(74 days)
Raven ProTest - EO is a self-contained Biological Indicator inoculated with viable Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization cycles. Raven ProTest - EO has a validated reduced incubation time of 48 hours.
The biological indicator consists of a self-contained unit that includes bacterial spores of The bloodioal manouler concluded onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromothymol Blue acting as a pH indicator encased in a plastic vial that serves as the culture tube.
Here's an analysis of the provided text regarding the ProTest - EO Biological Indicator, structured according to your request:
Acceptance Criteria and Device Performance Study
The document describes the ProTest-EO Biological Indicator, a self-contained unit for monitoring ethylene oxide (EO) sterilization cycles. The study to prove the device meets acceptance criteria involved testing based on AAMI ST59:1999.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Resistance (to Ethylene Oxide sterilization) | Tested and demonstrated for three separate lots using three different primary spore crops. (Specific resistance values are not provided in this summary, but the claim is that it meets the standard.) |
| Spore Population (of Bacillus atrophaeus) | Tested and demonstrated for three separate lots using three different primary spore crops. (Specific population counts are not provided in this summary, but the claim is that it meets the standard.) |
| Recovery of low numbers of injured spores | Tested and demonstrated for three separate lots using three different primary spore crops. (The ability to recover injured spores is crucial for accurately detecting sterilization failures, and the device is stated to effectively do so.) |
| Reduced Incubation Period (duration for growth detection) | A validated reduced incubation period of 48 hours. |
| Overall effectiveness in monitoring routine ethylene oxide sterilization cycles (as compared to predicate device) | Demonstrated for all lots tested, indicating substantial equivalence to the legally marketed predicate device EZTest - Gas in composition, function, and ability to monitor EO sterilization cycles. Evidence of growth (color change/turbidity) within 48 hours indicates sterilization failure, assuming viable control. |
2. 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." This implies testing was conducted on a sufficient number of product units from each of these distinct lots/spore crops to establish reliability and consistency. The exact number of individual biological indicators tested within each lot is not specified in the provided summary.
- Data Provenance: Not explicitly stated, but given it's for FDA submission, it's presumed to be from the manufacturer (Raven Biological Laboratories) in the United States. The study is prospective in the sense that the testing was performed specifically to validate the claims for this device prior to its market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of device relies on a biological response (spore viability/growth) as its "ground truth" rather than expert interpretation of images or clinical data. The "ground truth" for whether sterilization failed or succeeded is determined by the presence or absence of spore growth, indicated by a color change. The AAMI ST59:1999 standard itself dictates the parameters for determining effectiveness.
4. Adjudication Method for the Test Set
- Not Applicable. As described above, the outcome is a direct biological response (color change/turbidity) as per the operational principles, not a subjective interpretation requiring adjudication among experts. The "ground truth" is a direct experimental finding of spore viability.
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 is a biological indicator, not an AI-powered diagnostic device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is effectively a standalone performance study. The device itself provides the result (color change or turbidity for growth, or no change for no growth) based on the biological reaction. Human involvement is limited to activating the device, incubating it, and observing the color change, which is a direct, objective read. There's no "algorithm" in the sense of a software-based AI, but the biological indicator system operates autonomously to indicate growth.
7. The Type of Ground Truth Used
- Experimental/Biological Ground Truth: The ground truth is the viability of the Bacillus atrophaeus spores after exposure to an ethylene oxide sterilization cycle.
- Negative Result (Sterilization achieved): No viable spores remain, thus no growth and no color change within 48 hours.
- Positive Result (Sterilization failed): Viable spores remain, leading to germination, metabolic activity, and a color change from green to yellow due to pH reduction, within 48 hours.
- A control unit (unprocessed) is run concurrently to ensure the spores are viable and the culture medium supports growth, confirming the validity of the test.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device that requires a "training set." The performance is based on the inherent biological properties of the spores and media, validated through direct experimental testing.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set was used. The ground truth for the performance study (resistance, spore population, recovery, incubation time) was established through controlled laboratory experiments, often comparing against established reference methods or standards (like AAMI ST59:1999) using known sterilization parameters and calibrated equipment to assess spore viability and growth.
§ 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).