(149 days)
Opaciden Solution is a high level disinfectant for reprocessing heat-sensitive medical devices for which sterilization is not suitable, and when used according to the Directions for Use. Opaciden may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20° C (68° F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25° C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25° C (77° F), for a reuse period not to exceed 14 days.
Opaciden Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30°C (59-86°F) for its labeled shelf life. The product may be used or reused (up to 14 days) for manual or automated reprocessing, according to the Directions for Use. Opaciden Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.
The provided text describes a 510(k) summary for a high-level disinfectant called Opaciden Solution. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive performance study summary.
The document primarily focuses on establishing substantial equivalence to a predicate device (CIDEX® OPA Solution) and describes the device's intended use and technological characteristics. It mentions "performance testing" but does not provide specific acceptance criteria or detailed results.
Here's a breakdown of what can and cannot be extracted from the provided text, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. While it states, "All test results were acceptable and demonstrated performance in accordance with the product labeling," it does not specify what those acceptance criteria were (e.g., specific log reduction values for microorganisms) or the quantitative performance results (e.g., "achieved X log reduction for Y organism").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The text mentions "tested, in both the manual and automated reprocessing modes," but does not give details about the samples (e.g., number of devices disinfected, types of microorganisms tested, or specific test conditions). It also does not specify data provenance.
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 information is not applicable/provided. For a chemical disinfectant, "ground truth" typically refers to the confirmed microbial reduction or inactivation, which is determined through laboratory assays, not by expert consensus on images or clinical assessments. The document doesn't detail the methodology for establishing the efficacy ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or clinical outcomes, where disagreements need to be resolved. For a disinfectant performance study, the outcome is usually based on quantitative laboratory measurements.
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
This information is not applicable. An MRMC study is relevant for medical imaging AI devices where human readers interpret cases. Opaciden Solution is a high-level disinfectant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question is for AI algorithms. Opaciden Solution is a chemical disinfectant. Its performance is inherent to the chemical formulation and its interaction with microorganisms, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for a chemical disinfectant's performance would be established through microbiological assays, demonstrating the reduction or inactivation of specific challenge microorganisms (e.g., bacteria, viruses, fungi, spores) to a certain log reduction level, as specified by regulatory standards for high-level disinfectants. However, the document does not explicitly state the type of ground truth used, only that "All test results were acceptable."
8. The sample size for the training set
This information is not applicable/provided. Training sets are relevant for machine learning or AI models. Opaciden Solution is a chemical product, not an AI system.
9. How the ground truth for the training set was established
This information is not applicable/provided. Same as above, training sets and their ground truth establishment are for AI/ML models.
In summary:
The provided 510(k) summary for Opaciden Solution indicates that performance testing was conducted according to FDA guidance for high-level disinfectants. It claims that "All test results were acceptable and demonstrated performance in accordance with the product labeling, as well as substantial equivalence to the predicate device." However, it lacks the specific details of these performance tests, including quantitative acceptance criteria, actual performance metrics, sample sizes, and detailed methodology, which would be necessary to answer the questions comprehensively. The document is a summary focused on regulatory clearance based on substantial equivalence, not a detailed scientific study report.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.