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SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.

It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical, and hospital settings.

The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The proposed device consists of a compact main unit and an ultrasonic flowmeter sensor used with a pulmonary function filter. The device uses an ultrasonic sensor that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.

The provided document is a 510(k) premarket notification for the SpiroThor spirometer, asserting its substantial equivalence to a predicate device, the SDI AstraSonic Spirometer (K092813).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the SpiroThor is identical to the predicate device, the SDI AstraSonic Spirometer (K092813), with minor differences being a name change and the use of a different bacterial filter which was shown through comparative testing to have no performance differences. Therefore, the acceptance criteria and reported device performance are assumed to be the same as the predicate device, which are explicitly listed in Table 1 – Comparison to Predicate.

Note: The document explicitly states "The proposed SpiroThor is identical to the AstraSonic Spirometer cleared under K092813 with these differences, name change and that another cleared bacterial filter may be used with the device." and "The SpiroThor and predicate, K092813 – SDI AstraSonic Diagnostic Spirometer, are identical devices with minor differences. Namely, both products are produced by Thormed ("THOR") and the only differences are the name of the device and that another bacterial filter may be used with the proposed device."
Therefore, the reported device performance is stated to be identical to the predicate for all listed specifications.

2. Sample size used for the test set and the data provenance

The document states that "For K092813, THOR performed a number of bench tests." and lists several standards and tests. It explicitly mentions:

• American Thoracic Society (ATS) 24 standard waveforms
• ISO 26782:2009
• Accuracy of waveform generator
• Flow resistance test
• EN 60601-1:2006/AC:2010
• EN 60601-1-2:2007/AC:2010
• EN 60601-1-6:2010
• Performance to specifications with each bacterial filter

While these indicate a test set was used, the specific sample size (number of devices, number of replicates, etc.) for the test set is not provided. The data provenance is also not specified (e.g., country of origin, retrospective or prospective), but given it's bench testing, it's likely a controlled laboratory environment. The tests were performed by "THOR," the manufacturer of both the predicate and proposed device.

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

This information is not provided. The "ground truth" for the performance specifications would be established by the reference standards and calibrated equipment used in the bench tests, not by human experts interpreting results.

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

This is not applicable as the evaluation involved objective measurements against established technical standards and specifications, not subjective interpretation requiring adjudication among experts.

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 is not applicable. The device is a spirometer for basic lung function tests, which measures physiological parameters. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

A form of "standalone" evaluation was performed as the device's technical specifications and accuracy (e.g., volume accuracy, flow accuracy, dynamic resistance) were tested through bench testing against objective standards without human intervention in the measurement process itself. The document states: "The testing demonstrated that the SpiroThor performed as intended and met its performance specifications". This indicates its standalone performance.

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

The ground truth used for performance validation was based on established industry standards and physical measurements from a "waveform generator" and other calibrated laboratory equipment. Specifically, the "American Thoracic Society (ATS) 24 standard waveforms" and "ISO 26782:2009" are mentioned, which serve as the objective ground truth against which the spirometer's measurements were compared.

8. The sample size for the training set

This is not applicable. The SpiroThor is a measurement device, not an AI/ML algorithm that requires a training set. Its functionality is based on ultrasonic technology and algorithms for flow measurement, which are deterministic rather than learned from data.

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

This is not applicable as there is no training set for this type of device.

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