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The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.

The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.

The test pack consists of multiple layers of paper cards with a SporView Rapid Read Biological Indicator, chemical process indicators and load record card. The load record card is used to record the detailed information from the sterilization cycle.

The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.

The provided text describes the regulatory clearance for the "SporView Rapid Read Biological Indicator SteamPlus Test Pack." The document includes a summary of non-clinical performance data, which outlines the acceptance criteria and the results of the study conducted to demonstrate the device's performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set or the country of origin of the data. It also does not specify if the data was retrospective or prospective. The "Summary of Non-Clinical Performance Data" implies prospective testing as it describes performance testing conducted to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable to a biological indicator device. Biological indicators are evaluated based on their ability to show the presence or absence of viable microorganisms after a sterilization process, not on expert interpretation of images or other subjective assessments. The "ground truth" for a biological indicator is the objective determination of microbial growth or no growth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation by multiple human readers (e.g., in medical image analysis). For a biological indicator, the outcome (growth or no growth) is an objective biological response.

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. This device is a biological indicator for sterilization monitoring, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent in its design and biological response, not in an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a biological indicator is the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is determined by observing microbial growth (or lack thereof) in a controlled incubation process. For the "complete kill" criteria, the ground truth is the absence of microbial growth, indicating a successful sterilization cycle. For resistance testing, the ground truth relates to the time/temperature exposure required to inactivate the spores.

8. The sample size for the training set

This information is not applicable. The device is a physical biological indicator, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. As stated above, the device does not involve a training set.

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The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.

The SporView Rapid Read Biological Indicator is a self-contained biological indicator designed to be used with the 3M Attest 390 auto-reader to qualify or routinely challenge dynamic-airremoval (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C). The SporView Rapid Read Biological Indicator is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap. Similar to the predicate device, 3M's 1292 Rapid Read-Out Biological Indicator cleared under 510(k)s K090569 and K926364, the subject device contains ≥ 105 viable spore population of G. stearothermophilus. It utilizes the a-glucosidase system, which is generated naturally within growing G. stearothermophilus. A successful steam sterilization cycle will result in no growth of G. stearothermophilus. A failure in the sterilization cycle creates a fluorescence change, which is detected upon incubation in the 3M 390 Attest Auto-reader. This provides an enzymatic result in 3 hours to indicate a steam sterilization process failure. The biological indicator will also detect the presence of G. stearothermophilus organism by a visual color change reaction. Biochemical activity of the orqanism will produce acid by-products that cause the media to change color after 48 hours. A visual pH color change after 48 hours also indicates a steam sterilization process failure.

This document describes the SporView Rapid Read Biological Indicator, a device designed to monitor the effectiveness of steam sterilization cycles.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for each specific test in the "Performance Characteristics Testing" section. However, the testing was conducted by Medivators in accordance with FDA Guidance on Biological Indicators to demonstrate that the device meets or exceeds acceptance criteria. The data provenance is implied to be from laboratory testing conducted by the manufacturer, Medivators (Crosstex/SPSmedical). The type of data is non-clinical performance data. There is no information regarding country of origin or whether the data is retrospective or prospective, although typically, pre-market submissions involve prospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "ground truth" for a biological indicator would be based on the known state of sterilization (e.g., whether a sterilization cycle was effective or not) and the measurable biological response of the indicator (e.g., spore growth or no growth). This is determined by the experimental setup rather than expert consensus on individual results.

4. Adjudication method for the test set:

Not applicable. The "ground truth" for the performance of a biological indicator in these types of tests is typically objective (e.g., based on known sterilization parameters and direct observation of microbial growth/killing), rather than requiring adjudication among human experts.

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 device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. The device is a biological indicator itself, which is then read by an auto-reader (3M Attest 390 Auto-Reader). The performance evaluated is the indicator's ability to accurately reflect sterilization efficacy, confirmed by its interaction with the auto-reader. There is no "algorithm only" performance reported in the sense of a software-based diagnostic.

7. The type of ground truth used:

The ground truth used for these tests is based on objective biological and physical measurements related to sterilization efficacy. This includes:

• Spore viability: Direct counts of viable spores.
• Resistance characteristics (D-value, Z-value, Survival Time): Determined by exposing the biological indicators to precisely controlled steam sterilization conditions and observing the killing kinetics of the spores.
• Growth promotion: Observing the ability of the media to support the growth of G. stearothermophilus.
• Fractional and full cycle inactivation: Observing partial kill after a fractional cycle and complete inactivation after a full cycle in a marketed sterilizer.

8. The sample size for the training set:

Not applicable as this is not an AI/machine learning device that requires a training set. The "training set" concept is traditionally associated with statistical models or machine learning algorithms that learn from data.

9. How the ground truth for the training set was established:
Not applicable for the reasons stated in point 8.

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