(151 days)
The STERRAD® Chemical Indicator Strip is a Class 1 Process Indicator per ISO 11140-1 (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD®100NX™ | Flex |
| EXPRESS | |
STERRAD® Chemical Indicator Strip is a through-put process indicator strip to be used with STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.
STERRAD® Chemical Indicator Strip functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The yellow (or lighter) chemical indicator bar indicates that the load has been exposed to hydrogen peroxide.
The provided text describes the STERRAD® Chemical Indicator Strip, a Class 1 Process Indicator, and its performance testing. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for color change or stability). Instead, it uses qualitative "Passed" for its performance studies. The implied acceptance criteria are that the device performs as a through-put process indicator by responding as expected to hydrogen peroxide exposure, maintains color stability, has an adequate shelf life, and is biocompatible.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Chemical Indicator functions as a through-put process indicator by responding as expected to hydrogen peroxide exposure. | Passed |
| End Point / Post Processing Color Stability is maintained. | Passed |
| Shelf life is adequate. | Passed |
| Device is biocompatible. | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the "Performance testing" or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Performance testing was conducted to demonstrate the functionality of Chemical Indicator Strip in the STERRAD® 100NX™ EXPRESS Cycle."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a chemical indicator, the ground truth (successful sterilization exposure) is typically established by physical/chemical parameters of the sterilizer rather than expert human interpretation of the indicator itself as the primary ground truth. The indicator's role is to display that ground truth.
4. Adjudication method for the test set
This information is not provided in the document.
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
An MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, there is no AI assistance involved or effect size to report.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a chemical indicator that changes color; it does not involve algorithms or human-in-the-loop performance in the context of an AI-driven system. Its "standalone" performance is its ability to change color as expected when exposed to hydrogen peroxide.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for chemical indicators like the STERRAD® Chemical Indicator Strip is the physical/chemical exposure to the sterilizing agent (hydrogen peroxide) under defined conditions within the STERRAD® Sterilization Systems. The indicator's color change is a response to this ground truth. The document implies this by stating the indicator "responds as expected to hydrogen peroxide exposure."
8. The sample size for the training set
This information is not applicable and not provided. Chemical indicators are typically developed and validated through chemical formulation and engineering, not through machine learning training sets.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As mentioned, chemical indicators do not use training sets in the machine learning sense. The "ground truth" for their development would be the known successful exposure to sterilant conditions.
§ 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).