(94 days)
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in the solutions listed below, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD)
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a chemical indicator strip consisting of an indicator pad attached to a polymer substrate which serves as a handle. The test strip has been developed to monitor the concentration of glutaraldehyde in Micro-Cide" 28 HLD working solution. The indicator pad is impregnated with an indicator solution that changes color from vellow to purple if the concentration of the germicide exceeds the minimum effective concentration (MEC) of the solution.
The paper pad on an unused indicator strip is yellow in color. After an immersion time (dip time) of two seconds in a Micro-Cide™ 28 HLD solution, it is read at 120 seconds to verify the glutaraldehyde concentration of >1.8%. At 120 seconds the indicator strip will exhibit a stable uniform purple color if the concentration of glutaraldehyde is >2.1%. The strip will appear yellow or patchy yellow/purple if the solution has ≤1.8% glutaraldehyde, signaling to the customer that the solution must be replaced.
The provided text describes the acceptance criteria and the study that proves the device, the Micro-MEC 1.8% Glutaraldehyde Monitor Strip, meets these criteria.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance | • Minimum 80% pass results when tested with 2.1% glutaraldehyde Micro-Cide™ 28 HLD solution | |
| • 100% fail results with 1.8% glutaraldehyde Micro-Cide™ 28 HLD solution | Pass | |
| Specificity | Incomplete color change when exposed to tap water only | Pass |
| Contaminants | Meets performance specifications in the presence of organic and inorganic contaminants in the test solution | Pass |
| Exposure to aggressive chemicals | Meets performance specifications after exposure to aggressive chemicals. | Pass |
| Blind study testing | Meets performance specifications with inexperienced users | Pass |
| Shelf life | Meets performance specifications at each time point after storage in different environments | Pass |
| In-use (open bottle) | Meets performance specifications at each time point after storage in different environments | Pass |
| Functional stability | Meets performance specifications at each time point after storage outside bottle | Pass |
2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test in the "Performance Test Summary" (Table 5-2). It only indicates "Pass" for each criterion. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for any of the performance tests. For the "Blind study testing," it mentions performance specifications being met "with inexperienced users," implying that a human element was involved in observing results but not necessarily in establishing a ground truth by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the test set.
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
An MRMC comparative effectiveness study was not conducted. This is a chemical indicator device, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the context of this device. The device is a chemical indicator strip, which inherently produces a physical color change that is interpreted by a human user. It is not an algorithm that functions purely in a standalone digital environment. The "Blind study testing" indicates human interpretation is part of the intended use.
7. The type of ground truth used (expert consensus, pathology, outcome data, etc.)
The ground truth used for the performance evaluation appears to be the known glutaraldehyde concentrations of the Micro-Cide™ 28 HLD solutions (specifically 2.1% and 1.8%). For other tests like specificity, contaminants, and aggressive chemicals, the ground truth would be the known presence or absence of these factors and their expected impact on the indicator's performance.
8. The sample size for the training set
This concept is not applicable to a chemical indicator strip. The device operates based on a chemical reaction, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
§ 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).