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510(k) Data Aggregation
(40 days)
SERIM DISINTEK OPA TEST STRIP
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.
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(57 days)
SERIM DISINTEK OPA TEST STRIP
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA 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 Cidex OPA Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
The provided text describes the Serim DISINTEK OPA Test Strips and the study conducted to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly defined by the performance of the predicate device, the Cidex OPA Solution Test Strip, and the ability to accurately indicate the OPA concentration above or below the Minimum Effective Concentration (MEC). The device's performance is reported in comparison to this predicate.
Acceptance Criteria & Reported Device Performance for Serim DISINTEK OPA Test Strips
| Acceptance Criteria (Implied) | Reported Device Performance and Comparison |
|---|---|
| Accuracy: Reliably indicate if OPA concentration is above or below the MEC of 0.3%. | The device "will reliably indicate if the OPA concentration is above or below the MEC level of 0.3% OPA." |
| Comparison to Predicate: Performance should be substantially equivalent to Cidex® OPA Solution Test Strip. | Performance was "evaluated in split samples blind studies and compared to test results obtained with Cidex OPA Solution Test Strips." |
| "The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Cidex OPA Solution Test Strips." | |
| Intended Use Equivalence: Have the same intended use as the predicate device (measuring OPA potency in Cidex OPA Solution, above/below 0.3% MEC). | "The Serim DISINTEK OPA Test Strips have the same intended use as the predicate device." |
| Safety and Effectiveness: Not raise any new safety or effectiveness issues compared to the predicate. | "The Serim DISINTEK OPA Test Strips do not raise any new safety or effectiveness issues." |
| Mechanism of Action: React with OPA to show color change based on concentration relative to MEC. | The device contains chemicals that react with OPA; a "first step involves a reaction in which 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." |
| Physical Characteristics: Test pad size allows for easy interpretation of color change. | "The test pad size of 0.4" x 0.4" allows for easy interpretation of the change in color." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "split samples blind studies" were used, but it does not specify the exact sample size used for the test set.
- Data Provenance: Not explicitly stated, but typical for device submissions in the US, the studies would likely be conducted in the country of origin of the submitter (Serim Research Corporation, Elkhart IN, USA). The study is described as performance evaluation, implying it was prospective in nature, as new data was generated using the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of "experts" in establishing ground truth in the context of human readers or medical professionals for this type of chemical indicator. The ground truth for chemical concentration is typically established by analytical chemistry methods rather than expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For a chemical indicator, "adjudication" in the sense of reconciling differing expert opinions would not typically apply. The "ground truth" for OPA concentration would be determined by quantitative chemical analysis.
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
No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device itself is a passive chemical indicator. Its performance is inherent to its chemical reaction properties. While human interpretation of the color change is necessary, the "test strip" itself acts as a "standalone" indicator in the sense that its chemical reaction and color formation occur independently of human judgment. The study evaluated the device's performance directly by comparing its indications to those of the predicate device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this chemical indicator would be the actual chemical concentration of ortho-phthalaldehyde (OPA) in the Cidex OPA Solution, determined by a validated analytical method (e.g., spectrophotometry, titration, or other quantitative chemical analysis). The device's color change is then compared against this known OPA concentration to determine its accuracy in indicating above or below the MEC of 0.3%.
8. The Sample Size for the Training Set
The document does not mention a "training set" as this device is a chemical indicator and not a machine learning or AI model. The concept of training data does not apply here.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this chemical indicator, this question is not applicable.
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