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The Bismuth Process Indicator Steam Sterilization Tape is in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 ℃ for 3 minutes and 135 ℃ for 10 minutes or pre-vacuum sterilizers operating at 132℃ for 3 minutes; 132 °C for 4 minutes; 134 °C for 3 minutes and 135°C for 3 minutes. The indicator lines turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

The process indicator tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with beige indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.

The provided text describes the acceptance criteria and study results for the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape. This device is a chemical indicator designed to distinguish between sterilized and unsterilized items.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative "Passed" or "Failed" based on visual change or adherence.

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

The document does not explicitly state a specific numerical "sample size" for the various tests. However, it indicates that testing was performed "in accordance with" established standards (ANSVAAMI/ISO 11140-1:2014, FDA Chemical Indicator Guidance Document, PSTC-101 and PSTC-131) which would specify the number of samples or replicates required for each test. For example, the PSTC adhesion test specifies "five tests".

The data provenance is not explicitly detailed in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or on behalf of Intertape Polymer Inc. for regulatory submission to the FDA. The nature of these tests (performance, shelf-life, biocompatibility in controlled environments) suggests they are prospective laboratory and in-use studies.

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. The "ground truth" for a chemical indicator like this is a direct physical or chemical change (color change due to exposure to steam sterilization conditions, or physical adherence). It does not involve human interpretation or expert consensus in the way a diagnostic imaging AI would, where radiologists establish ground truth for image classification. The "ground truth" is based on the physical parameters of the sterilization cycle and the expected reaction of the chemical indicator.

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

Not applicable. As explained above, the assessment of the chemical indicator's performance is based on direct physical observation (color change, adhesion) relative to defined standards and manufacturer specifications, not subjective human opinion requiring adjudication.

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:

Not applicable. This device is a chemical process indicator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this device.

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

Not applicable. This device is a physical/chemical indicator, not a software algorithm. Its "standalone performance" is its inherent reaction to steam sterilization conditions, which is what the performance testing evaluated.

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

The ground truth used is primarily based on controlled physical and chemical conditions (e.g., specific temperatures, times, and steam exposure levels in resistometers and actual sterilizers) as defined by established international and FDA standards (ANSVAAMI/ISO 11140-1:2014, FDA Chemical Indicator Guidance Document, PSTC standards). The expected "truth" is a specific visual change (dark brown/black color) upon exposure to these conditions and maintained physical properties (adhesion, lack of bleeding).

8. The sample size for the training set:

Not applicable. This device is a hardware chemical indicator, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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