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ClearRead +Confirm is intended to generate an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes. The enhanced AP or PA image of the chest provides improved visibility of lines and tubes. The ClearRead +Confirm image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians, on patients with lines and tubes and is not intended to be used on pediatric patients.

ClearRead +Confirm is a dedicated post-processing application that generates an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the specified format:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The text mentions it was a "multi-reader multicase (MRMC) study," implying a collection of cases, but the specific number is not given. However, the study was "clinical validation," implying prospective or retrospective clinical data. No country of origin is specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The study involved "radiologists" as readers, but how many established ground truth, or their specific qualifications (e.g., years of experience), is not detailed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. The text mentions "true locations," implying that a ground truth was established, but the method of adjudication (e.g., consensus, by an expert panel) is not described.

4. 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:

   • Yes, a multi-reader multicase (MRMC) study was done.
   • Effect Size: The study found a "significant decrease" in read times when using ClearRead +Confirm. The specific quantitative "effect size" (e.g., percentage reduction, time saved in seconds) is not provided, only that it was statistically significant. For accuracy, no statistically significant difference from true locations was found between ClearRead +Confirm reads and unaided reads.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document does not explicitly state whether a standalone performance study was conducted. The focus is on the human-in-the-loop performance through the MRMC study, where the device provides "adjunctive information."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The text refers to "true locations" of tubes, lines, and electrical cardiac wires (TLW). This broadly suggests an expert-determined ground truth, likely based on anatomical knowledge and possibly confirmed by other imaging or clinical data, but the exact method (e.g., expert consensus) is not specified.

7. The sample size for the training set: Not provided in the document.

8. How the ground truth for the training set was established: Not provided in the document.

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