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The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.

The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.

The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.

Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume.

Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure.

Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume.

Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor.

Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor.

The PowerCube+ Series has the following product model configurations:

• . PowerCube Body+ includes Spirometry and Body Plethysmography measurement
• . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement
• . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement

All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement.

The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.

The provided text focuses on the substantial equivalence of the GANSHORN PowerCube+ Series to predicate devices for regulatory clearance. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the format requested (i.e., a clinical study with human readers and AI).

The document outlines a series of bench tests to demonstrate performance in various modalities, but these are not structured as clinical studies with acceptance criteria for device performance parameters related to a "ground truth" established by experts in a diagnostic context. Instead, the performance testing focuses on compliance with international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines) and comparison against a calibrated flow/volume simulator or an FDA-cleared device.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance and AI integration, which are not detailed here.

However, I can provide what is available regarding performance testing and some related details:

1. A table of acceptance criteria and the reported device performance

The document mentions compliance with various standards and internal requirements, and comparative bench testing. Here's what can be extracted, focusing on quantitative performance where available:

Regarding the study that proves the device meets acceptance criteria:

The study referenced is a series of bench tests and comparative bench testing against an FDA-cleared device.

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

• Sample size for test set: Not explicitly stated in terms of number of patient cases. The "test set" for performance was described as using a "calibrated Hans-Rudolph flow/volume simulator at a range of physiological test points" and "simulated inhalation and exhalation with calibrated gas mixtures." For comparative testing with the predicate device, it mentions comparing measurements, but not a specific sample size of test points or patient data.
• Data provenance: Bench testing results and simulated data. No real-world patient data is mentioned for testing device performance against ground truth in a clinical context.

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

Not applicable. The ground truth for bench testing was established by calibrated instruments and simulators, not human experts.

4. Adjudication method for the test set

Not applicable, as ground truth was established by calibrated instruments, not human review requiring adjudication.

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. This document describes a medical device for measuring lung function parameters, not an AI-assisted diagnostic tool that involves human readers.

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

The device itself is a measurement system; its "performance" is its accuracy in providing these measurements. The document outlines standalone performance evaluations through bench testing to ensure the device accurately measures lung function parameters. There is no mention of a separate "algorithm only" performance study in the context of an AI-based diagnostic algorithm.

7. The type of ground truth used

For the performance testing, the ground truth was established by:

• Calibrated instruments and simulators (e.g., Hans-Rudolph flow/volume simulator, calibrated gas mixtures).
• Compliance with recognized international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines).
• Measurements from an FDA-cleared predicate device for comparative analysis.

8. The sample size for the training set

Not applicable. This is a medical measurement device, not an AI/machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for an AI/machine learning model mentioned.

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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.

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