(489 days)
The STERRAD® Chemical Indicator Strip (PN 14100) is a process indicator (ISO 11140-1:2005) 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 | |
| DUO |
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 through-put process indicator for STERRAD® Sterilization Systems. The primary function of the device is to differentiate processed from unprocessed packages by a recognizable color change from red to yellow upon exposure to hydrogen peroxide.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Chemical Indicator Functionality (response to hydrogen peroxide exposure) | Passed |
| End Point / Post Processing Color Stability | Passed |
| Shelf life | Passed (based on prior submission K103218 as design has not changed) |
| Biocompatibility | Passed |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample size used for the performance tests (Chemical Indicator Functionality, End Point / Post Processing Color Stability, and Biocompatibility). It only states that "Performance testing was conducted to demonstrate the functionality of Chemical Indicator Strip in the STERRAD® 100NX® DUO Cycle". The data provenance is not explicitly stated in terms of country of origin, however, it is a nonclinical study, likely conducted by the manufacturer, Advanced Sterilization Products, which is located in Irvine, California, USA. The studies mentioned are nonclinical, and the nature of the device (chemical indicator) suggests lab-based testing rather than clinical trials with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for a chemical indicator is determined by its physical and chemical properties and its observable color change. There's no mention of human expert evaluation for establishing the ground truth of the indicator's performance. The "ground truth" here is the confirmed exposure or non-exposure to hydrogen peroxide in a controlled sterilization cycle.
4. Adjudication method
Not applicable. Since there's no mention of human experts establishing ground truth or evaluating device performance in the context of diagnostic interpretation, there is no adjudication method described. The performance is based on objective chemical reactions and color changes.
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
Not applicable. This device is a chemical indicator strip, not an AI-powered diagnostic tool for human interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described is effectively a standalone performance evaluation of the chemical indicator strip. The device's functionality is assessed based on its inherent chemical reaction and observable color change, independent of any human interpretation or intervention beyond observing the result. The "Chemical Indicator Functionality" study directly evaluates the "algorithm-only" performance of the chemical indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the performance studies is the controlled exposure or non-exposure to hydrogen peroxide in a STERRAD® Sterilization System. For example, to test "Chemical Indicator Functionality," the strip would be subjected to a validated STERRAD® cycle, and its color change would be compared against the known outcome of that cycle (i.e., whether it was successfully exposed to hydrogen peroxide).
8. The sample size for the training set
Not applicable. This device is a chemical indicator, not a machine learning or AI model that requires a training set. Its functionality is based on a chemical reaction, not a learned algorithm.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no training set for this 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).