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The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The Lung Q software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluation, fissure evaluation, and reporting tools are provided.

The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.

The provided text describes two non-clinical performance studies conducted for the LungQ software: an "Equivalence study" and "Additional performance testing of Thirona LungQ fissure analysis."

Here's a breakdown of the acceptance criteria and study details for the Equivalence Study, as it is the primary study proving the device meets general acceptance criteria by demonstrating equivalence to a predicate device:

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

Note: The document states "The results showed that outputs from Thirona LungQ 1.1.0 are equivalent to the predicate device, VIDA PW2," implying that all defined acceptance criteria were met. Specific numerical results for each metric proving equivalence are not provided beyond this general statement within the text.

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

• Sample Size: 250 CT scans.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the data is from the COPDGene study (http://www.copdgene.org), which is a U.S. based study.
  • Retrospective or Prospective: Retrospective, as scans were "randomly selected from the entire COPDGene cohort."

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

The "ground truth" for this equivalence study was established by the predicate device, VIDA PW2. Human experts were not used to establish a separate ground truth for comparison in this study. The study aims to show that LungQ's outputs are equivalent to those of an already FDA-cleared device.

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

Not applicable, as ground truth was established by the predicate device, not through human consensus or adjudication. The comparison was direct between the two software 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

No, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted for this equivalence study. This study focused on software-to-software equivalence.

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

Yes, an algorithm-only standalone performance study was done for both the LungQ software and the predicate device (VIDA PW2). The outputs of LungQ were directly compared to the outputs of VIDA PW2 to determine equivalence.

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

The ground truth for this equivalence study was the output of a legally marketed predicate device (VIDA PW2).

8. The sample size for the training set

The document does not explicitly state the sample size used for the training set of the LungQ software. The "Equivalence Study" describes the test set used for validation.

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

The document does not provide details on how the ground truth for the training set was established. The focus of this submission is on the non-clinical validation of the device against a predicate, not on the specifics of its development or training data.

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