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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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