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Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

Aluna 2 consists of three main components:

• A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth.
• A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume.
• An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.

The provided text is a 510(k) summary for the medical device Aluna 2, a peak flow meter for spirometry. It compares the Aluna 2 to its predicate device, the original Aluna, and details the non-clinical testing performed to establish substantial equivalence.

However, the document explicitly states: "Clinical testing was not required." This means there was no clinical study conducted involving human subjects to directly prove the device meets acceptance criteria for improved human reader performance with AI assistance, or standalone performance against clinical ground truth.

Therefore, many of the requested points regarding acceptance criteria and study design for clinical or AI-driven performance cannot be answered from the provided text, as this type of study was not performed. The device's substantial equivalence was demonstrated through non-clinical bench testing and adherence to standards for accuracy, safety, and software.

Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, focusing on the technical specifications and non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The acceptance criteria are derived from the specified accuracy, linearity, repeatability, and impedance/resistance limits required by the "2019 ATS Update v. 2005 ATS Guidelines" and ISO standards. The reported device performance is implicitly demonstrated by the statement: "The results of these tests indicate that Aluna 2 is substantially equivalent to the predicate device." and the fact that it tightened some specifications compared to the predicate.

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