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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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The 3MTM Attest ™ 293 Auto-reader is designed to incubate and automatically read the SM - Allest - - TEO Parfinal negative fluorescence reading at 1 hour for 1291 or 3 hours for 1292.

The 3M™ Attest ™ 293 Auto-reader is also designed to allow for further The SM - Attest 1291 and/or the Attest 1292 Rapid Readout Biological Indicators for a final negative, visual pH color change of the growth media at 24 hours for 1291 and 48 hours for 1292.

The 3M™ Attest ™ 293G Auto-reader is designed to incubate and automatically The SM - Attest - 2300 Auto Todor 16 Cougical Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.

The own Attoot 2007 late reas (BI), which are incubated at 60 °C. The initial Bls in this series to receive market clearance were the 1291 (K900771) and 1292 (K926364).

The purpose of these Bls is to assess whether a potential failure of a steam sterilization cycle has occurred. Please note that both of these initial premarket sterfilizations (K900771) and (K926364) listed the 3M Attest 190 Auto-reader as houncations (13007 17 and (102000 1) 1102000 1) 1100 Auto-reader was cleared (K004009) for use with these Bls and serves as the predicate device for the new Model 293 Auto-reader.

The Attest 293 is comprised of three (3) Attest 290 units within a single case.

The 3M Attest 293G Auto-reader is an accessory to the 3M Attest 1294 Rapid Readout EO Biological Indicator (RRBI) which is to be incubated at 37 °C.

The purpose of these Bls is to assess whether a potential failure of an ethylene oxide sterilization cycle has occurred. The model 290G was cleared (K031012) with the Attest 1294 Bl and serves as the predicate for the 293G.

The Attest 293G is comprised of three (3) Attest 290G units within a single case.

The provided document is a 510(k) Premarket Notification summary for the 3M™ Attest™ 293/293G Auto-reader. It states that the new device is "substantially equivalent" to predicate devices (Attest 290 and 290G Auto-readers) because they use the same technology, software, and have the same indications for use and intended use. The new device is essentially a "three units within one case" configuration of the predicate.

Therefore, the submission does not contain information about a new study with acceptance criteria and device performance evaluation as would be typical for a device with a new technological approach or significantly different intended use. Instead, it relies on the established performance of its predicate devices due to its substantial equivalence in design and function.

As such, many of the requested details about a study for acceptance criteria cannot be extracted from this document, as a new, standalone performance study demonstrating new acceptance criteria was not conducted or reported in this 510(k) summary. The "acceptance criteria" here is implicitly demonstrating substantial equivalence to the predicate.

Here's an attempt to answer based on the provided text, acknowledging the limitations:

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

The document does not explicitly state acceptance criteria or a performance table for a new study. The acceptance criteria for the 510(k) itself is demonstrating "substantial equivalence" to the predicate devices. The "reported device performance" is implicitly considered to be the same as the predicate devices:

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

Not applicable. No new test set data is provided as the submission relies on substantial equivalence to predicate devices.

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

Not applicable. No new test set requiring expert ground truth establishment is reported.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication is reported.

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 auto-reader for biological indicators, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

The device itself is a standalone auto-reader. However, no new standalone performance study (beyond demonstrating it functions as three predicate units) is mentioned. Its performance is considered equivalent to the predicate devices which have established standalone performance.

7. The type of ground truth used

For the predicate devices, the ground truth for evaluating biological indicators (BI) would typically involve microbiological confirmation of sterility (or failure to achieve sterility) in a controlled laboratory setting, which could be considered a form of "pathology" or definitive outcome data regarding the sterilization process. However, this document does not detail how the ground truth for the predicates was established, only that the new device is equivalent.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm or a new training set. The device's operation is based on established auto-reading technology for biological indicators.

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

Not applicable. No training set is described in this document.

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