Search Results

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 steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Dana Reusable Test Pack." While it states the intended use and regulation information, it does not contain the detailed acceptance criteria or a study that proves the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
5. Information about standalone algorithm performance.
6. The type of ground truth used.
7. Training set sample size or how its ground truth was established.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance, but it does not provide the underlying performance study details that would typically include acceptance criteria and specific performance metrics.

Ask a specific question about this device