(87 days)
For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134℃ (273ºF) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.
The INDISTRIP Green Process Indicator for sterilization consists of a metal free indicator ink printed onto white vellum. The indicator changes color from yellow to black when exposed to steam sterilization conditions. Unprocessed indiryclife to stable for atleast 6 months when stored at 30℃ or less. The postprocessed indicator color is stable for at least 6 months after exposurer to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134°C (273°F) for 4 minutes in gravity or vacuum assisted steam sterilize cycles of. The indicator does not respond to dry heat or ethylene oxide.
Here's a breakdown of the acceptance criteria and study information for the Indistrip Green device based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Indistrip Green (Based on AAMI ANSI ISO 11140-1:2005 Class 1 Process Indicators)
| Test Environment | Test Time | Test Temperature | Expected vs. Observed Performance | Acceptance Criterion | Reported Performance (Indistrip Green) |
|---|---|---|---|---|---|
| Saturated Steam | 3.0 min ± 5 s | 121 °C (+3/0 °C) | No change or markedly different | No change or a change that is markedly different from the visible color change as specified by the manufacturer | Pass |
| Saturated Steam | 10.0 min ± 5 s | 121 °C (+3/0 °C) | Visible color change | Visible color change as specified by the manufacturer | Pass |
| Saturated Steam | 0.5 min ± 5 s | 134 °C (+3/0 °C) | No change or markedly different | No change or a change that is markedly different from the visible color change as specified by the manufacturer | Pass |
| Saturated Steam | 2.0 min ± 5 s | 134 °C (+3/0 °C) | Visible color change | Visible color change as specified by the manufacturer | Pass |
| Dry Heat | 30 min ± 1 s | 140 °C (+2/0 °C) | No change or markedly different | No change or a change that is markedly different from the visible color change as specified by the manufacturer | Pass |
Note: The device's specified visible color change is from yellow to black.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes physical/chemical testing of the indicator, not a clinical study involving human patients or data in the traditional sense. Therefore, terms like "test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the same way they would be for a diagnostic imaging device.
- Test Set Description: The testing involved subjecting the Indistrip Green indicators to specific controlled conditions (temperature, time, environment) as outlined in the AAMI ANSI ISO 11140-1:2005 standard for Class 1 process indicators.
- Sample Size: The document does not explicitly state the number of individual Indistrip Green indicators tested for each condition. It reports "Pass" for each test, implying that a sufficient number was tested to demonstrate consistency and compliance.
- Data Provenance: The data is physical/chemical performance data generated under controlled laboratory conditions, likely at the manufacturer's facility or a certified testing lab. No country of origin for patient data is relevant here. The study is prospective in the sense that the tests were conducted specifically to evaluate the performance of this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This metric is not applicable to the evaluation of a chemical process indicator. Ground truth in this context is established by physical/chemical properties and adherence to recognized industry standards (AAMI ANSI ISO 11140-1:2005), not by expert consensus on interpretations of images or patient outcomes. The expected color change (yellow to black) upon sufficient exposure to sterilization conditions is a deterministic outcome.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation of a chemical indicator's color change under controlled conditions does not involve expert adjudication methods like 2+1 or 3+1. The observable color change (or lack thereof) against a predefined specification is the determinant of performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating the impact of a device (e.g., AI in medical imaging) on human reader performance, typically in diagnostic tasks. This is not relevant for a chemical process indicator.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a standalone chemical indicator; it functions without human-in-the-loop interaction for its primary purpose of changing color. The "performance data" presented is a standalone evaluation of the device's ability to undergo the specified color change under various conditions. There's no "algorithm" in the sense of software processing or interpretation; the indicator's chemical reaction is its "performance."
7. The Type of Ground Truth Used
The ground truth used is based on pre-defined physical/chemical performance specifications and industry standards. Specifically, the device claims to meet the requirements defined in AAMI ANSI ISO 11140-1:2005 for Class 1 Process Indicators. The "ground truth" for each test condition is whether the indicator exhibited the expected color change (or lack thereof) as defined by these standards when exposed to particular temperature and time parameters in a saturated steam or dry heat environment.
8. The Sample Size for the Training Set
Not applicable. Chemical process indicators do not typically involve "training sets" in the context of machine learning or AI. The device's performance is driven by its inherent chemical composition, which is designed and manufactured to react in a specific way.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device. The chemical formulation and manufacturing process are designed to meet the specified performance characteristics directly.
§ 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).