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The KoKo LEGEND is intended to be used for diagnostic use in the pulmonary function testing (PFT) with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The KoKo LEGEND is indicated for use in: pulmonary function testing.

The KoKo LEGEND (Diagnostic Spirometer) is an Office Spirometer. It is intended as a configurable, portable, noninvasive pulmonary function tester (PFT) system. These tests are suitable for both pediatric and adult patient testing.

The KoKo LEGEND is a configurable, non-invasive pulmonary function tester (PFT) testing system. It is a diagnostic spirometer.

The provided text is a 510(k) summary for the KoKo LEGEND Diagnostic Spirometer and does not contain detailed information about a specific study testing the device's performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

Instead, it declares conformity to recognized standards and lists technical specifications, which implicitly serve as acceptance criteria for a diagnostic spirometer.

Here's an analysis based on the information available:

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

For a diagnostic spirometer, the "acceptance criteria" are primarily established by recognized performance standards. The device's "reported performance" is its technical specifications, which are implicitly stated to meet these standards.

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 document primarily focuses on technical specifications and conformity to established performance standards for spirometers, rather than a clinical study involving a "test set" of patients or data. The testing mentioned (e.g., "as tested with KoKo Moe filter") indicates laboratory-based performance testing rather than patient-based data.

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 not provided. As explained above, this 510(k) summary describes a diagnostic spirometer, which directly measures physiological parameters. The "ground truth" for a spirometer's measurements is the physical accuracy and reproducibility of its readings against known standards (e.g., a 3-liter syringe for volume, controlled flow rates). It does not involve expert interpretation of images or complex data where "ground truth" is established by multiple human experts.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers interpret data, and their interpretations are compared to a consensus or gold standard. For a spirometer's technical validation, the "adjudication" is against metrological standards and physical measurements.

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

An MRMC study is not applicable and not mentioned. This device is a diagnostic spirometer, which performs direct measurements. It does not incorporate AI for interpretation that would require human-in-the-loop performance improvement studies.

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

This information is not applicable in the context of an algorithm's standalone performance. The device itself is a "standalone" diagnostic instrument in that its measurements are directly generated by the device. The reported performance metrics (accuracy, resistance, etc.) are its "standalone" performance against physical standards.

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

The "ground truth" for verifying the KoKo LEGEND's performance is based on metrological standards and physical measurements. Specifically:

• Known volume standards: A 3-liter calibration syringe is explicitly mentioned for calibration, implying its use for validating volume measurements.
• Controlled flow/resistance measurements: The "as tested with KoKo Moe filter" for resistance indicates the use of a known resistance standard.
• ATS (American Thoracic Society) Standardization of Spirometry 1994 Update: This standard defines the acceptable ranges and methodologies for accurate spirometry, serving as the ultimate ground truth for the device's technical performance.

8. The sample size for the training set

This information is not provided and not applicable for this type of device. As a diagnostic spirometer without AI or machine learning components mentioned, there is no "training set" in the context of algorithm development.

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

This information is not provided and not applicable for this type of device. There is no concept of a "training set" ground truth for a physical diagnostic instrument like a spirometer.

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