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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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The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices.

Comarch e-Care Platform displays the collected measurements on the Web application and securely stores them in a database server, where the caregiver can view them, leave comments and contact patient if necessary. Caregivers are able to set thresholds individually for each patient. Measurement results sent to e-Care Platform from connected devices are analyzed and if result is beyond the threshold, caregiver gets the notification.

The Comarch e-Care Platform is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

The Comarch e-Care Platform is contraindicated for patients requiring direct - medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Comarch e-Care Platform is a software intended for use in remote patient monitoring outside of traditional healthcare settings (e.g. at home). Components of Comarch e-Care Platform are: Comarch SMA application, Comarch e-Care application, application server, database server.

Comarch SMA is a software application intended to use by patients. It is designed to collect, display and transmit vital sign measurements captured from commercially available home monitoring devices.

The following vital signs are collected: temperature, glucose, noninvasive blood pressure, pulse oximetry, weight and spirometry.

The Comarch e-Care Platform is a software intended for use in remote patient monitoring outside of traditional healthcare settings (e.g. at home). It connects with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers, glucometers) and sends the measurement results to a central server. The platform displays collected measurements on a web application, securely stores them, and allows caregivers to view and analyze them, leave comments, and contact patients. Caregivers can set individual thresholds for each patient, and the platform notifies the caregiver if a measurement result is beyond the set threshold. The device is not interpretive, not intended for diagnosis or as a substitute for medical care, and does not provide real-time data. It is for patients who are able and willing to manage its use, and clinical judgment by a caregiver is required to interpret the information.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, the substantial equivalence determination for the Comarch e-Care Platform is based on similarities to predicate devices in terms of:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that "no clinical tests were conducted." Therefore, there is no specific test set or data provenance mentioned for clinical performance evaluation. The evaluation was based on non-clinical verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical tests were conducted and no specific test set-based ground truth was established, this information is not applicable and not provided in the document.

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

Since no clinical tests were conducted and no test set ground truth was established by experts, this information is not applicable and not provided.

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

The document explicitly states "no clinical tests were conducted." Therefore, no MRMC comparative effectiveness study was done, and no effect size regarding human reader improvement with/without AI assistance is provided.

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

The substantial equivalence is based on the device's functional similarities to predicate devices in remote patient monitoring, data transmission, storage, and caregiver notification, rather than a standalone performance evaluation of a diagnostic algorithm. The device itself is described as "not interpretive" and "not intended for diagnosis." The non-clinical verification and validation focused on the software's functionality and adherence to design specifications. Therefore, a standalone performance study in the context of diagnostic accuracy was not performed for this device.

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

As no clinical tests were performed, there was no "ground truth" derived from patient data, expert consensus, pathology, or outcomes data for the purpose of validating diagnostic or interpretive accuracy. The "ground truth" for the non-clinical verification and validation would have been the design specifications and requirements of the software.

8. The sample size for the training set

The document states "no clinical tests were conducted." This implies that the device did not undergo a process involving a "training set" for machine learning model development in the context of clinical performance. The platform's functionality is about data handling and alerts based on pre-set thresholds, not on learning from a dataset to perform interpretations. Therefore, this information is not applicable and not provided.

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

As no training set was used for clinical performance evaluation, this information is not applicable and not provided.

In summary, the Comarch e-Care Platform's acceptance was based on a demonstration of substantial equivalence to existing predicate devices through comprehensive non-clinical verification and validation testing, ensuring the software's functionality, adherence to design specifications, and addressing identified risks. No clinical studies or performance evaluations requiring test sets, ground truth establishment, or expert adjudication were conducted, as the device is not interpretive and does not provide diagnostic insights.

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