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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

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.

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T.B.Q. is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental suffaces in healthcare facilities.

T.B.Q. is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.

This document is a 510(k) summary for a general-purpose disinfectant called T.B.Q. It describes the product, its intended use, and substantial equivalence to other products. The document also includes safety and effectiveness data. However, it does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of medical imaging, AI algorithms, or similar diagnostic technologies.

The information provided relates to a chemical germicide and its efficacy against various microorganisms, not a medical device in the typical sense of needing performance metrics like sensitivity, specificity, or reader studies.

Therefore, many of the requested fields are not applicable to the provided input. I will fill in what can be inferred or state "Not Applicable" where the information is clearly outside the scope of a chemical germicide approval document.

Here's an attempt to address your request based on the provided text, while acknowledging its limitations:

Acceptance Criteria and Performance Study for T.B.Q. General Purpose Disinfectant

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated as a number of "samples" in the way a diagnostic device would. For the efficacy tests, the "sample size" refers to the number of bacterial/fungal/viral cultures or test surfaces used for each specific test (e.g., S. aureus in 400ppm hard water at 1:64 dilution). The specific quantity for each test is not detailed in this summary.
• Data provenance: Not specified. Standardized AOAC (Association of Official Analytical Chemists) and EPA (Environmental Protection Agency) test methods are generally conducted in a laboratory setting. It is implied these are prospective laboratory tests conducted to evaluate the product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document pertains to the efficacy of a chemical disinfectant against microorganisms, not a diagnostic device requiring expert interpretation of images or patient data to establish "ground truth." The "ground truth" here is determined by the standardized laboratory protocols for germicidal, tuberculocidal, fungicidal, and virucidal activity.

4. Adjudication method for the test set

• Not Applicable. No adjudication method is described. The results of the standardized tests (e.g., presence or absence of growth, or viral inactivation) are typically objective and measured according to the test protocols.

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 a medical imaging device with human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for the efficacy data is established through standardized laboratory testing protocols (e.g., AOAC Germicidal Use-Dilution Test, AOAC Tuberculocidal Test, AOAC Fungicidal Test, Virucidal Qualification Test, EPA approved Dilution Method). These methods define what constitutes a "pass" or "fail" for inactivation of specific microorganisms under specified conditions. For safety data, it is based on standard toxicological assays (LD50, LC50, irritation indices) in animal models.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI/ML device that requires a training set.

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