(84 days)
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
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Germicidal Efficacy | Pass AOAC Germicidal Use-Dilution Test in 400ppm hard water at 1:64 dilution against S. aureus, S. choleraesus, Ps. aeruginosa. | Passes AOAC Germicidal Use-Dilution Test in 400ppm hard water at a 1:64 dilution against S. aureus, S. choleraesus and Ps. aeruginosa. |
| Pass AOAC Germicidal Use-Dilution Test in distilled water at 1:128 dilution against S. aureus, S. choleraesus, Ps. aeruginosa. | Passes AOAC Germicidal Use-Dilution Test in distilled water at a 1:128 dilution against S. aureus, S. choleraesus and Ps. aeruginosa. | |
| Tuberculocidal Efficacy | Pass AOAC Tuberculocidal Test at 1:128 dilution in distilled water. | Passes AOAC Tuberculocidal Test at a 1:128 dilution in distilled water. |
| Fungicidal Efficacy | Pass AOAC Fungicidal Test in 400 ppm hard water at 1:64 dilution against T. mentagrophytes. | Passes AOAC Fungicidal Test in 400 ppm hard water at a 1:64 dilution against T. mentagrophytes. |
| Pass AOAC Fungicidal Test in distilled water at 1:128 dilution against T. mentagrophytes. | Passes AOAC Fungicidal Test in distilled water at a 1:128 dilution against T. mentagrophytes. | |
| Virucidal Efficacy | Pass Virucidal Qualification Test in 400 ppm hard water at 1:64 dilution against Influenza An, Herpes simplex, Vaccinia and Adenovirus Type 5. | Passes Virucidal Qualification Test in 400 ppm hard water at a 1:64 dilution against Influenza An, Herpes simplex, Vaccinia and Adenovirus Type 5. |
| Pass EPA approved Dilution Method in 400 ppm hard water at 1:64 dilution against HIV-1 (AIDS) virus. | Passes EPA approved Dilution Method in 400 ppm hard water at a 1:64 dilution against the HIV-1 (AIDS) virus. | |
| Safety - Acute Oral LD50 | Not explicitly stated as a pass/fail criterion, but a common toxicological measure. Implies a threshold for acceptable toxicity. | 1,900 mg/kg (Rats) |
| Safety - Acute Inhalation LC50 | Not explicitly stated as a pass/fail criterion. | >2.2 ml/ft3 |
| Safety - Dermal Irritation (neat) | Primary Irritation Index (Draize Scale) indicating acceptable irritation level for the neat product. | 5.38 (Moderate Irritation) - The acceptance criterion would depend on regulatory limits for "moderate." This value is reported. |
| Safety - Dermal Irritation (1:64 dilution) | Primary Irritation Index (Draize Scale) indicating acceptable irritation level for the use-dilution product. | 0.09 (Barely Perceptible Irritation) - This would typically be well within acceptable limits for a use-dilution. |
| Safety - Eye Irritation (neat) | Not corrosive. | Corrosive - The acceptance criterion for the neat product might allow this given it's a concentrate, but it would require specific labeling and handling instructions. The diluted product's performance is more critical for user safety. |
| Safety - Eye Irritation (1:64 dilution) | No irritation. | No irritation. |
| Safety - Dermal Sensitization | Negative as sensitizer. | Negative as sensitizer. |
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.
§ 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.