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The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinical settings in occupational medicine.

The ndd EasyOne Air is a diagnostic spirometer.

In order to conduct simple diagnostic spirometry testing, the EasyOne Air is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (EasyOne Flow Tube).

The sensor is an ultrasound flow sensor that measures pulse transit-time to determine gas flow velocity and volume, as well as molar mass of the gas. The collected data is used for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.

This document describes the EasyOne Air Spirometer. However, it does not contain the specific information required to complete all parts of your request, especially regarding a clinical study with acceptance criteria and reported device performance in the format you provided. The document primarily focuses on demonstrating substantial equivalence to a predicate device for FDA 510(k) clearance.

Here's an analysis of the provided text in relation to your request:

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

The document mentions "Dynamic wave form testing and comparative testing with a commercially available ndd Spirometer confirmed that the EasyOne Air Spirometer meets the spirometry recommendations for accuracy and precision published by the American Thoracic Society (ATS)."

However, it does not provide a table of specific acceptance criteria (e.g., specific thresholds for FVC accuracy) or the numerical reported device performance in a format that could be directly extracted into such a table. It only states that the device "meets the spirometry recommendations."

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

This information is not provided in the document. The testing described is "Dynamic wave form testing and comparative testing," which implies laboratory testing and comparison against a predicate device, rather than a clinical study with human subjects whose data provenance would be relevant.

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)

This information is not applicable and therefore not provided in the document. The testing was against established spirometry recommendations and comparison to a predicate device, not against ground truth established by experts interpreting outputs from the device in a clinical context.

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

This information is not applicable and therefore not provided. No adjudication method is described because there's no expert interpretation of device outputs.

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

This information is not applicable and therefore not provided. The EasyOne Air Spirometer is a diagnostic device for measuring lung function, not an AI-powered image analysis tool that would typically involve human readers and efficacy studies like MRMC.

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

The document describes the performance of the "EasyOne Air Spirometer" itself, which is a standalone device in the context of spirometry. It measures and processes data without human input affecting the measurement itself. The results are then displayed for interpretation by healthcare professionals. So, in a sense, its primary function is "standalone" (algorithm only) in generating the spirometry measurements. However, the term "standalone performance" often refers to an AI algorithm's performance before human review in a diagnostic workflow, which isn't directly analogous here.

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

The "ground truth" for the performance claims appears to be:

• ATS (American Thoracic Society) spirometry recommendations for accuracy and precision.
• Comparison to the predicate device (ndd EasyOne Spirometer).

8. The sample size for the training set

This information is not applicable and therefore not provided. The EasyOne Air Spirometer is a measurement device, not an AI/ML model that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

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