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NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older.

It can be used in hospitals, in the clinical setting, and at home.

The Air Next is not intended for use in an operating room.

The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

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 75g and it is powered by 2 AAA alkaline 1.5V batteries. It 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 provided text describes the 510(k) premarket notification for the "Air Next" diagnostic spirometer. While it extensively details the device's characteristics, comparison to a predicate device, and compliance with various standards (electrical safety, EMC, usability, biocompatibility), it does not contain a specific section detailing acceptance criteria for performance, nor a study report proving the device meets these criteria with quantitative results from a test set.

The document states that the device "Meets ATS accuracy requirements" and "Air Next complies with the currently recognized safety and EMC standards," but it does not provide the measured performance data or the specific acceptance criteria in a quantifiable table as requested.

However, based on the information provided, we can infer some criteria and the general approach:

Inferred Acceptance Criteria based on Comparison to Predicate and Standards:

The document repeatedly references compliance with ISO 26782:2009 for spirometers and the Standardization of Spirometry 2019 Update (ATS/ERS guidelines). These standards and guidelines define accuracy requirements for spirometry parameters.

From the "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE" table, we can infer the acceptance criteria are likely to match or exceed the predicate device's performance and meet the relevant standards for the following parameters:

• Volume accuracy: ±3% of reading or ±0.050 L, whichever is greater
• Flow accuracy: ±5% or 200 mL/s (likely for PEF)
• Flow resistance:

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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.

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