(239 days)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® I Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles),
The 3MTM AttestTM Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.
This document describes regulatory approval for a Biological Indicator (a type of sterilization process indicator) and as such does not contain information on an AI/ML device. Therefore, it is impossible to answer the questions as formulated because the provided text is about a hardware device, not software/AI.
However, based on the provided text, here's a breakdown of the acceptance criteria and study that demonstrates the device meets these criteria for the 3M™ Attest™ Rapid Readout Biological Indicator 1295:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full Cycle Performance | Verify performance in each of the full cycles in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) sterilizer. | All biological indicators display a negative fluorescent and negative growth response. | Pass |
| Fractional Cycle Performance | Verify performance in fractional cycles for each of the cycles within the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles). | All biological indicators display a negative fluorescent and negative growth response. | Pass |
| Chemical Indicator (CI) Color Change | Demonstrate the color change of the CI when exposed to the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles). | Color change from blue toward pink. | Pass |
2. Sample size used for the test set and data provenance:
The document does not specify the exact sample sizes (number of biological indicators) used for each test. The study was a nonclinical performance test conducted to demonstrate performance in a newly claimed sterilizer and its cycles. As such, the provenance is likely from laboratory testing rather than human clinical data (e.g., country of origin, retrospective/prospective). While not explicitly stated, such tests are typically conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a biological indicator for sterilization processes. Its performance is measured by biological and chemical responses (fluorescence, growth, color change), not by human interpretation or diagnosis requiring expert ground truth.
4. Adjudication method for the test set:
This information is not applicable for the same reason as point 3. The outcomes are objective measurements of biological and chemical 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:
This information is not applicable as the device is a biological indicator for sterilization processes, not an AI/ML diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a biological indicator, not an algorithm or AI. Its "performance" is inherently "standalone" in the sense that it reacts biologically/chemically to sterilization conditions, and then the auto-reader interprets that reaction. There isn't a human-in-the-loop interpretation phase in the same way there would be for an AI diagnostic.
7. The type of ground truth used:
The ground truth is based on the biological viability of Geobacillus stearothermophilus spores and the chemical reaction of the indicator ink.
- For Full Cycle and Fractional Cycle Performance: The ground truth is the presence or absence of spore growth, determined by fluorescence and growth response. A "negative" result in a properly sterilized cycle indicates successful killing of spores, which is the desired outcome.
- For Chemical Indicator Color Change: The ground truth is the expected color change of the indicator upon exposure to hydrogen peroxide.
8. The sample size for the training set:
This information is not applicable as the device is a biological indicator and not an AI/ML algorithm that requires a training set. The device itself is designed and validated; it does not "learn" from data.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a "training set" or "ground truth for a training set" in the context of机器学习. Its performance is based on its inherent biological and chemical properties, validated through laboratory testing as detailed in point 7.
§ 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).