(156 days)
The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.
The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square indicator pad that has been chemically treated to detect GTA. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
Here's a breakdown of the acceptance criteria and study information for the Serim® D-CIDE GTA 1.5% Test Strip, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution. | The performance of the Serim D-CIDE GTA 1.5% Test Strips was evaluated in split samples blind studies and compared to test results obtained with 3M Comply Cold Sterilog 1.5% GTA Test Strips. The performance of the Serim D-CIDE GTA 1.5% Test Strips is substantially equivalent to the predicate device, 3M Comply Cold Sterilog 1.5% GTA Test Strips, for determining if glutaraldehyde concentration is above or at/below the MEC of 1.5%. Specifically, when glutaraldehyde concentration is above 1.5% (MEC), enough base is produced to result in an irreversible and distinct purple color change on the indicator pad. When glutaraldehyde concentration is at or approaching the MEC level, the indicator pad will display distinct white areas. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided document. The document mentions "split samples blind studies" but does not give a numeric count of samples.
- Data Provenance: Not explicitly stated. There's no mention of country of origin or whether the data was retrospective or prospective.
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 of establishing ground truth relies on the chemical reaction and visual color change of the test strip, and comparison to a predicate device, rather than expert interpretation of complex data.
4. Adjudication Method for the Test Set:
- This information is not provided as the ground truth appears to be based on the chemical reaction and visual color change, not on subjective assessment that would require adjudication. The study involved "blind studies" and comparison to a predicate device.
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. Its performance is based on a chemical reaction producing a visual color change, not on human interpretation that could be augmented by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- Yes, in essence, a standalone performance was done. The device itself, a chemical test strip, operates independently to produce a visual result based on the glutaraldehyde concentration. The "performance" described is the inherent function of the test strip (a chemical reaction) and its visual output, without a human "in the loop" for interpretation beyond simply observing the color change.
7. The Type of Ground Truth Used:
- The ground truth is established by the chemical concentration of glutaraldehyde in the solutions being tested. The device is designed to visually indicate whether this concentration is above or at/below the MEC of 1.5%, based on a specific chemical reaction. The validation relies on comparing this visual indication against the known concentration of glutaraldehyde and against the performance of a predicate device.
8. The Sample Size for the Training Set:
- This information is not provided in the document. The device is a chemical indicator, not a machine learning algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable/provided. As mentioned, the device is a chemical indicator. Its development and validation likely involved chemical formulations and testing to ensure the desired color change reaction at specific glutaraldehyde concentrations, rather than a "training set" with established ground truth as understood in AI/machine learning contexts.
§ 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).