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Air Next is intended to be used by:

Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and > 110 cm.

Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.

Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis.

Air Next is a hand-held spirometer, weighing only 75g and it is powered by 2 AAA alkaline 1.5V batteries. lt consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores. The package includes one Air Next device, one NuvoAir disposable turbine through which the user can start using the Air Next, two AAA 1.5V alkaline batteries, one user manual and one cotton bag to carry the device. Dimensions of the Air Next are 98 x 62 x 26 mm, which can be seen in the engineering drawing in the attachments.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Air Next spirometer, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Air Next spirometer meets ATS/ERS 2005 guidelines and ISO standards for spirometers. The performance of the Air Next related to specific technical specifications is compared directly to the predicate device, implying these represent the acceptance criteria derived from industry standards.

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

The document does not explicitly state a sample size for the test set for the spirometry performance characteristics (volume, flow accuracy, etc.). The performance testing described primarily refers to adherence to international standards and direct comparison of specifications with a predicate device.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing appears to be primarily lab-based performance verification against established standards rather than clinical data from human subjects.

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

This information is not provided in the document. The ground truth for the device's technical performance metrics (volume, flow accuracy, etc.) is established by recognized international standards (ATS/ERS 2005, ISO 26782, ISO 23747) and likely verified using calibrated testing equipment. There's no mention of human experts defining ground truth for these quantitative measurements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since the performance testing focuses on objective technical measurements verified against standards, an adjudication method for a "test set" in this context is not applicable and not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The device is a diagnostic spirometer for basic lung function testing, not an AI-assisted diagnostic imaging device that would typically involve MRMC studies to assess human reader improvement with AI.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted. The "Performance Testing" section describes various tests against international standards (IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-2) and the ATS/ERS 2005 guidelines. It also explicitly states that the device was tested against B.T.P.S. conditions and that "results are well within range."

The technical specifications for volume and flow accuracy are presented as direct measurements or capabilities of the device itself. While there is a comparison to a predicate device, the Air Next's own performance against these metrics constitutes standalone testing.

7. Type of Ground Truth Used

The ground truth used for the device's performance is based on established international standards and guidelines for spirometry. Specifically, the ATS/ERS 2005 guideline, EN ISO 26782:2009 (Anesthetic and respiratory equipment – Spirometers), and EN ISO 23747:2015 (Peak expiratory flowmeters) are cited. These standards define the acceptable ranges and methodologies for measuring spirometry parameters accurately.

8. Sample Size for the Training Set

This document does not describe any machine learning or AI components that would require a "training set". The Air Next is a hardware device with firmware that converts rotations into airflow measurements. Therefore, a training set sample size is not applicable in the context described.

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

As there is no mention of a training set for machine learning/AI, the method for establishing its ground truth is not applicable. The device's functionality relies on physical principles and standard conversion algorithms, not learning from data.

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