(57 days)
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.
§ 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).