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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:

Note: The document explicitly states "Substantially equivalent as the subject device is compliant to the requirements of American Thoracic Society (ATS) Standardization of Spirometry 2019 update and ISO 26782: 2009" for Volume range and accuracy, and "Substantially equivalent as the subject device is compliant to the requirements of ISO 23747:2015" for Flow range and accuracy. This indicates that compliance with these standards (which contain the acceptance criteria) is the basis for demonstrating performance.

Study Details Proving Device Meets Acceptance Criteria

The provided text does not describe a specific clinical study or an AI/ML specific performance study with test sets, ground truth establishment, expert adjudication, or MRMC studies. Instead, it relies on demonstrating compliance with recognized standards.

Here's an attempt to address your points based on the available information, noting when information is not provided or not applicable to this type of device/submission:

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

   • See the table above. The acceptance criteria are inferred from the standards the device claims to meet (ISO 26782, ISO 23747, ATS/ERS 2019), and the reported performance is directly stated in the "Technical Specifications" comparison table.

2. Sample sizes used for the test set and the data provenance:

   • Not provided. The document refers to compliance with performance standards, which typically involve testing with calibrated flow/volume simulators, not necessarily a "test set" of patient data in the AI/ML context. If simulated data was used for testing against standards, its provenance isn't specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. For spirometers, "ground truth" for performance testing is established using highly accurate, calibrated flow and volume sources that can deliver specific waveforms and volumes according to the standards (e.g., defined by ATS/ERS or ISO). It's not typically established by human experts in the same way as an imaging AI device.

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

   • Not applicable. This method is characteristic of studies involving human interpretation or annotation of data, which is not the primary method for demonstrating performance of a spirometer. Performance is verified against calibrated instruments.

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 was not done. The alveoair Digital Spirometer is a diagnostic spirometer, not an AI-assisted diagnostic tool for human interpretation. Its function is to measure lung function parameters, which are then used by healthcare professionals. No "AI assistance" to human readers is mentioned or implied.

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

   • Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs the measurements digitally. However, its performance is evaluated against the technical requirements of spirometry standards, not as an AI algorithm that makes diagnostic predictions without human oversight. The device calculates parameters (FVC, FEV1, etc.) as per ATS/ERS guidelines. This is the "algorithm only" performance for a spirometer.

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

   • Calibrated mechanical/electronic simulators. For spirometers, the ground truth for performance testing is established by highly accurate, traceable calibration equipment that precisely controls and measures airflow and volume according to defined waveforms (e.g., those specified in ISO 26782 or ATS/ERS guidelines).

8. The sample size for the training set:

   • Not applicable/Not provided. This is relevant for AI/ML device development. This spirometer, based on the description, operates on an infrared interruption principle to measure physical parameters and applies direct calculations based on established physiological formulas (like those in ATS/ERS guidelines). It's not described as an AI/ML algorithm that requires a "training set" in the conventional sense.

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

   • Not applicable. As no training set for an AI/ML algorithm is described, this question is not relevant. The "ground truth" for the device's internal calculations is embedded in the standardized physiological equations and the accuracy of its physical sensors compared to calibrated references.

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