(57 days)
Germicidal Cloth is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces.
Germicidal Cloth is a liquid chemical germicide saturated, disposable cloth utilizing quatinary ammonium chloride compounds as active ingredients.
This document describes a 510(k) submission for a germicidal cloth and does not contain detailed information about a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically found for complex medical devices with AI components. The provided text is a regulatory submission for a disinfectant product, focusing on its formulation, intended use, and comparison to substantially equivalent products, along with safety and basic effectiveness data.
Therefore, an elaborate table of acceptance criteria, device performance, and details about a "study" as requested, particularly in the context of AI/machine learning, cannot be extracted directly from the provided text. The "Effectiveness Data" section acts as the closest equivalent to performance metrics based on standard disinfectant testing.
However, I will extract relevant information that can be framed as "acceptance criteria" and "reported device performance" based on the product's regulatory approval as a germicide.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by EPA Approval) | Reported Device Performance (Status from Effectiveness Data) |
|---|---|---|
| Germicidal Efficacy | Inactivation of specific bacteria | Approved by EPA against S. aureus, S. cholejacans, Ps. aeruginosa, and other bacteria. |
| Tuberculocidal Efficacy | Inactivation of Mycobacterium bovis | Approved by EPA against Mycobacterium bovis (BCG). |
| Fungicidal Efficacy | Inactivation of pathogenic fungi | Approved by EPA against pathogenic fungi. |
| Virucidal Efficacy | Inactivation of specific viruses | Approved by EPA against Adenovirus Type 5, Canine Distemper, Herpes simplex Type 2 Virus, HIV-1, Influenza A-HK Virus, Pseudorabies Virus, and Vaccinia Virus. |
| Acute Oral Toxicity | LD50 (Rats) > 5,000 mg/kg | 5,000 mg/kg |
| Acute Dermal Toxicity | LD50 > 2,000 mg/kg | > 2,000 mg/kg |
| Dermal Irritation | Mild or no irritation | Produced mild transient redness and swelling |
| Eye Irritation | Mild or no irritation | Produced mild transient eye irritation |
| Dermal Sensitization | Negative as sensitizer | Negative as sensitizer |
Based on the provided text, the following information is either not applicable or not available:
- 2. Sample size used for the test set and data provenance: Not mentioned. Effectiveness data refers to EPA approvals, implying testing was done, but details of sample size and data provenance (e.g., country, retrospective/prospective) are not provided in this summary.
- 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. For germicidal efficacy, "ground truth" is established through standardized laboratory assays (e.g., AOAC methods for disinfectants) rather than expert consensus on medical images or clinical outcomes.
- 4. Adjudication method for the test set: Not applicable. Standardized lab protocols are followed, not expert adjudication methods common in diagnostic device studies.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic devices involving human interpretation of results, not for chemical germicides.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a chemical disinfectant, not an algorithm.
- 7. The type of ground truth used: For efficacy, the "ground truth" is determined by the results of standardized microbiological assays (e.g., quantitative suspension tests, carrier tests) that measure the reduction of viable microorganisms under specified conditions. For safety, it's based on animal toxicology studies.
- 8. The sample size for the training set: Not applicable. This document describes a chemical product, not a machine learning model.
- 9. How the ground truth for the training set was established: Not applicable for this type of device.
§ 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.