(224 days)
The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad that has been chemically treated to detect OPA. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
The SERIM Research Corporation RAPICIDE OPA-28 Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA), the active ingredient in RAPICIDE OPA-28 Solution, is above or below its established Minimum Recommended Concentration (MRC) of 0.35%.
Here's an analysis of its acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The provided document indicates the device must reliably indicate if the OPA concentration is above or below the MRC of 0.35%.
The clinical study demonstrated that the device met these criteria through comparative performance with a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reliable indication of OPA concentration (above or below MRC of 0.35% in RAPICIDE OPA-28). | The RAPICIDE OPA-28 Test Strips were evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies. The performance was found to be substantially equivalent to the predicate device, Serim® DISINTEK™ OPA Test Strips (which measure potency in Cidex OPA solutions at the MEC and above). The study concludes that the test strip is "safe and effective in monitoring the OPA concentration in Rapicide OPA-28 Disinfectant Solution." |
2. Sample Size and Data Provenance
The document does not explicitly state the exact sample size (number of test strips or OPA solution samples) used for the blind studies.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic device, it is highly likely that the studies were prospective, conducted at the manufacturer's facilities.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications for establishing ground truth. For chemical indicators like this, the "ground truth" would likely be established through analytical chemistry methods (e.g., spectrophotometry or titration) to precisely determine the OPA concentration in the test solutions, rather than human interpretation of the strips themselves as the primary ground truth.
4. Adjudication Method
The document does not describe an adjudication method. For a qualitative chemical indicator where the "ground truth" is a defined chemical concentration, judgment calls by multiple experts with an adjudication method are typically not required. The comparison is against an analytical standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. This type of study is typically relevant for interpretative devices where human variability in reading results is a significant factor. For a chemical indicator, the reading is expected to be relatively straightforward (color change), reducing the need for such a complex reader study. The study focused on the performance of the device itself rather than human improvement with AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Performance" section explicitly states that "The performance of the RAPICIDE OPA-28 Test Strips was evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies." This evaluation determines the device's ability to accurately indicate the OPA concentration without human-in-the-loop assistance in the interpretation of the color change.
7. Type of Ground Truth Used
The ground truth used would be analytical determination of OPA concentration. The study involved evaluating the test strips in "OPA solutions of Rapicide OPA-28 at the MRC and above." This implies that the OPA concentrations in these solutions were precisely known through validated analytical chemistry methods, serving as the objective ground truth against which the test strip's performance was measured.
8. Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. This is common for chemical indicators of this type, which are typically developed based on chemical principles rather than machine learning algorithms requiring explicit training data. The development process would involve formulation and optimization of the reagents to achieve the desired color change at the target concentration.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of machine learning, there is no corresponding ground truth establishment method described. The development of the test strip would rely on chemical formulation and empirical testing against analytically prepared OPA solutions with known concentrations.
§ 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).