(40 days)
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Metricidc OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Metricide OPA Plus Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA) in Metricide OPA Plus Solution is above or below its minimum effective concentration (MEC) of 0.3%.
Here's an analysis of the provided information regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device, specifically the Metricide OPA Plus Solution Test Strip, by accurately indicating OPA concentration relative to the 0.3% MEC.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Reliable indication of OPA concentration above 0.3% MEC (green color formation). | The device reliably indicates if the OPA concentration is above or below the MEC level of 0.3% OPA. OPA levels above 0.3% react with a second chemical to form a colored compound, resulting in a green color. |
| Reliable indication of OPA concentration below 0.3% MEC (colorless product formation). | The device reliably indicates if the OPA concentration is above or below the MEC level of 0.3% OPA. A concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product (implying no green color if below MEC). |
| Performance substantially equivalent to the predicate device (Metricide OPA Plus Solution Test Strips). | The performance of the Serim DISINTEK OPA Test Strips was evaluated in split samples blind studies and compared to test results obtained with Metricide OPA Plus Solution Test Strips. The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Metricide OPA Plus Solution Test Strips. |
| Does not raise any new safety or effectiveness issues compared to the predicate device. | The Serim DISINTEK OPA Test Strips do not raise any new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size used for the test set. It mentions "split samples blind studies" but provides no specific numbers for the samples tested.
- Data Provenance: Not explicitly stated. Given the context of a 510(k) submission to the US FDA, it is highly likely that the data was generated in the United States, but this is not explicitly confirmed. The studies appear to be prospective in nature, as they involve actively evaluating the performance of the new device in comparison to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The method for establishing ground truth for the test set is implied by the comparison to a predicate device and chemical reactions, rather than expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. The nature of a chemical indicator test, where the result is a color change based on a chemical reaction, typically does not involve human adjudication in the same way an imaging diagnostic might. The output is a direct chemical reading.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) where the AI assists in the reading process. The Serim® DISINTEK™ OPA Test Strip is a chemical indicator that produces a direct, objective result (color change), not a complex interpretation task for human readers.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Was it done? Yes, in essence, the performance evaluation described is a standalone study of the device. The "split samples blind studies" evaluated the performance of the Serim DISINTEK OPA Test Strips on their own merits and then compared the results directly to the predicate device. The device's mechanism is a chemical reaction leading to a direct color change, which is an inherent "algorithm" of the test strip itself. The outcome is not subject to human interpretation in the same way as an imaging algorithm might be reviewed by a human.
7. Type of Ground Truth Used
The ground truth used is based on chemical concentration levels of OPA relative to the 0.3% MEC. This is established by:
- The known chemical properties and reactions designed into the test strip.
- Comparison to the performance of an already legally marketed and accepted predicate device (Metricide OPA Plus Solution Test Strips) which also relies on chemical determination of OPA concentration.
- The chemical principle: "A chemical at a concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color." This defines the objective ground truth against which the strip's response is measured.
8. Sample Size for the Training Set
This information is not provided. As this is a chemical indicator and not a machine learning or AI-driven device in the modern sense (which typically requires large training sets), the concept of a "training set" for an algorithm isn't directly applicable in the same way. The device's "training" would be through its chemical formulation and manufacturing tolerances, which are established through lab development and quality control, not typically a large data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of a "training set" for a traditional algorithm. The "ground truth" for the device's design and chemical formulation would have been established through:
- Understanding the specific chemical reactions of OPA.
- Titration or analytical chemistry methods to precisely determine OPA concentrations at and around the 0.3% MEC.
- Empirical testing during product development to refine the chemical composition of the test strip to achieve the desired sensitivity and specificity for the color change at the MEC threshold.
§ 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).