(61 days)
The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.
The device is a qualitative, single use, reagent chemical indicator made up of a 0.2-inch x 0.2-inch indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration established for RAPICIDE™ PA High-Level Disinfectant. The indicator pad is affixed to one end of a 3.25-inch by 0.2-inch white plastic handle.
Here's an analysis of the acceptance criteria and study information based on the provided FDA 510(k) Clearance Letter for DISINTEK™ PA Test Strips:
Acceptance Criteria and Device Performance for DISINTEK™ PA Test Strips
1. Table of Acceptance Criteria and Reported Device Performance
| Study Parameter | Acceptance Criteria (Implicit from "Met Acceptance Criteria") | Reported Device Performance |
|---|---|---|
| Dynamic Range | Negative response at concentrations at or below MRC (850 ppm PAA), positive responses at higher concentrations. | 100% FAIL results at and below the 850 ppm PAA (MRC) and PASS results above the MRC at both 30°C and 20°C. |
| Instructions for Use Validation | Negative response at concentrations at or below MRC (850 ppm PAA), positive responses at higher concentrations, when used according to specified dip time (1-2 seconds) and sideblot time (25-30 seconds). | 100% FAIL results at and below the MRC and PASS results above the MRC with a 1-2 second dip time and a sideblot time at 25 seconds + 5 seconds for 30°C solutions and 30 seconds + 5 seconds for 20°C solutions. |
| Closed Bottle Shelf-Life Stability | Acceptable performance (100% FAIL at/below MRC, 100% PASS above MRC) for minimum claimed shelf-life (18 months) at specified storage conditions (≥ 10°C and up to 32°C). | Acceptable performance out to a minimum of 18 months shelf-life from ≥ 10°C storage up to 32°C, with 100% FAIL results at and below the MRC and PASS results above the MRC. (Data collection ongoing for extended shelf-life). |
| Open Bottle Use-Life Stability | Acceptable performance (100% FAIL at/below MRC, 100% PASS above MRC) for minimum claimed open bottle use-life (18 months) at specified storage conditions (constant high humidity, repeated openings). | Acceptable performance out to a minimum of 18 months open bottle use-life with 100% FAIL results at and below the MRC and PASS results above the MRC. (Data collection ongoing for extended open bottle use-life). |
| Comparative Sensitivity and Specificity | 100% comparative sensitivity and 100% comparative specificity against the predicate device. | Comparative sensitivity of 100% and comparative specificity of 100% was found for the DISINTEK PA test strips at both 30°C and 20°C. |
| Analytic Specificity – Bioburden | Acceptable performance (100% FAIL at/below MRC, 100% PASS above MRC) in the presence of bioburden (fetal bovine serum and hard water). | 100% FAIL results at and below the MRC and 100% PASS results above the MRC in the presence of fetal bovine serum and hard water. |
| Analytic Specificity – Other Disinfectants | Test strip yields PASS results when exposed to other peracetic acid disinfectants at their use concentrations. | Test strip yielded PASS results using these disinfectants. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes (e.g., number of test strips, unique disinfectant solutions tested, or replicates) used for each test set within the "Dynamic Range," "Instructions for Use Validation," "Closed Bottle Shelf-Life Stability," "Open Bottle Use-Life Stability," "Analytic Specificity – Bioburden," or "Analytic Specificity – Other Disinfectants" studies.
For Comparative Sensitivity and Specificity, the document also does not specify the numerical sample size.
Data Provenance: The studies were conducted by Serim Research Corporation themselves, implying the data is generated internally from their own testing facilities. The data appears to be prospective, as it describes the testing performed on the new DISINTEK™ PA Test Strips to demonstrate their performance against defined criteria. No information regarding country of origin of the data beyond "Serim Research Corporation" is provided, but as an FDA submission, the testing would likely adhere to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For chemical indicators like this, "ground truth" typically refers to the analytically determined concentration of PAA in the test solutions. This would be established by validated chemical testing methods (e.g., titration or spectroscopy) rather than expert consensus on visual interpretation. The document implies that the "ground truth" for FAIL/PASS results is based on a known PAA concentration (below/at 850 ppm MRC as FAIL, above as PASS), which would be determined analytically.
4. Adjudication Method for the Test Set
The document describes chemical indicator functionality (color change) and the interpretation of those changes (PASS/FAIL based on visual comparison to color blocks or a "solid black color" for the predicate). There is no indication of an adjudication method involving multiple human readers for interpreting the results of the DISINTEK™ PA Test Strips. The expectation is that the visual interpretation by a single user, following the provided instructions and color chart, is sufficient.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is usually conducted for imaging diagnostics or devices where human interpretation directly impacts effectiveness and can be improved by AI assistance. This device is a chemical indicator with a direct visual interpretation, not a diagnostic imaging AI system.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies described are essentially standalone in terms of the device's chemical performance. The studies evaluate the chemical indicator's ability to accurately reflect the PAA concentration, independent of human variability in reading.
However, the "Instructions for Use Validation" section does implicitly involve human interaction, as it validates the device when used as directed by a human with a specific dip and read time. The "performance" being measured (100% FAIL below MRC, 100% PASS above MRC) is the device's inherent chemical reaction, and the human's role is to correctly perform the test and interpret the color chart. So, while it's not an algorithm only in the AI sense, the core data is about the chemical functionality.
7. Type of Ground Truth Used
The ground truth used is based on analytically determined peracetic acid (PAA) concentrations in the RAPICIDE™ PA HLD solutions. Solutions were prepared with known concentrations below, at, and above the 850 ppm PAA Minimum Recommended Concentration (MRC). The "FAIL" result would be correlated with PAA concentrations ≤ 850 ppm, and the "PASS" result with PAA concentrations > 850 ppm.
8. Sample Size for the Training Set
This information is not applicable/not provided. The DISINTEK™ PA Test Strips are a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
§ 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).