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The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators". This document typically outlines the FDA's decision on substantial equivalence based on data submitted by the manufacturer. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study results.

The document states:

• Device Name: Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators
• Intended Use: For testing the air removal efficiency of pre-vacuum steam sterilizers.
• Performance Claim: The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window).
• Test Parameters for Validation: 134℃ for 3.5 minutes with a 2-minute dry time.

Based on the information provided in the given document, I cannot provide a complete answer to your request. The document is a regulatory approval letter, not a detailed scientific study report. It states that the device is "substantially equivalent" to predicate devices, implying that testing was conducted, but it does not include the specifics of that testing.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided document):

• 2. Sample size used for the test set and the data provenance: Not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. The ground truth here is a physical condition (temperature difference, vacuum presence/absence) measured by instruments, not expert interpretation of an image or signal.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (ground truth is instrumental/physical).
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is a chemical indicator, not an AI or imaging device requiring human interpretation for its primary function.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone indicator. Its "performance" is whether the dye changes correctly. There's no AI algorithm or human-in-the-loop for its direct function.
• 7. The type of ground truth used: Based on the description, the ground truth is physical measurement of sterilization conditions, specifically the temperature difference in a standard test pack and the presence/absence of proper vacuum, conforming to ANSVAAMI/ISO 11140-5:2007 Standard. This is not expert consensus, pathology, or outcomes data in the traditional sense.
• 8. The sample size for the training set: Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model. The device's performance is based on its chemical and physical properties.
• 9. How the ground truth for the training set was established: Not applicable.

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