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The Resmon PRO FULL is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Resmon PRO FULL is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics. and private physician offices.

Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT).

FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system.

FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device.

Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.

The provided text describes the regulatory clearance of the Resmon PRO FULL device. However, it does not include detailed information regarding specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) or a study that rigorously proves the device meets these criteria in the typical sense of a clinical performance study for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Carefusion MasterScreen IOS K101873) through technological comparison and non-clinical performance testing. The "performance testing" described is primarily about reproducibility, repeatability, and a comparative analysis of measured parameters against the predicate, rather than a clinical effectiveness study.

Based on the provided text, here's what can be extracted and what is missing:

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

The document does not state explicit acceptance criteria in the form of thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device. The performance is assessed through reproducibility, repeatability, and comparison of measured parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Comparative testing was done with the subject device and the predicate across the range of parameters and performance specifications."

• Sample Size: Not specified. It only mentions "Multiple units were tested" for reproducibility/repeatability. There is no information on the number of subjects or types of data used for the comparative testing with the predicate.
• Data Provenance: Not specified (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a measurement device for physiological parameters (respiratory impedance). Its performance is evaluated against physical standards and comparison with another device, not against expert-labeled ground truth for diagnosis/interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no expert adjudication mentioned or required for this type of device evaluation.

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

No. This device is a diagnostic spirometer using the Forced Oscillation Technique (FOT) to measure respiratory impedance. It is not an AI-assisted diagnostic imaging device or an AI application with a "human-in-the-loop" for interpretation that would typically undergo an MRMC study. It is stated that "The device is not intended to be used as a stand-alone diagnostic device."

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

Yes, in a sense. The performance tests ("Hardware Verification," "Software and System Verification and Validation," "Reproducibility and Repeatability," "Comparative testing") evaluate the device's ability to accurately measure and report physiological parameters according to its specifications and in comparison to a predicate device. This is the "standalone" performance of the measurement system itself. There are no algorithms described beyond the calculation of respiratory impedance from pressure and airflow.

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

The "ground truth" for this device's performance evaluation would be:

• Physical calibration standards/simulators: Used to verify accuracy, resolution, and range of flow, pressure, and volume measurements.
• Predicate device measurements: For comparative testing, the predicate's measurements serve as a reference point for demonstrating statistical equivalence in measured parameters.
• Established scientific principles: The device's operation based on the Forced Oscillation Technique (FOT) adheres to these principles.

8. The sample size for the training set

Not applicable. This document does not describe the development of an AI/ML algorithm that requires a training set. The device appears to be a hardware-based measurement system with embedded software for calculations, not a learnable model.

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

Not applicable (as above).

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