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Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.

Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

The provided text does not contain information about acceptance criteria for a medical device's performance (such as sensitivity, specificity, or accuracy) or details about a study designed to prove the device meets these criteria. The document is an FDA 510(k) clearance letter for sterilization process indicators, not a performance study report for a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. How ground truth for the training set was established.

The document focuses on the regulatory clearance for biological and chemical indicators used to monitor sterilization processes, confirming their substantial equivalence to predicate devices, and outlining applicable regulations. It does not describe a clinical performance study as one would typically find for a diagnostic or AI device.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Flexible, Fast, Fast Non Lumen and Specialty Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· STERRAD® 100S Sterilizer (Default Cycle)

· STERRAD® 200 Sterilizer (Default Cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizer to include sterilizers with ALLClear® Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizer to include sterilizers with ALLClear® Technology.

The Celerity 20 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· STERRAD® 100S Sterilizer (Default Cycle)

• Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear® Technology
  · Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear® Technology

When used in conjunction with the Celerity HP Incubator or the Celerity Incubator, the Celerity HP BI provides a fluorescent result within 20 minutes.

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indication for use. It produces an optical change in signal that is detected by the STERIS proprietary reader, Celerity 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. 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 VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilities to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 SCBI into the V-PRO® Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

This document is a 510(k) premarket notification for two biological indicators: the Celerity 20 HP Biological Indicator and the VERIFY V24 Self-Contained Biological Indicator, both manufactured by STERIS Corporation. The purpose of the submission is to obtain clearance for these devices to routinely monitor additional sterilizer cycles, specifically the "Specialty Cycle" of the V-PRO® maX 2 Low Temperature Sterilization System, as well as several other specified STERRAD® cycles.

It's important to note that this document is for a sterilization process indicator, not a medical device in the typical sense (e.g., a diagnostic AI tool). Therefore, many of the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (like MRMC studies, expert consensus for imaging, etc.) do not apply here. This is a technical performance study for a biological measurement device, focusing on its ability to accurately reflect sterilization efficacy.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them for each of the two devices mentioned:

For the Celerity 20 HP Biological Indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text. The term "Celerity BIs" and "SCBIs" are used, implying multiple biological indicators were tested, but the exact number is not given.
• Data Provenance: The studies were non-clinical tests conducted by STERIS Corporation. The location (Mentor, OH) of the manufacturing and sponsor facility would suggest the studies were conducted in the USA. The data appears to be prospective as it's specifically for a new cycle qualification.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable in the context of this device. Ground truth for a biological indicator is typically established by the physical inactivation of bacterial spores under controlled, validated sterilization conditions, and the subsequent growth/no-growth determination. This is a direct measurement of sterility, not an interpretation of an image or signal that would require human expert consensus in the medical imaging sense.

4. Adjudication Method for the Test Set:

• Not applicable as this is a direct biological and physical process validation, not a diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images) with and without AI assistance. This device is a sterility indicator; its performance is measured by its biological response to sterilization, not by how humans interpret its output in a diagnostic scenario.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Yes, in principle. The performance of the biological indicator itself is "standalone." Its function is to respond directly to the sterilization process. The "reading" of the Celerity 20 HP BI is performed by the Celerity HP Incubator which detects a fluorescent signal within 20 minutes to confirm viability. While an instrument is involved, it's not an "algorithm" in the AI sense, but rather a direct measurement device. The studies described are assessing the BI's intrinsic performance against the sterilization cycle.

7. The Type of Ground Truth Used:

• Biological Inactivation/Sterility: The ground truth is the actual biological state of the spores on the biological indicator (e.g., killed or survived) after exposure to varying sterilization conditions. This is determined by observing the growth (or lack thereof) of the Geobacillus stearothermophilus spores under specific culture conditions, which then produces a fluorescent moiety if growth occurs. The "successfully qualified" aspect of the sterilizer cycle itself is the ultimate ground truth for the process the BI is monitoring.

8. The Sample Size for the Training Set:

• Not applicable. Biological indicators are not "trained" in the machine learning sense. Their function relies on the pre-defined biological characteristics of the Geobacillus stearothermophilus spores and the biochemical reaction designed into the device.

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

• Not applicable. (See #8)

For the VERIFY V24 Self-Contained Biological Indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. Similar to the Celerity BI, "SCBIs" (Self-Contained Biological Indicators) are mentioned, implying multiple units were tested, but the exact count is not provided.
• Data Provenance: The studies were non-clinical tests conducted by STERIS Corporation (likely in the USA). The data appears to be prospective for the new cycle qualification.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth for a biological indicator is typically established by the direct biological response of the bacterial spores to sterilization. While there's a visual detection of growth (color change/turbidity), this is a direct observation of a biological event, not a subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set:

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC study was not done.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Yes, in principle. The performance of the biological indicator itself is "standalone." Its function is to respond directly to the sterilization process. The "reading" of the VERIFY V24 SCBI involves visual detection of growth (media color change/turbidity) after incubation. While this involves human observation, it's observing a biological fact (growth/no growth), not interpreting an image or signal in a diagnostic sense. The studies described are assessing the BI's intrinsic performance against the sterilization cycle.

