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Banicide® Advanced is a reusable liquid chemical sterilant/high level disinfectant intended to (1) sterilize medical instruments at an exposure time of 10 hours and an exposure temperature of 25℃ and a minimum effective concentration of 1.8% glutaraldehyde; and (2) provide high level disinfection at an exposure time of 45 minutes and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde. It may be re-used for a period of 30 days provided the solution remains above the MEC as confirmed by a chemical indicator test strip.

Single container glutaraldehyde solution for sterilization and high level disinfection

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details for the Banicide® Advanced device:

Acceptance Criteria and Device Performance

The acceptance criteria for Banicide® Advanced are derived from its intended use as a liquid chemical sterilant and high-level disinfectant, and its comparison to predicate devices. The study demonstrates the device's efficacy against various microorganisms under specified conditions.

Table of Acceptance Criteria and Reported Device Performance

• Achieved 6-log reduction in Mycobacterium bovis (tuberculocidal) in 45 minutes at 25°C.
• Killed Trichophyton mentagrophytes (fungicidal) in 45 minutes at 22°C.
• Effectively disinfected flexible fiber optic endoscopes (simulated in-use) after 45 minutes at 22°C.
• Shown to be effective against a range of viruses (virucidal) in 45 minutes at 25°C. |
  | Reuse Period | Up to 30 days, provided glutaraldehyde concentration remains ≥ MEC | All performance testing (bactericidal, fungicidal, tuberculocidal, virucidal, simulated in-use) was conducted after 30 days of manual stressing to simulate worst-case reuse conditions. |
  | Sporicidal Activity | Kill B. subtillis and C. sporogenes spores | Passed AOAC Sporicidal Test against B. subtillis and C. sporogenes in 10 hours at 22°C. D-value of approximately one hour for B. subtillis. |
  | Bactericidal Activity | Kill S. aureus, P. aeruginosa, S. cholerasuis | No growth observed on carriers following 45 min exposure to 30-day stressed Banicide Advanced at 22°C. |
  | Tuberculocidal Activity | Kill Mycobacterium bovis | Achieved six-log reduction in Mycobacterium bovis in 45 minutes at 25°C. |
  | Fungicidal Activity | Kill Trichophyton mentagrophytes | Killed Trichophyton mentagrophytes within 45 minutes at 22°C. |
  | Virucidal Activity | Effective against relevant viruses | Effective against Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S in 45 minutes at 25°C. |
  | Material Compatibility | Compatible with medical instruments, including endoscopes | Documentation of general glutaraldehyde compatibility. Supplemental study showed compatibility with endoscopes under actual use conditions. |
  | Chemical Indicator Test Strip | Test strip available to verify MEC (1.8%) | Pascal confirmed the 3M Cold Sterilog™ 2.1% test strip is compatible. Test strip readings: no positive readings obtained at 1.8% or 1.7% glutaraldehyde, indicating it accurately detects below MEC. |

Study Details

The provided text describes a series of laboratory and simulated-use studies conducted to demonstrate the efficacy of Banicide® Advanced. All efficacy tests were conducted after the device was "30-day stressed" to simulate worst-case reuse conditions.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sporicidal Tests:
     • AOAC Sporicidal Test: Used "silk suture loops and porcelain penicylinders" for B. subtillis and C. sporogenes. Specific n not provided.
     • End-point analysis: "porcelain penicylinder carriers" inoculated with C. sporogenes. Specific n not provided.
     • Spore rate-of-kill (D-value): B. subtillis. Specific n not provided.
   • AOAC Use Dilution Test (Bactericidal): "steel penicylinder carriers" dried with S. aureus, P. aeruginosa, and S. cholerasuis. Specific n not provided.
   • AOAC Tuberculocidal Test: Tested against Mycobacterium bovis. Specific n not provided.
   • AOAC Fungicidal Test: Tested against Trichophyton mentagrophytes. Specific n not provided.
   • Simulated In-Use Test: "flexible fiber optic endoscopes". Specific n not provided.
   • Virucidal Efficacy Tests: Tested against 12 different viruses (Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S). Specific n not provided for each virus test.
   • In-Use Test: "a variety of endoscopes taken from an actual clinical setting." Specific n not provided.
   • Indicator Strip Testing: "Sets of 60 test strips were tested at each of 6 different concentrations" (2.4%, 2.2%, 2.0%, 1.8%, and 1.7% glutaraldehyde). This totals 60 strips/concentration * 5 concentrations = 300 test strips. (Note: The text states 6 concentrations, but only lists 5 specific ones. Assuming 6 unique concentrations were tested for the overall study design.)
   • Data Provenance: The studies appear to be laboratory-based efficacy tests, likely conducted in the US. The "In-Use Test" used endoscopes from "an actual clinical setting," implying prospective data collection during clinical use for that specific test. The material compatibility study for endoscopes was "supplemental" and provided "under actual conditions of use."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • The studies described are primarily laboratory-based microbiological efficacy tests following established AOAC (Association of Official Analytical Chemists) protocols. For such tests, the "ground truth" is typically the objective outcome of the assay (e.g., presence/absence of microbial growth, log reduction).
   • The text does not mention the use of human experts to establish "ground truth" for the test set in the same way one might for diagnostic imaging studies. The interpretation of the test results (e.g., counting colony forming units, observing viability) would be performed by trained microbiologists or laboratory technicians, whose qualifications are implicit in their ability to conduct these standard scientific tests.

3. Adjudication Method for the Test Set:

   • Not applicable as the tests are objective microbiological assays with clear pass/fail criteria or quantitative outcomes (e.g., log reduction, D-value). No mention of human adjudication for conflicting expert opinions.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images with and without AI assistance). Banicide® Advanced is a chemical sterilant/disinfectant, and its effectiveness is measured through microbiological and chemical efficacy, not human diagnostic performance.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance tests described are inherently "standalone" in that they evaluate the efficacy of the chemical solution itself without human intervention in the germicidal process. The efficacy is attributed solely to the Banicide® Advanced product under the specified conditions. Human involvement is limited to product application and handling as per instructions, and laboratory personnel conducting the tests and observing results.

6. Type of Ground Truth Used:

   • Microbiological Assay Results: For all sporicidal, bactericidal, tuberculocidal, fungicidal, and virucidal tests, the ground truth is the objective outcome of the microbiological assays (e.g., absence of growth, specific log reduction, viral inactivation).
   • Chemical Concentration Measurement: For the indicator strip testing, the ground truth is the actual measured glutaraldehyde concentration (e.g., 1.8%, 1.7%).
   • Direct Observation (In-Use/Material Compatibility): For the in-use tests on endoscopes and material compatibility, the ground truth is the direct observation of microbial recovery post-disinfection and absence of material damage.

7. Sample Size for the Training Set:

   • Not applicable. Banicide® Advanced is a chemical product, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its formulation and the basis for its efficacy are derived from chemical properties and established antimicrobial principles of glutaraldehyde.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" for this type of device. The efficacy is proven through direct testing rather than through an algorithmic learning process.

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