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The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.

The SpiroScout is an electronic measurement device intended to be used for measurement of lung function (determination of the respiratory flows and volume) parameters. It enables the determination of the following parameters.
Spirometry
Inspiratory and expiratory vital capacity (VC) Inspiratory and expiratory subdivisions
Flow/Volume
The measurement of the flow/volume curve enables the determination of the dynamic lung volumes. FEV1 value (forced expiratory volume within the first second of exhalation).
Maximum Voluntary Ventilation MVV
The respiratory limit value indicates the respired volume per minute during maximally forced respiration. The respiratory limit value is also referred to as "Maximum Voluntary Ventilation".
The SpiroScout sensor operates using two diagonally opposing ultrasound transducers that alternately send and receive ultrasonic waves. The ultrasound technology simultaneously measures the flow, temperature and humidity.
The SpiroScout is a PC-based system running the Ganshorn LFX software program. The system comprises:

• the hand-held ScoutSensor
• Base station where the sensor is stored.
• Spirette, a single use, disposable mouthpiece and flow tube

The provided text lacks a detailed study description with acceptance criteria and reported device performance. It primarily focuses on the device's substantial equivalence to a predicate device for regulatory approval. However, certain performance specifications and adherence to standards are mentioned, which can be interpreted as acceptance criteria.

Here's an attempt to extract and present the information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the technical specifications provided for the proposed device (Ganshorn SpiroScout) and are implicitly considered acceptable due to its substantial equivalence claim to the predicate device.

Notes on the Table:

• Acceptance Criteria Derivation: The "Acceptance Criteria" column is largely inferred from the predicate device's specifications, as the submission claims "substantial equivalence" to the predicate. The text states: "Performance and Specifications -As above the performance and specifications are substantially equivalent to the predicate." For standards compliance, the acceptance criterion is simply compliance with the named standard.
• "Reported Device Performance": This refers to the specifications listed for the proposed device, the "Ganshorn SpiroScout."

2. Sample size used for the test set and the data provenance

The document explicitly states "No clinical testing was performed" and "No animal testing was performed." Therefore, there is no test set of patient or animal data used in a clinical study for performance evaluation that can be described. The performance data presented (e.g., flow and volume accuracy) appears to be from non-clinical, likely bench or engineering, testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical testing was performed, and therefore, no expert ground truth was established for a clinical test set. The accuracy and performance metrics are based on non-clinical engineering testing against established standards and specifications, not expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable, as no clinical testing was performed requiring adjudication of results from a test set.

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

Not applicable. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in interpretation.

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

Yes, the performance listed in the table (flow accuracy, volume accuracy, etc.) represents the standalone performance of the device (SpiroScout) based on non-clinical testing. The text describes it as an "electronic measurement device intended to be used for measurement of lung function." The approval is based on its direct measurement capabilities, not an algorithm's interpretation of findings that would require human-in-the-loop consideration.

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

For the non-clinical performance evaluation, the "ground truth" would have been established by reference standards or calibrated instruments used to measure flow, volume, and other parameters according to the requirements of the ATS (2005) standards and the device's technical specifications. These are laboratory-based, objective measurements, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is a measurement device, not a machine learning or AI model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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