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Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum 4 minute steam sterilization cycles with the Dana Emulating Indicator cleared by FDA under K100891.

Reusable Integrator Test Pack for Dana Emulating Indicator.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Reusable Integrator Test Pack for Dana Emulating Indicator." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance. It is a regulatory clearance, not a scientific study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

To obtain this information, you would typically need to refer to the original 510(k) submission (K110253) made by Dana Products, Inc. to the FDA. Such submissions contain the technical data, study protocols, and results that demonstrate the device meets its intended performance and regulatory requirements. These documents are usually not publicly available in full detail through a simple clearance letter.

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Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature : 270°F (132°C) Time: 4 Minutes

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The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device called "Dana Emulating Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not present in the FDA letter. The letter only refers to "indications for use" as stated in the enclosure, but the details of performance criteria and actual test results are absent.
• Sample size and data provenance: Not mentioned.
• Number of experts and qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone performance: Not mentioned.
• Type of ground truth: Not mentioned.
• Sample size for training set: Not applicable for this type of device (it's a physical indicator, not an AI/software device).
• Ground truth for training set: Not applicable.

The "Indications for Use" section (page 2) describes what the device is intended to do and the specific parameters it's designed to monitor in a sterilization process:

Device Name: Dana Emulating Indicator

Indications For Use: "Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met."

Critical Parameters:

• Temperature: 270°F (132°C)
• Time: 4 Minutes

While these are the conditions the device is designed to indicate, the document does not provide the specific performance acceptance criteria (e.g., how accurate is the "dark bar travel" or what tolerance it has) nor does it provide a study report demonstrating its performance against such criteria. This kind of detail would typically be found in the actual 510(k) submission document or a separate test report, not in the FDA's decision letter.

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