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The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occupationalmedicine practitioners in lung-function diagnosis.

The Flowhandy ZAN100 USB is a pneumotachometer spirometry system. The system comprises a Windows personal computer (sold separately) for data collection, analysis, storage, and display; proprietary Betterflow ZAN100 USB software program for the PC; and a Flowlandy, hand-held pneumotach with reusable variable-orifice core, differential pneumatic pressure sensor, and USB interface. An optional computer-controlled shutter may be added to the air passageway to interrupt flow to allow pressure measurements using the on-board pressure sensor.

The ZAN100 measures the pressure drop across the known orifice to indicate the rate of breath flow both in and out of the air passageway. Knowing the flow rate of air from a subject allows the calculation of the most recognized spirometric values for the subject. Closing off the passageway with the optional shutter enables the pressure sensor to take important pressure measurements for the subject's breathing as well.

Here's an analysis of the provided 510(k) summary regarding the Flowhandy ZAN100 USB, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary only explicitly mentions meeting American Thoracic Society (ATS) requirements. While specific numerical acceptance criteria for each measurement are not detailed, the summary states that performance met or exceeded these requirements.

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

The document does not specify the sample size used for the effectiveness testing.

The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It only mentions "in-house and third-party testing."

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

The 510(k) summary does not provide any information about the number or qualifications of experts used to establish ground truth for the effectiveness testing.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for establishing ground truth for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not performed or reported. The device is a spirometer, which typically performs direct physiological measurements rather than diagnostic interpretations from images, making MRMC studies less relevant in this context. The study focuses on the accuracy and precision of the measurement itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the effectiveness testing reported is a standalone performance evaluation of the device's ability to accurately measure spirometric values. The "in-house and third-party testing" assesses the device's intrinsic measurement capabilities against established standards (ATS requirements). There is no "human-in-the-loop" aspect being evaluated in this context.

7. The Type of Ground Truth Used

The ground truth used for effectiveness testing was based on American Thoracic Society (ATS) requirements. This implies comparison of the device's measurements against accepted standards for spirometry performance, likely using calibrated flow/volume generators or established physiological models.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set or any machine learning approach that would require one. The device is a direct measurement instrument (pneumotachometer) that uses established physical principles rather than learning from a dataset.

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

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable. The device's operation is based on its physical design and calibration against known standards.

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