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The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.

When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

The provided document, a 510(k) premarket notification for the VERIFY Assert Self-Contained Biological Indicator, details the device's technical characteristics and nonclinical testing. However, it does not describe a study involving an AI-powered medical device or human readers. Therefore, much of the requested information cannot be extracted from this specific document.

Here's the information that can be extracted or inferred based on the document's content, formatted as requested:

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 specify the sample size for the "Simulated Use" test, nor does it provide details about the data provenance (e.g., country of origin, retrospective/prospective). It only states that performance testing "has been completed" and is summarized.

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

Not applicable. This device is a biological indicator for sterilization, not an imaging or diagnostic device requiring expert review for ground truth. The "ground truth" for this device's function is the biological outcome (growth or no growth of the biological indicator) after exposure to sterilization conditions.

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

Not applicable. There's no human interpretation or adjudication described for the biological indicator's performance. The outcome is a direct biological observation (fluorescence, indicating growth, or lack thereof).

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 document describes a biological indicator, not an AI-powered device or a study involving 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. Its operation involves a "VERIFY Incubator for Assert Self-Contained Biological Indicator" which detects a fluorescent result, suggesting an automated readout. However, this is not an "algorithm only" performance in the context of AI without human-in-the-loop diagnosis or interpretation. The device itself is the indicator, and the incubator provides an automated reading of its state.

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

The ground truth for this device's performance is the biological outcome: inactivation (no growth) of the Geobacillus stearothermophilus spores after exposure to sterilization conditions, or growth when not adequately sterilized. This is determined by observing fluorescence, which indicates enzymatic activity from viable spores.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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The VERIFY™ Assert™ STEAM Process Challenge Device (PCD) is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.

The validated steam sterilization cycles include:

• 270°F (132°C) 4-minute dynamic air removal
• 275°F (135°C) 3-minute dynamic air removal

Not Found

This document is a 510(k) clearance letter for a medical device (VERIFY Assert STEAM Process Challenge Device) and an "Indications for Use" statement. It does not contain information about acceptance criteria, study details, or device performance against those criteria. Therefore, I cannot extract the requested information from this document.

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The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.

When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert Self-Contained Biolgoical Indicator in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

The document describes the VERIFY Assert Self-Contained Biological Indicator (SCBI) for monitoring steam sterilization processes. The acceptance criteria and testing are detailed for this device.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a medical device (Biological Indicator) and lacks specific information regarding studies involving AI, human readers, or image analysis. Therefore, the following sections will indicate that the information is not applicable based on the content.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes performance testing for biological indicators used in sterilization. It does not refer to "test sets" in the context of AI/machine learning or human reader studies. The data provenance is laboratory testing related to the performance of biological indicators under specific conditions rather than patient data. Specific sample sizes for each test are not explicitly detailed in the summary, but the resistance and population values are quantitative measurements of the device itself rather than data collected from a large number of 'samples' in the sense of a clinical trial. The testing is likely prospective and conducted in a controlled laboratory environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a biological indicator, and its performance is determined through standardized laboratory tests (e.g., spore count, D-value determination, growth/no growth observation) rather than interpretation by human experts.

4. Adjudication Method for the Test Set:

Not applicable. The determination of device performance (e.g., whether spores are killed, whether a fluorescent signal is produced) is based on objective laboratory measurements and biological principles, not expert adjudication.

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 document pertains to a biological indicator for sterilization monitoring, not an AI-powered diagnostic or interpretive device involving human readers.

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

Not applicable. The device itself is a biological indicator. Its "performance" involves a chemical/biological reaction monitored by a specific reader, but this is not an "algorithm" in the context of standalone AI performance. The reader provides a fluorescent result.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is established by:

• Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Fluorescent Signal: The detection of a fluorescent moiety produced by the organism's enzyme reacting with a substrate, indicating viability.
• Standardized Test Methods: Adherence to established standards like ISO 11138 and FDA guidance for biological indicators.
• Quantitative Measurements: D-values (decimal reduction time), survival time, kill time, and spore population counts based on microbiological assays.

8. The Sample Size for the Training Set:

Not applicable. This document does not describe an AI/machine learning model that requires a training set. The device is a physical biological indicator.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set for an AI model is described.

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Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.

The document provided describes the "VERIFY® Incubator for Assert™ Self Contained Biological Indicators" and its nonclinical testing to demonstrate substantial equivalence to a predicate device. This device is an incubator/reader used to incubate and automatically read self-contained biological indicators for sterilization processes.

Here's a breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

Study Proving the Device Meets Acceptance Criteria:

The document describes nonclinical performance testing.

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

• Sample Size: The document does not explicitly state the specific number of biological indicators (sample size) used for the qualification testing. It refers to "testing with SCBI exposed to full cycle exposure" and "testing with SCBI exposed in abbreviated cycle exposure," implying multiple indicators were tested.
• Data Provenance: The document doesn't specify the country of origin for the data. Given it's a submission to the FDA (United States), it is highly likely the testing was conducted in the USA or by a facility adhering to US regulations. The testing is described as "performance testing," which typically refers to prospectively collected data for validation purposes.

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

This device is an incubator/reader for biological indicators. The "ground truth" for this type of device is the actual growth or non-growth of microorganisms in the biological indicator, determined through traditional microbiological culturing methods (e.g., 7-day growth results for biological indicators). There is no mention of human experts (like radiologists) being involved in establishing the ground truth for this specific device, as its function is to automate the reading of a biological indicator. The "7-day growth results" serve as the objective ground truth.

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

Not applicable. The ground truth is based on the biological end-point (microbial growth/no growth), not subjective human interpretation requiring adjudication.

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 an automated incubator/reader for biological indicators, not an AI-assisted diagnostic imaging device that involves human reader interpretation. No human readers are involved in the "reading" process of this device.

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 (the incubator/reader) provides the fluorescent read, which is then compared against the established biological "truth" (7-day growth results). Its primary function is automated reading without human interpretation of its output beyond acknowledging the alarm or visual indicator.

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

The ground truth used is the microbiological growth status of the biological indicators, specifically the "7-day growth results." This is an objective measurement of whether the microorganisms in the biological indicator proliferated or not, which is the definitive indicator of sterilization effectiveness.

8. The sample size for the training set:

Not applicable. This document describes a traditional medical device (an incubator/reader) validated through performance testing, not a machine learning or AI-based device that typically requires a separate training set. The device's "knowledge" is built into its design (temperature control, fluorescence detection) rather than learned from a data set.

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

Not applicable, as there is no training set mentioned for this type of device.

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