(288 days)
Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes.
The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.
The 3M Attest™ 1496V Super Rapid Readout Steam and 41482V Super Rapid 5 Steam-Plus Challenge Packs are specifically designed to qualify or routinely challenge 270°F (132°C) and 275°F (135°C) dynamic-air-removal (pre-vacuum) steam sterilization cycles in healthcare facilities. The packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The packs are overwrapped and secured with a label. The Challenge Packs and the predicate device all contain a biological indicator. The 41482V Challenge Pack and the predicate device also contain a SteriGage™ chemical integrator. Each Challenge Pack has a chemical process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the 3M Attest™ 1496V and 41482V Super Rapid Readout Steam Challenge Packs:
Acceptance Criteria and Device Performance
| Challenge Pack Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance of the Challenge Pack as compared to AAMI towel pack | Challenge Pack is at least as resistant as the biological indicator AAMI towel pack recommended by ANSI/AAMI ST-79: 2010, A1:2010 and A2:2011 | Pass |
| Resistance of the Pack as compared to the Biological Indicator or Chemical Integrator alone | Pack provides a greater resistance than the Biological Indicator or Chemical Integrator alone | Pass |
| Chemical Process Indicator | Chemical Process Indicator on the Challenge Pack label changes from yellow to brown or darker upon exposure to steam | Pass |
| Characteristics of Biological Indicator | Challenge Packs contain a biological indicator with Geobacillus stearothermophilus (ATCCTM 7953) at a population ≥ 10^6 spores that complies with FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007, ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3: 2006/(R)2010 | Pass |
| Characteristics of Chemical Integrator (41482V only) | Challenge Packs contain a chemical integrator that complies with FDA's Guidance for Chemical Indicators FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003 and ANSI/AAMI/ISO 11140-1:2005/(R)2010. Class 5 | Pass |
Study Details:
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: "Multiple lots of 3M Attest™ Super Rapid Challenge Packs were prepared containing multiple lots of 1492V Super Rapid BIs and SteriGage™ chemical integrators." While "multiple lots" indicates more than one, a specific numerical sample size (e.g., number of individual challenge packs tested, number of BIs, number of CIs) is not provided.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be retrospective in the sense that it's based on pre-market testing to demonstrate compliance with standards, rather than a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This type of device (biological and chemical indicators for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging device would. The "ground truth" is established by adherence to predefined scientific and regulatory standards (e.g., spore population, color changes, resistance compared to AAMI towel pack). Therefore, information on "experts" for ground truth in this context is not applicable and not provided.
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Adjudication method for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading). For this device, the "adjudication" is based on objective measurements and comparison against established scientific and regulatory standards. Therefore, an adjudication method in this sense is not applicable and not provided.
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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 type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, potentially with AI assistance. The 3M Attest™ Challenge Packs are sterilization indicators, and their function relies on chemical and biological reactions, not human interpretation in the context of reading an image or clinical case.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone performance assessment of the physical device (challenge pack, biological indicator, chemical integrator). The "algorithm" in this context refers to the biological and chemical processes the device undergoes and the auto-reader's ability to detect the fluorescent result. The testing described focuses on the inherent performance of the device without a human-in-the-loop interacting with an AI system. The 3M Attest™ 490 Auto-reader is a key component for interpreting the fluorescent result, so it operates as a "standalone" system in conjunction with the indicators.
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The type of ground truth used:
- The ground truth is established by adherence to predefined scientific and regulatory standards. These standards dictate:
- The minimum resistance required (compared to AAMI towel pack).
- The expected resistance relative to its components (BI or CI alone).
- The observable color change of the chemical process indicator.
- The characteristics of the biological indicator (specific organism, spore population, compliance with ISO standards).
- The characteristics of the chemical integrator (compliance with FDA guidance and ISO standards, Class 5).
- The ground truth is established by adherence to predefined scientific and regulatory standards. These standards dictate:
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The sample size for the training set:
- This document describes performance testing for a finished medical device. It is not a machine learning model, so there is no concept of a "training set" in the traditional AI sense. The development and manufacturing of such devices involve extensive internal testing and quality control, but these are not referred to as "training sets."
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How the ground truth for the training set was established:
- As there is no training set mentioned or applicable for this type of device, this question is not applicable.
§ 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).