(216 days)
The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.
The proposed Verify® Dry Heat Label consists of indicator ink applied to a substrate using a rotary screen printing method. When exposed to dry heat in the temperature range of 160°C to 180°C the indicator ink changes color from amber to black. The indicator is not intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a dry heat process.
The provided text describes a Verify® Dry Heat Label which is a chemical indicator for dry heat sterilization. Based on the information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C. | The Verify® Dry Heat Label undergoes a visual color change from amber to black when exposed to dry heat in the temperature range of 160°C to 180°C. |
| Conformance to ANSI/AAMI ST60: Applied to Class I process indicators for dry heat sterilization. | "Albert Browne Ltd. has performed testing which demonstrates that the Verify® Dry Heat Label conforms to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization." |
| Performance in Dry Heat Sterilization Cycles: As designed in the range of 160°C to 180°C. | "Additional testing showed that the indicator performed as designed in dry heat sterilization cycles in the range of 160°C to 180°C." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance. It only states that "Albert Browne Ltd. has performed testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the device (a chemical indicator with a clear color change) suggests that expert interpretation in the traditional sense (e.g., radiologists for medical images) might not be directly applicable for its primary function. However, the interpretation of "conforms to ANSI/AAMI ST60" would imply expert knowledge of the standard.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned. This type of study is more common for diagnostic devices where human interpretation is a critical variable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical chemical indicator, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is inherent in its chemical reaction.
7. The Type of Ground Truth Used
The ground truth used for this device's performance is based on:
- Physical/Chemical Reaction: The color change of the indicator ink when exposed to specific temperatures.
- Conformance to Industry Standards: Meeting the requirements outlined in ANSI/AAMI ST60 for Class I process indicators for dry heat sterilization.
- Empirical Observation: The visual change from amber to black.
8. The Sample Size for the Training Set
This device is a chemical indicator, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable.
§ 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).