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Aldahol® V High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 10.0 min at 20℃.

Aldahol V High Level Disinfectant is intended for the sterilization of reusable, clean, heatsensitive critical and semi-critical medical devices which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization available with a biological indicator, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 8.0 hrs at 20℃.

Aldahol V High Level Disinfectant may be used in a legally marketed, validated, automatic endoscope reprocessor machine or in a manual bucket system.

Device Description

Aldahol V High Level Disinfectant (HLD) is an aqueous solution that requires the combination of two parts: the light yellow unactivated Aldahol V HLD solution, packaged in gallon-sized containers, and a red Activator Buffer Salt Solution packaged in twelve ounce containers.

Once activated, the red/red-orange Aldahol V HLD as initially manufactured contains 3.40 ± 0.2% w/w glutaraldehyde and 20.1% ± 1% w/w isopropanol in a buffered salt solution with a pH value of about 7.6 to about 7.9, containing a surfactant, and potassium acetate salts all intended to enhance the antimicrobial activity of the solution.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for a chemical disinfectant, Aldahol® V High Level Disinfectant, rather than a medical device that would have traditional performance metrics like sensitivity, specificity, etc. This is a 510(k) summary for a liquid chemical sterilant/high-level disinfectant, and its performance is evaluated based on its ability to kill microorganisms under specific conditions.

Here's an organized breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
High-Level Disinfection (HLD)	Kill various microorganisms (bacteria, fungi, mycobacteria, viruses) when used at or above 1.8% glutaraldehyde for 10.0 min at 20°C.	Non-Clinical Efficacy Testing: Aldahol V HLD, stressed to the end of a 14-day reuse period and diluted to 1.8% w/w glutaraldehyde, was bactericidal (S. aureus, S. choleraesuis, P. aeruginosa; 10 min at 18°C), fungicidal (T. mentagrophytes, A. niger, C. albicans; 5 min at 18°C), tuberculocidal (>6 log10 M. terrae killed within 10 min at 20°C), and virucidal (Adenovirus Type 2, Herpes Simplex Virus Type 1, Human Influenza Virus A, Poliovirus Type 1; within 10 min at 20°C).
Simulated Use Tests: >6 log10 M. terrae killed in internal channels and external surfaces of bronchoscope, gastroscope, and colonoscope within 10 min at 20°C. Also, >6 log10 M. terrae killed in M. terrae-inoculated colonoscopes in an automated endoscope reprocessor machine within 10 min at ambient temperature.
Clinical Efficacy Testing: No bacteria recovered from cleaned patient-used endoscopes after 10 min exposure at 20°C to worst-case Aldahol V HLD (1.8% w/w glutaraldehyde).
Sterilization	Sterilize specific microorganisms (e.g., bacterial spores) when used at or above 1.8% glutaraldehyde for 8.0 hrs at 20°C.	Non-Clinical Efficacy Testing: Aldahol V HLD was sporicidal (B. subtilis and C. sporogenes inoculated porcelain penicylinders and silk suture loops sterilized within 8.0 hours of exposure at 20°C).
Simulated Use Tests: >6 log10 B. subtilis killed in bronchoscope and colonoscope within 6.0 hours exposure at 20°C, demonstrating a margin of safety for the 8.0 hour sterilization time.
Minimum Recommended Concentration (MRC) Monitoring	The concentration of glutaraldehyde can be monitored to ensure it remains at or above the MRC of 1.8% w/w glutaraldehyde.	3M Comply 1.8% Glutaraldehyde Monitor Strips Catalog No. 3987 and MetriTest 1.8% glutaraldehyde concentration monitor Reorder No. 10-304 were able to measure glutaraldehyde concentration at its MRC of 1.8% w/w or greater. (Note: 3M strips routinely fail at 2.3% or 2.4% glutaraldehyde, indicating they are sensitive enough to detect when the concentration drops below 1.8%).
Re-use Period & Stability	Maintain efficacy for 14 days or until the glutaraldehyde concentration declines below the MRC.	Aldahol V HLD was tested at the end of a 14-day reuse period in an Environmental Protection Agency Use and Re-Use Test and demonstrated efficacy. The glutaraldehyde concentration remains constant over 14 days, declining only due to inadvertent dilution. Stability data from the identical Aldahol III HLD (18 months shelf-life) was leveraged.
Biocompatibility	Residues remaining on devices after use and rinsing are below toxic concentrations.	Residues of glutaraldehyde and isopropanol after sterilization/HLD and three separate water rinses were below toxic concentrations as reported in the literature. This was based on the identical formulation of Aldahol III HLD.
Material Compatibility	Compatible with endoscopes and common medical materials.	Compatible with endoscopes and a variety of materials common in medical facilities at 20°C, with the exception of brass and copper after 7 hours. Data was leveraged from the identical Aldahol III HLD, which has been in use with endoscopes since 2010.

