(259 days)
AN85/AN86 EO Indicators are single-use Type 1 process indicators used to distinguish between processed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1.
AN85/AN86 EO Indicators are adhesive-backed Type 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1.
AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.
The provided document describes the acceptance criteria and a study demonstrating that the AN85/AN86 EO Indicators meet these criteria.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Description from document) | Reported Device Performance (Result from document) |
|---|---|---|
| Functionality | 1) Critical parameters include temperature, time, and gas concentration at a relative humidity of 35-90%; 2) ISO 11140-1 Type 1 process indicator; 3) Indicate EO exposure in the CIER and in the Anprolene AN75 sterilizer. | Pass |
| Biocompatibility | Not direct or indirect patient-contacting devices; Non-toxic ingredients; Provides reasonable assurance for safety. | Pass |
| Endpoint Color Stability | Stable for at least 12 months at 20-25°C and 30-50% relative humidity away from direct sunlight; Stability demonstrates reasonable assurance for effectiveness. | Pass |
| Shelf Life | Maintains performance specifications throughout the shelf life of 2 years. | Pass |
2. Sample size used for the test set and data provenance
The document does not specify a distinct "test set" sample size in terms of number of actual indicators used. The testing was described as "Performance testing" characterized in a Chemical Indicator Evaluator Resistometer (CIER) and an Anprolene AN75 Ethylene Oxide Gas Sterilizer.
- Sample size: Not explicitly quantified. The document states "AN85/AN86 EO Indicators" or "subject AN85/AN86 EO Indicators" were tested, implying a sufficient number for the experiments, but a specific count is not given.
- Data provenance: Prospective. The performance testing was conducted specifically to demonstrate the safety and effectiveness of the AN85/AN86 EO Indicators for their intended use with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. This device is a chemical indicator, not a diagnostic device requiring human expert interpretation in the traditional sense for establishing ground truth. The "ground truth" for its performance is determined by its chemical reaction to ethylene oxide under controlled conditions, producing a visible color change.
4. Adjudication method for the test set
Not applicable. As noted above, the performance of a chemical indicator is based on its visible color change response to chemical exposure, rather than a subjective interpretation requiring adjudication. The "Pass" results in the summary table indicate that the indicators successfully met the predefined chemical and physical criteria for each test.
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
Not applicable. This is a chemical indicator, not an AI-powered diagnostic device. No human reader studies (MRMC or otherwise) were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a chemical indicator; there is no algorithm involved. The "standalone" performance means the indicator itself (the physical device) was tested.
7. The type of ground truth used
The ground truth for the AN85/AN86 EO Indicators is based on:
- Controlled chemical and physical exposure: The indicators are exposed to precisely defined ethylene oxide sterilization cycle parameters (temperature, time, gas concentration, humidity) in a Chemical Indicator Evaluator Resistometer (CIER) and the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
- Observable color change: The ground truth is the predictable and consistent color change from "yellow-green to blue" when exposed to these parameters, and no color change when not exposed.
- Compliance with standards: Adherence to ISO 11140-1 for Type 1 process indicators.
8. The sample size for the training set
Not applicable. This is a chemical indicator, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a chemical indicator, not a machine learning model.
§ 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).