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Terragene Chemdye® Bowie-Dick Test Pack (BD125X/1), Bowie-Dick Test Card (BD8948X/1) and Bowie-Dick Test Sheet (BDA4/1) are designed for testing air removal efficiency for cycles of 132ºC for 3.5 minutes in dynamicair-removal steam sterilizers.

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This document is a marketing authorization letter for a device and therefore does not contain the detailed information necessary to answer some of the questions. Specifically, it does not include information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

However, based on the provided text, here's what can be extracted:

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

This information is not available in the provided document. The document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.

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

This information is not available in the provided document.

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 available in the provided document.

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

This information is not available in the provided document.

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 available in the provided document. The device, Terragene Chemdye® Bowie-Dick Test Pack, Bowie-Dick Test Card, and Bowie-Dick Test Sheet, are chemical indicators for sterilization processes, not an AI-powered diagnostic tool that would typically involve human readers.

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

This information is not applicable/not available for this type of device. The devices are chemical indicators that change color to show air removal efficiency, and their performance is inherently standalone in their function (i.e., they indicate a condition without human interpretation of an algorithm's output).

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

This information is not available in the provided document. For Bowie-Dick tests, the "ground truth" would typically be established based on standardized test procedures and expected color changes under validated sterilization conditions.

8. The sample size for the training set:

This information is not applicable/not available in the provided document. The devices are chemical indicators, not machine learning algorithms that require a "training set."

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

This information is not applicable/not available for this type of device.

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