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The alveoair Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged ≥ 22 years by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer is not intended for use during patient transport.

The alveoair Digital Spirometer is used to test lung function in people of all ages ≥ 22 years. It is intended to be used by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer was designed, developed, and manufactured at Roundworks Technologies Pvt Ltd. The model number is indicated below: ALV002 alveoair Digital Spirometer Digital Spirometer to measure lung function parameters. The alveoair Digital Spirometer system includes: alveoair Digital Spirometer, alveoMD mobile application, alveofit API Cloud server backend. The alveoair Digital Spirometer is intended to be used and compatible only with the flowMIR disposable turbine and cardboard mouthpiece manufactured by the Medical International Research s.r.l. The accessories are 510k cleared under K061712 and it is single-use disposable. Roundworks Technologies Pvt Ltd recommends the user to purchase the sinqle-use disposable flowMIR turbine on their own. One sample piece of the flowMIR (Ref. code: 910004) disposable turbine sensor and disposable cardboard mouthpiece is provided in the packaging. Roundworks recommends that the user purchase the same model turbine and mouthpiece from Medical International Research s.r.l. for further use. The alveoair digital spirometer is available in two different colors. The internal components, software, and function remain the same for both devices. The only difference is the color of the case; one is completely black and the other is a combination of black and white. The alveoair Digital Spirometer is used in combination with a turbine and mouthpiece. It utilizes a smartphone with a dedicated mobile application (alveoMD) and a cloud server (alveoFit) to view and store spirometer readings. This portable spirometer operates on the principle of infrared interruption. To perform a test, the user inhales and exhales air through the mouthpiece, which then flows into the turbine. The turbine's propeller rotates in both clockwise and counterclockwise directions, depending on the airflow. The firmware within the device calculates a series of volume and flow coordinates, in liters with respect to time in seconds, every time an interrupt data is received from the IR sensor. This process continues for 20 seconds or until the flow change calculated is less than 0.025 liters per second. When the patient inhales/exhales air into the spirometer during the standard or full loop tests. Once the test is completed, all coordinates are transferred to the mobile application using BLE. From there, the data is uploaded to the alveofit API Cloud server via the internet. For the alveoMD app, an internet connection is required to initiate the spirometry test. The alveoFit cloud server takes in the coordinates to calculate all lung parameters. Once the process is completed, a test report will be generated and displayed in the alveoMD mobile application. The internal program performs all calculations for measurements to meet ATS/ERS guideline standardization of spirometry 2019.

The provided text does not contain detailed information about specific acceptance criteria for the alveoair Digital Spirometer's performance or a study proving that the device meets these criteria in the way typically found for AI/ML-based medical devices (e.g., sensitivity, specificity, or performance against human readers).

The document focuses on demonstrating substantial equivalence to a predicate device (Air Next, K183089) and a reference device (Spirobank G, K072979) primarily through comparison of technical specifications, intended use, and adherence to relevant medical device standards.

However, based on the information provided, I can infer some aspects of what would constitute "acceptance criteria" for a spirometer and what studies were referenced to show compliance.

Here's an analysis based on the provided text, addressing the points where information is available or can be reasonably inferred within the context of a spirometer's regulatory submission:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria for the alveoair Digital Spirometer are primarily derived from the industry standards it claims to comply with, particularly ISO 26782:2009 for spirometers and ISO 23747:2015 for peak expiratory flow meters, as well as the ATS/ERS 2019 guidelines. These standards define the required accuracy and precision for spirometry measurements.

Table of Acceptance Criteria (Inferred from Standards Compliance) and Reported Device Performance:

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