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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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ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including Spirometry, airway strength and output, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, training, assessment, and other related activities.

The ZAN Lung-Function Lab (LFL) is a full-featured, PC-based system for professional evaluation of pulmonary function, cardiopulmonary exercise capacity, and metabolism. A personal computer (PC) is the central component of the system, collecting data from pulmonary instruments, calculating lung-function test, stress, and training parameters, entering demographic and other subject information, and displaying/reporting the results. The system comprises Four pulmonary instruments (flow sensor with airway pressure capability, diffusion-gas analyzer, ventilation-gas analyzer, and body plethysmograph), a PC running a proprietary ZAN test program, test gases of known compositions, leads, tubes, and valves connecting the instruments and computer, and an optional cart for normalizing expansion. In addition, optional physiologic sensing equipment (including exercise electrocardiographs, pulse oximeters, etc.) may supply data to the LFL to provide expanded testing capability.

Here's a breakdown of the acceptance criteria and study information for the ZAN Lung-Function Lab, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the ZAN Lung-Function Lab primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than defining explicit acceptance criteria for specific performance metrics with target values to achieve. However, based on the text, we can infer some performance expectations and the reported compliance.

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

• Test Set Sample Size: The document does not explicitly state a specific "test set" sample size in terms of patient numbers. The effectiveness claims are based on "in-house and third-party testing" against published operating conditions and comparison to competing units/simulation systems. The clinical performance refers to "years of successful operation in Europe" but not a structured clinical study for this 510(k) submission.
• Data Provenance:
  • Effectiveness Testing: "In-house and third-party testing" (no specific country mentioned, likely Germany where the company is based, and potentially in the US for third-party). The nature of this testing (bench, in-vitro) suggests it's not patient-based in the traditional sense of a clinical trial.
  • Clinical Performance: "CE marking and years of successful operation in Europe" indicates retrospective data from real-world use in Europe.

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

The document does not describe a clinical study with human experts establishing ground truth for a test set. The performance claims are primarily based on:

• Engineering and bench testing against recognized standards.
• Comparison to predicate devices.
• Comparison to "published American Thoracic operating conditions requirements."
• "Gas exchange was tested against a simulation system."

There is no mention of a ground truth established by a panel of experts for the technical performance tests. The clinical performance statement refers to safe and effective use by "patients and clinicians" in Europe, implying general clinical acceptance rather than a specific expert-driven ground truth assessment for this submission.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no patient-based test set with ground truth established by experts that would require an adjudication method.

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

No. The document makes no mention of an MRMC study comparing human readers with and without AI assistance. The ZAN Lung-Function Lab is a diagnostic measurement device for pulmonary function, not an AI-assisted interpretation tool for images or other complex data that would typically involve an MRMC study.

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

The device itself is a measurement system that provides quantitative pulmonary function data. Its performance, as described, is inherently "standalone" in the sense that the sensors and analyzers produce the measurements. There isn't an "algorithm only" performance being evaluated separate from the physical device taking measurements, as it is a complete system. The measurements are then used by clinicians.

7. The Type of Ground Truth Used

The ground truth for the performance claims appears to be:

• For Safety and Effectiveness: Recognized international consensus standards (e.g., EN 60601-1) and "published American Thoracic operating conditions requirements," as well as "test gases of known compositions" and "simulation system" for gas exchange analysis.
• For Equivalence: The performance characteristics and technologies of the predicate devices (SensorMedics Vmax and Collins CPL).
• For Clinical Use: "Years of successful operation in Europe" implying real-world clinical outcomes and acceptance.

8. The Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/machine learning model that undergoes a "training set" for classification or prediction. Its operation is based on established physical and chemical principles and algorithms for calculating pulmonary function parameters from measured values.

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

Not applicable, as there is no "training set" in the context of machine learning. The device's underlying principles and calibration would be based on fundamental scientific understanding and established clinical standards (e.g., American Thoracic Society guidelines).

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