(175 days)
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:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- 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.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).