(76 days)
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.
The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
This document describes the Raven ProTest - Steam Biological Indicator, a self-contained biological indicator designed to monitor the efficacy of steam sterilization cycles.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance is described in the context of validating its labeled claims and characteristics during testing. The primary performance goal is to demonstrate effective monitoring of steam sterilization cycles.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with steam sterilization cycles (121℃ to 135℃) | "Testing was performed in accordance with AAMI ST59:1999 to validate the labeled claims and performance characteristics of ProTest - Steam... monitoring routine steam sterilization cycles has been demonstrated." The device is intended for "monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles)." |
| Reliable detection of spore growth/no growth | "Evidence of growth by color change and/or turbidity within 24 hours should be interpreted as a sterilization failure... provided signs of growth are present in the control unit." This indicates the device successfully shows growth when sterilization fails and conversely, no growth when it succeeds. |
| Reduced Incubation Time | "Raven ProTest - Steam has a validated reduced incubation time of 24 hours." |
| Resistance Characteristics | "Three separate lots of product manufactured from three different primary spore crops were tested for resistance..." (Details of the resistance value are not provided, but it implies meeting a standard). |
| Spore Population | "...spore population, recovery of low numbers of injured spores, were tested..." (Details of the population count are not provided, but it implies meeting a standard). |
Study Information:
-
Sample size used for the test set and data provenance:
- Sample Size: "Three separate lots of product manufactured from three different primary spore crops" were tested. While the exact number of individual biological indicators within these lots isn't specified, it indicates an evaluation across different production batches.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was "performed in accordance with AAMI ST59:1999," which is a US standard. The study seems to be internal validation by the manufacturer, Raven Biological Laboratories. The study is retrospective in the sense that it evaluates the manufactured product against established standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of biological indicator study does not typically involve human experts establishing ground truth in the way a diagnostic imaging study would. The ground truth for biological indicators is established by the known conditions of the steam sterilization cycle (e.g., fully successful sterilization vs. partial/failed sterilization conditions). The "ground truth" of whether spores survived or not is determined by their biological response (growth/no growth) and color change.
-
Adjudication method for the test set:
- Not applicable as the "ground truth" is determined by the biological reaction of the spores themselves and their nutrient media, rather than expert interpretation of complex data. The "adjudication" is essentially the observation of a color change or turbidity.
-
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 biological indicator, not an AI-powered diagnostic tool. There are no "human readers" interpreting images or complex data in the sense of an MRMC study.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its biological and chemical components.
-
The type of ground truth used:
- Biological Response: The ground truth is established by the biological viability of the Geobacillus stearothermophilus spores under different sterilization conditions. A successful sterilization cycle should render the spores non-viable, leading to no growth and no color change in the media. An unsuccessful cycle should leave viable spores, leading to growth (turbidity) and a color change (purple to yellow). This is a direct biological and chemical outcome.
-
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. 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).