(21 days)
Coverage Spray HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Coverage Spray HBV is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
This document describes a general-purpose disinfectant, Coverage Spray HBV, and its effectiveness against various microorganisms. However, the provided text does not contain information about a "device" in the context of medical devices or AI algorithms that would require the detailed study parameters you've requested (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance).
The information given relates to a disinfectant's chemical properties and its approval by the EPA for germicidal, fungicidal, and virucidal activity. The "acceptance criteria" here refer to the EPA's standards for efficacy, rather than performance metrics for an AI or medical device.
Therefore, I cannot provide the requested table and study details in the format you've outlined because the input document does not describe the kind of product or study that would generate such data.
The relevant information from the input text regarding "acceptance criteria" and "device performance" (in this case, disinfectant performance) can be summarized as:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Microorganism | Reported Performance/Approval Status |
|---|---|---|
| Germicidal | S. aureus | Approved by EPA |
| S. choleraesuis | Approved by EPA | |
| Ps. aeruginosa | Approved by EPA | |
| Other bacteria | Approved by EPA | |
| Fungicidal | Pathogenic fungi | Approved by EPA |
| Aspergillus niger | Approved by EPA | |
| Virucidal | Hepatitis B Virus | Approved by EPA |
| HIV-1 | Approved by EPA | |
| Herpes simplex Type 1 | Approved by EPA | |
| Herpes simplex Type 2 | Approved by EPA | |
| Parainfluenza Type 1 Virus | Approved by EPA | |
| Pseudorabies Virus | Approved by EPA | |
| Influenza A Virus | Approved by EPA | |
| Influenza B Virus | Approved by EPA | |
| Measles Virus | Approved by EPA |
Missing Information (Not Applicable to Disinfectant Approval Documentation):
The following information categories are not relevant or available for a chemical disinfectant approval document:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
This document reports on the EPA approval of a disinfectant based on standardized laboratory tests against specific microbial strains, not on clinical trials or AI performance evaluations.
§ 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.