(200 days)
The Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.
Rapicide PA High-Level Disinfectant Test Strips have the ability to measure the disinfectant use solution concentration above 850ppm PAA. This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black color.
The Medivators Rapicide PA High-Level Disinfectant Test Strips are designed to ensure that the Rapicide PA High-Level Disinfectant Solution is above its minimum recommended concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning a solid black color when the solution is above 850ppm PAA, while a "fail" is indicated by the pad turning dark grey, violet grey, light grey, or white (no color change) if the solution is at or below the MRC.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Range | Negative response at concentrations at or below MRC, positive response at higher concentrations. | Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive response at higher concentrations. |
| Comparative Sensitivity and Specificity | Comparative sensitivity and specificity of 1 (implicitly, indicating perfect agreement with a reference method or ideal performance). | Met Acceptance Criteria: Comparative sensitivity and specificity of 1. |
| Analytic Specificity – Contaminants | Negative response at MRC (for contaminants), positive response at higher concentration (for the active ingredient). (This implies the device should not give a false positive due to contaminants at MRC, and correctly identify the active ingredient above MRC). | Met Acceptance Criteria: Negative response at MRC, positive response at higher concentration. |
| Analytic Specificity - Other Germicides | Negative response to other germicides. (Ensuring the device is specific to peracetic acid and does not react with other common germicides). | Met Acceptance Criteria: Negative response to other germicides. |
| Shelf Life | Met specifications after storage for a labeled shelf life of 12 months (unopened). | Met Acceptance Criteria: Met specifications after storage for labeled shelf life of 12 months (unopened). |
| In-Use (Open Bottle) Stability | Met specifications after storage for a labeled open bottle shelf life of one month. | Met Acceptance Criteria: Met specifications after storage for labeled open bottle shelf life of one month. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each of the tests (Dynamic Range, Comparative Sensitivity and Specificity, Analytic Specificity – Contaminants, Analytic Specificity - Other Germicides, Shelf Life, In-Use Stability). It only indicates that "non-clinical tests" were performed.
The data provenance is from Medivators Inc., a company based in Minneapolis, MN, USA. The data is retrospective as it was generated prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a chemical indicator, the ground truth would likely be established by a laboratory assay (e.g., titration or spectrophotometry) to precisely determine the peracetic acid concentration, rather than by human experts interpreting the results.
4. Adjudication method for the test set:
This information is not applicable as the test strips are chemical indicators with a direct visual output (color change). The outcome is determined by the specific chemical reaction embedded in the strip, not by expert adjudication.
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 is not applicable. The device is a chemical test strip, not an AI-powered diagnostic tool requiring human interpretation with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a chemical test strip, not an algorithm. The "standalone" performance is the inherent chemical reaction on the strip.
7. The type of ground truth used:
The ground truth used for these chemical test strips would be the actual concentration of peracetic acid in the disinfectant solution, determined by a precise analytical method (e.g., chemical titration, spectrophotometry, or a validated reference standard). The document implies this by referring to "concentrations at or below MRC" and "higher concentrations."
8. The sample size for the training set:
This information is not provided as chemical test strips do not typically involve a "training set" in the context of machine learning or AI. The performance of the test strip is a result of its chemical formulation and manufacturing process, optimized through R&D and verified through testing.
9. How the ground truth for the training set was established:
This is not applicable as there isn't a "training set" in the traditional sense for these chemical test strips. The chemical composition is designed to react at specific concentrations, and the ground truth for validating this design (during R&D and manufacturing quality control) would be established using precise analytical methods to determine peracetic acid concentrations in control solutions.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).