(18 days)
T.B.Q. RTU is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preciesn or decomationate cattical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
T.B.Q. RTU is a liquid chemical geamicide pump spray unilizing quatinary ammonium chloride compounds as active ingredients.
The provided document is a 510(k) summary for T.B.Q. RTU, a liquid chemical germicide. It describes the product, its intended use, and effectiveness data, but it does not describe an AI device or a study involving human readers. Therefore, I cannot generate the specific information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, acceptance criteria for an AI device).
However, I can extract the effectiveness data that serves as the "acceptance criteria" and "reported device performance" for this chemical germicide, as well as the types of studies performed, which are analogous to how a device's performance would be evaluated.
Here's the information based on the provided document, adapted to your requested format where possible:
Chemical Germicide Performance and Testing
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Result) |
|---|---|
| Germicidal: AOAC Germicidal Use-Dilution Test against S. aureus, S. choleraesuis and Ps. aeruginosa | Passes |
| Tuberculocidal: AOAC Tuberculocidal Test | Passes |
| Fungicidal: AOAC Fungicidal Test against T. mentagrophytes | Passes |
| Virucidal: Virucidal Qualification Test against Herpes simplex, Vaccinia and Adenovirus Type 5 | Passes |
| Virucidal: EPA approved Dilution Method against the HIV-1 (AIDS) virus | Passes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The tests refer to standardized methods (e.g., AOAC, EPA approved methods) which would have defined sample sizes for microbial cultures, but these specifics are not provided here.
- Data Provenance: Not specified. Standardized laboratory tests are generally conducted under controlled conditions, likely in the country of the manufacturer or a certified testing lab. The document does not indicate if the testing was retrospective or prospective, but these types of germicide efficacy tests are typically prospective laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to a chemical germicide efficacy study. The "ground truth" is established by the presence or absence of microbial growth based on laboratory culture methods, not by expert consensus or interpretation of images. The "experts" would be trained microbiologists performing the standardized assays. The number and qualifications are not listed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to chemical germicide testing. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., radiology reads), not for laboratory efficacy assays where results are typically objective (e.g., growth vs. no growth).
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 document describes a chemical germicide, not an AI device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a chemical germicide, not an algorithm or AI device. The efficacy testing is inherently "standalone" in the sense that it evaluates the chemical product's performance directly, without human intervention in the outcome determination beyond performing the assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For this chemical germicide, the "ground truth" is established by the survival or inactivation of specific microorganisms (bacteria, fungi, viruses) under controlled laboratory conditions, as determined by standardized microbiological culture and assay methods. For example, in the AOAC Use-Dilution Test, the ground truth is whether bacterial growth occurs in subculture tubes.
8. The sample size for the training set
- Not applicable. This document describes a chemical germicide, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for a chemical germicide.
§ 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.