(68 days)
CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).
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The provided text is a US FDA 510(k) clearance letter for a device named "CITREX® Hospital Spray Disinfectant". This document primarily deals with the regulatory approval of a disinfectant and does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance.
The questions you've asked are typically relevant to the evaluation of AI/ML-powered medical devices, which are a different category of product from a chemical disinfectant. Therefore, most of the information requested cannot be extracted from this document because it describes a different type of product and approval process.
Here's a breakdown of what can be inferred from the document regarding its intended use:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or provide performance metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, the "performance" is implicitly tied to its function as an "intermediate level disinfectant" and its ability to act as a "cleaner/disinfectant of Non-Critical devices" and hard surfaces, intended for "environmental control of bacteria." The key performance characteristic mentioned is a "one minute contact time at room temperature."
2. Sample size used for the test set and the data provenance: Not applicable. This is a chemical disinfectant, not an AI/ML device relying on a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is irrelevant for a disinfectant. Its efficacy would typically be established through microbiology lab tests, not expert consensus on data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For a disinfectant, the "ground truth" would be established through standard microbiological assaysdemonstrating antimicrobial efficacy against specific pathogens under defined conditions. The document does not detail these studies, but FDA clearance implies such testing was performed and reviewed.
8. The sample size for the training set: Not applicable. This is a chemical product, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a regulatory approval for a chemical disinfectant, not an AI/ML medical device. Therefore, the questions posed, which are designed for evaluating AI/ML systems, are largely not applicable to this context, and the document does not contain the specific information requested.
§ 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.