for spirometric measurements and calculations.

For safety and environmental testing, the ground truth was compliance with EN 60601-1:1990 and EN 60601-1-2:1993 (safety and EMC standards) and the device's own specifications.

8. The Sample Size for the Training Set

The document does not mention a training set. This is not an AI/ML device in the modern sense that would typically involve a "training set" for model development. The algorithms for spirometry and oximetry calculation are stated to be the same as the predicate devices, suggesting pre-existing, validated algorithms rather than newly trained ones.

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

As no training set is mentioned in the context of this device, this question is not applicable. The device relies on established algorithms and compliance with regulatory standards.

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