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Dana reusable challenge 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 SteriScan Integrators.

Reusable SteriScan Integrator Test Pack for Steam

This document is a 510(k) clearance letter from the FDA for a medical device (Reusable SteriScan Integrator Test Pack for Steam Sterilization). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria. The FDA determined that the new device is as safe and effective as a legally marketed predicate device, therefore a detailed performance study as you've requested is typically not included or required for a 510(k) clearance.

Therefore, I cannot provide the requested information from the given input.

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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 steam sterilization cycles with 3M's 1292 Rapid Readout Biological Indicators along with or without SteriScan Integrators.

Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization.

Unfortunately, the provided document is a letter from the FDA regarding a 510(k) clearance for a Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization. It confirms substantial equivalence to a predicate device and provides information on regulatory compliance.

However, the document does not contain any information about the acceptance criteria and the study that proves the device meets those criteria. Specifically, the request asks for:

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

None of this information is present in the provided text. To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or similar technical documentation that details the testing performed for the device.

Ask a specific question about this device