(290 days)
The Browne MVI Steam Indicator is a sterilization process indicator designed to indicate, through a visible color change, when the device has been exposed to a steam sterilization process.
The Browne MVI Steam Indicator is a process indicator designed to indicate, through a white to purple color change, when the device has been exposed to a steam sterilization process in a working range of 121-134°C.
The Browne Steam Indicator is a paper strip with indicator ink pads on each end which is used to monitor steam sterilization cycles. The indicator ink changes color from white to purple through a pink intermediate in a steam autoclave working at 121-134°C.
The Browne MVI Steam Indicator consists of a paper strip with chemical indicator ink pads located on each end. The device is designed to monitor steam sterilization processes in gravity and vacuum-assisted steam autoclaves with a working range of 121-134°C. The color change in both devices is produced by a temperaturedependent chemical reaction.
Here's an analysis of the acceptance criteria and study information for the Browne MVI Steam Indicator, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Indicate, through a visible color change (white to purple with a pink intermediate), when the device has been exposed to a steam sterilization process. | Strips changed color from white to purple with a pink intermediate. |
| Monitor steam sterilization processes in gravity and vacuum-assisted steam autoclaves with a working range of 121-134°C. | Device can be used for the confirmation of exposure to a steam sterilization process in a steam autoclave with a working range of 121-134°C. |
| Time required for complete development of an end point response at 121°C. | ≥7 minutes at 121°C. |
| Time required for complete development of an end point response at 134°C. | ≥3 minutes at 134°C. |
Study Details
The provided text describes performance testing, but it does not detail a study in the sense of a formal clinical trial with human subjects or a comparison to an established gold standard in a real-world setting. Instead, it describes laboratory testing of the device's functional performance.
Here's a breakdown of the requested information based on the available text:
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of Browne MVI Steam Indicator strips (sample size) used for testing. It states "Testing was conducted to evaluate the performance of the strips..." implying multiple strips were tested.
- Data Provenance: The testing was conducted "in a BIER vessel/prototype which conforms to the performance requirements for BIER/Steam vessels described in ANSI/AAMI ST45-1992." This indicates a controlled laboratory environment, not a retrospective or prospective study from a specific country of origin in a clinical setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "ground truth" here is the observed color change of the indicator strips in response to defined steam sterilization conditions. The assessment of color change is a direct observation of the device's function, not an interpretation by experts in the typical sense of medical imaging or diagnostic devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a chemical indicator (a direct color change), a formal adjudication method like those used for expert consensus on medical images is unlikely to have been applied. The "ground truth" is likely the direct observation of the color change itself under controlled conditions.
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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:
- No. An MRMC comparative effectiveness study was not done. This device is a passive chemical indicator, not an AI-powered diagnostic tool requiring human interpretation and comparison with human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance testing described is for the device (chemical indicator) alone, without human intervention or interpretation beyond observing the color change. There is no algorithm involved; it's a chemical reaction.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is the physical state of the steam sterilization process (i.e., exposure to specific temperatures and times) and the observed physical change of the device (color change from white to purple/pink). It's based on the intrinsic chemical reaction of the indicator.
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The sample size for the training set:
- This concept is not applicable. The Browne MVI Steam Indicator is a chemical indicator, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- This concept is not applicable, as 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).