(159 days)
The STERIS STEAM n is a process indicator that undergoes a visual color change from a pink to copper color when exposed to the following steam sterilization cycle parameters:
- 121℃ (250°F), 30 min, steam sterilization gravity cycle ●
- . 132°C (270°F), 15 min, steam sterilization gravity cycle
- 135℃ (275ºF), 10 min, steam sterilization gravity cycle ●
- 132°C (270°F), 4 min, steam sterilization dynamic air removal cycle .
- 135°C (275ºF), 3 min, steam sterilization dynamic air removal cycle .
The proposed STERIS STEAM n is composed of a single ink printed on polyethylene terephthalate. The indicator inks change from pink to copper color when exposed to temperature ranges of 121℃ to 135℃ (250ºF to 275ºF).
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard ANSI/AAMI ISO 11140-1:2005 for Class 1 Indicators) | Reported Device Performance (STERIS STEAM π) |
|---|---|
| Change from pink to copper color when exposed to specified steam sterilization cycle parameters | Device changes from pink to copper color when exposed to the specified parameters. |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for performance testing (test set) or the data provenance (country of origin, retrospective/prospective). It only mentions that "Performance testing was conducted to verify that the proposed STERIS STEAM π meets the requirements...".
3. Number of Experts and Qualifications:
Not applicable. The ground truth was established by physical/chemical changes measured against a standard, not by expert review.
4. Adjudication Method:
Not applicable. The ground truth was established by physical/chemical changes measured against a standard, not by human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a chemical indicator that undergoes a visual color change, not a diagnostic imaging device requiring human interpretation alongside AI.
6. Standalone Performance (Algorithm Only):
Yes, a standalone performance test was done. The device's performance was evaluated based on the visual color change from pink to copper when exposed to specific steam sterilization cycle parameters. This is an objective, standalone assessment of the indicator's function.
7. Type of Ground Truth Used:
The ground truth used was based on meeting the requirements for process [Class 1] indicators as defined in ANSI/AAMI ISO 11140-1:2005. This involves physical/chemical properties and their reaction to standardized sterilization conditions, confirmed using a resistometer to ANSI/AAMI ISO 18472.
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI. As a chemical indicator, its design and performance are based on chemical formulations and physical properties rather than data-driven machine learning models requiring training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.
§ 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).