(27 days)
General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces in dental, medical, hospital, and veterinary facilities.
Not Found
I am sorry, but the provided text does not contain the detailed information needed to construct the table and answer the questions regarding acceptance criteria, study details, and performance metrics of the device "Microstat 2™".
The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (general purpose disinfectant). It confirms that the device can be marketed but does not include:
- Specific acceptance criteria (e.g., performance thresholds).
- Details of a study proving device performance (e.g., methodology, results, sample sizes, ground truth establishment, expert qualifications, adjudication methods).
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot fulfill your request with the given input.
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.