(221 days)
The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- 270°F (132°C), 10 min. flash gravity steam sterilization .
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .
The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color.
Here's a breakdown of the acceptance criteria and the study that proves the Verify Flash Integrator device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Verify Flash Integrator
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ANSI/AAMI ST60-1996 Class 5 integrating indicators) | Reported Device Performance |
|---|---|
| Color change from yellow to blue/purple | Device changes color from yellow to blue/purple |
| Response to 270°F (132°C), 10 min. flash gravity steam sterilization | Performed as expected |
| Response to 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization | Performed as expected |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of individual integrators tested. However, it indicates simulated use testing was conducted.
- Sample Size: Not explicitly stated as a number of individual units.
- Data Provenance: The testing was "simulated use testing", implying a laboratory or controlled environment rather than real-world patient data. The country of origin of the device manufacturer is the United Kingdom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a chemical indicator, "ground truth" would likely be established by objective measurements of temperature and exposure time, rather than expert interpretation of the indicator itself. The performance standard (ANSI/AAMI ST60-1996) would define the parameters for acceptance.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used for studies involving human interpretation (e.g., image analysis by radiologists) where discrepancies need to be resolved. For a chemical integrator that changes color, the outcome is objective (either it changes color appropriately or it doesn't) and would be assessed against the predefined physical parameters, not through expert consensus on its interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance improves with AI assistance compared to without it, which is not relevant for a standalone chemical sterility indicator.
6. If a Standalone (i.e. Algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was effectively done. The "device" in this context (Verify Flash Integrator) operates entirely by itself (changes color based on conditions). The performance testing described is inherently a standalone assessment of the device's ability to meet its specifications without human interpretation as part of its functionality. Human observation is required to read the result, but the device's performance isn't dependent on human assistance during its operational phase.
7. The Type of Ground Truth Used
The ground truth used was based on objective physical parameters and established standards:
- The specified temperature (132°C/270°F)
- The specified exposure times (10 min. or 4 min.)
- The requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. Chemical indicators are physical devices, not machine learning algorithms, and thus do not have "training sets" in the conventional sense. The design and formulation of the indicator would be developed and refined through R&D, but this isn't reported as a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable because there is no "training set" for this type of device. The "ground truth" for the device's development would have been established through chemical and physical principles and laboratory testing to achieve the desired color-change response to specific sterilization parameters.
§ 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).