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510(k) Data Aggregation
(17 days)
Coverage HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Coverage HBV is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
The provided text describes a disinfectant product, Coverage HBV, and its effectiveness against various microorganisms. It is not a medical device in the context of AI/ML or image analysis, so the requested information categories regarding acceptance criteria, study methodologies, expert involvement, and ground truth establishment (which are typical for AI/ML-based medical devices) are not applicable.
However, I can extract the information that is present and indicate where the requested categories are not relevant for this type of product.
Description of Coverage HBV and its Effectiveness:
This document is a 510(k) Summary for a General Purpose Disinfectant named Coverage HBV.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Relevant for AI/ML devices, described for disinfectant effectiveness here) | Reported Performance (Disinfectant Effectiveness) |
|---|---|
| Germicidal Efficacy | Approved by EPA as effective against: * S. aureus * S. choleraesuis * Ps. aeruginosa * Other bacteria |
| Fungicidal Efficacy | Approved by EPA as effective against: * T. mentagrophytes * Aspergillus candidus * Aspergillus niger * Candida albicans * Penicillium chermesinum * Penicillin oxalicum * Penicillium spinulosum * Ulocladium sp. |
| Virucidal Efficacy | Approved by EPA as effective against: * Avian Influenza/Turkey/Wisconsin Virus * Cytomegalovirus * Hepatitis B Virus * Herpes Simplex type 2 Virus * Influenza A Virus * Influenza B Virus * Influenza C Virus * Measles Virus * Newcastle Disease Virus * Parainfluenza type 1 Virus * Poliovirus type 1 * Porcine Parovirus * Pseudorabies Virus * T1 bacteriophage * T4 bacteriophage * Vaccinia |
| Safety Data | Acute Oral LD50 (Rats) = 5,000 mg/kg |
| Acute Dermal LD50 (Rabbits) = 2,000 mg/kg | |
| Dermal Irritation (Rabbit) neat = Corrosive | |
| Eye Irritation (Rabbit) neat = Severe nonreversible irritation | |
| Eye Irritation (Rabbit) 1:64 aqueous dilution = No irritation | |
| Dermal Sensitization (Guinea Pig) = Negative as sensitizer |
Explanation of Non-Applicability for AI/ML-specific questions:
The following requested points are specific to the study and validation of AI/ML-based medical devices, which Coverage HBV (a chemical disinfectant) is not. Therefore, this information is not available or relevant in the provided text.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a chemical disinfectant. The "test set" here refers to the microorganisms and toxicology models used in laboratory effectiveness and safety studies, not a digital dataset.
- 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. Ground truth for a disinfectant is established through standardized microbiological and toxicological laboratory assays, not expert clinical review.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI-assisted human reading tasks.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a disinfectant, the "ground truth" is determined by the results of standardized laboratory tests demonstrating microbial inactivation and safety, as regulated by bodies like the EPA.
- The sample size for the training set: Not applicable. This refers to AI model training data.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the effectiveness and safety profiles of a chemical disinfectant according to regulatory approvals (EPA) rather than the performance metrics and study designs typically associated with AI/ML medical devices.
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