Study Details

This submission is for a chemical disinfectant, not a device with AI components or image-based diagnostics. Therefore, many of the requested fields regarding sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable in this context. The studies primarily involve laboratory (in vitro) and simulated-use (ex vivo) microbiological testing, along with a limited clinical in-use test.

Here's a breakdown of the relevant information provided:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Efficacy Testing (In Vitro): Specific numbers of organisms (e.g., >6 log10 reduction for mycobacteria) are measured, but the exact number of replicates or samples per test is not explicitly stated, although standard methods (e.g., AOAC Use-Dilution Tests, AOAC Fungicidal Test, AOAC Sporicidal Test) imply a defined number of tests.
- Simulated Use Tests: A bronchoscope, gastroscope, and colonoscope were inoculated with cultures of M. terrae and B. subtilis. The results are reported as successful killing (> 6 log10 reduction). Another simulated use test was conducted by Olympus Medical Systems Corporation in Tokyo, Japan, using M. terrae-inoculated colonoscopes in an automated endoscope reprocessor. The exact number of each type of endoscope or repetitions is not specified.
- Clinical Efficacy Testing: Bronchoscopes, gastroscopes, and colonoscopes "as received directly from patients" at an endoscopy department were used. The number of each type of endoscope or total number of endoscopes is not specified.
- Data Provenance:
  - Non-Clinical Efficacy Testing: Implied to be lab-based, likely MicroChem Laboratory, Inc.
  - Simulated Use Tests: Some conducted by the applicant, others by Olympus Medical Systems Corporation in Tokyo, Japan.
  - Clinical Efficacy Testing: Conducted with endoscopes from "an endoscopy department within a hospital," location unspecified but likely US-based given the FDA submission.
  - All tests appear to be prospective for the purpose of this submission to demonstrate the product's efficacy.
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)
- Not applicable for a chemical disinfectant. The "ground truth" for efficacy is the objective determination of microbial kill or absence of viable microorganisms, typically performed by trained microbiologists following validated aseptic and culturing techniques. There is no mention of "experts" in the sense of clinical specialists interpreting results (like radiologists).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a chemical disinfectant. This concept applies to human interpretation of data, often in clinical trials or diagnostic accuracy studies. Microbiological testing relies on quantitative and qualitative lab methods rather than adjudication.
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 a chemical disinfectant, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a chemical disinfectant.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For efficacy testing (HLD and sterilization): The ground truth is the microbiological count/viability of specified challenge organisms (e.g., bacteria, fungi, mycobacteria, viruses, spores) before and after exposure to the disinfectant, and the subsequent recovery (or lack thereof) of viable organisms through standard culture methods. This is an objective, laboratory-derived ground truth.
- For biocompatibility and material compatibility: The ground truth is established through chemical analysis (residue levels) and visual/material integrity assessment after exposure.
The sample size for the training set
- Not applicable. This is not a machine learning or AI-based device.
How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI-based device.

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