7. The Type of Ground Truth Used:

• Biological Inactivation/Sterility: The ground truth is the actual biological state of the spores on the biological indicator (e.g., killed or survived) after exposure to varying sterilization conditions. This is determined by observing the growth (color change from orange to yellow and/or turbidity) or no-growth (media remains orange and non-turbid) of the Geobacillus stearothermophilus spores after incubation. The "successfully qualified" aspect of the sterilizer cycle itself is the ultimate ground truth for the process the BI is monitoring.

8. The Sample Size for the Training Set:

• Not applicable. Biological indicators are not "trained."

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

• Not applicable.

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The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum).

The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 - mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple.

The provided document is a 510(k) premarket notification for a medical device: the True Indicating Self-Contained Biological Indicator. This device is a biological indicator used to monitor the efficacy of steam sterilization processes. The document outlines the device's characteristics, intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

It's crucial to understand that this document describes the validation of a physical, in-vitro biological indicator, not an AI-powered diagnostic device or software. Therefore, many of the requested fields related to AI/MRMC studies, number of experts for ground truth establishment, data provenance for test/training sets, and adjudication methods are not applicable to this type of device and its validation.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, with explicit notes where information is not applicable:

Acceptance Criteria and Device Performance for True Indicating Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact numerical sample sizes (e.g., number of BIs tested) for each test. Instead, it refers to conducting tests "using multiple lots of True Indicating SCBI for Steam over the range of the shelf life." This implies a sufficient number of units were tested to meet the requirements of the referenced ISO standards (ISO 11138-1:2017, ISO 11138-3:2017) and FDA guidance for BI submissions.
• Data Provenance: The data is generated from non-clinical laboratory testing of the physical medical device. The document does not specify country of origin for the testing itself, but the submission is to the U.S. FDA, and tested against international (ISO) and U.S. (FDA) standards. This is not retrospective or prospective in the sense of clinical study data; it's product performance testing.

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

• Not Applicable. This is a non-clinical device that relies on a physical, chemical, and biological reaction (spore inactivation and subsequent growth/no-growth). The ground truth is objective and established by the physical and biological properties of the system (e.g., spore count, thermal resistance characteristics, visual color change indicating growth) under controlled experimental conditions according to recognized international and national standards. There are no human "experts" establishing a "ground truth" through interpretation in the way there would be for an AI diagnostic device.

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

• Not Applicable. As this involves objective, quantifiable laboratory measurements of a physical device's performance, judicial adjudication methods are not relevant. The results are determined by the specified test protocols and acceptance criteria.

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 is not an AI-powered device or a diagnostic device that involves human readers interpreting images or data. Therefore, MRMC studies are irrelevant.

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

• Not Applicable. This is a physical biological indicator, not an algorithm.

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

• The ground truth is established through objective laboratory measurements and biological principles as defined by recognized standards (ISO 11138 series) and FDA guidance documents for biological indicators. For example:
  • Viable Spore Population: Determined quantitatively by plating and counting colony-forming units.
  • D-value and Z-value: Calculated from survival curves generated under controlled sterilization conditions.
  • Survival/Kill Time: Demonstrated by whether spores survive or are inactivated after specific exposure times, verified by incubation and visible growth/no growth.
  • Reduced Incubation Time: Verified by statistical alignment (greater than 97%) of 10-hour results with conventional 7-day incubation results, where growth (yellow media) indicates sterilization failure and no growth (purple media) indicates success.
  • Simulated Use: Demonstrated by objective growth/no-growth results after exposure to specific sterilization cycles (abbreviated cycle = growth, half cycle = no growth, full cycle = no growth), ensuring the indicator performs as expected under varied challenge levels.

8. The sample size for the training set

• Not Applicable for this type of device. Training sets are relevant for machine learning algorithms. This device is a physical biological indicator validated through non-clinical performance testing.

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

• Not Applicable for this type of device. See point 8.

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The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring 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 STERIS Corporation VERIFY Assert Self-Contained Biological Indicator (SCBI) is a Class II device (21 CFR 880.2800, Product code FRC) intended for monitoring steam sterilization processes.

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• *: Based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
• **: Minimum acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
• ‡: Based on specifications of the reference device, VERIFY Assert Self-Contained BI

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

The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., number of SCBIs tested for RIT, viable spore population, etc.). It only provides the acceptance criteria and the conclusion (PASS) or the measured performance range.

The data provenance is from non-clinical testing conducted by STERIS Corporation for their VERIFY Assert Self-Contained Biological Indicator. This would inherently be prospective data collection as it's part of a device validation study. The country of origin of the data is not specified, but the applicant (STERIS Corporation) is based in Mentor, Ohio, USA.

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

This device is a biological indicator for sterilization processes. The "ground truth" for its performance is established through laboratory testing against well-defined, standardized sterilization parameters and biological growth assessment, rather than expert human interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of results (like in a medical imaging AI study) does not directly apply here. The "experts" involved would be the microbiologists and engineers who designed, executed, and analyzed the validation studies, ensuring adherence to standards like those outlined in FDA guidance documents and AAMI. Their qualifications would typically involve expertise in microbiology, sterilization science, and quality assurance for medical devices.

4. Adjudication method for the test set

Not applicable. As explained above, the "ground truth" is determined by objective biological and physical measurements and adherence to established scientific and regulatory standards for sterilization indicators, not by a panel of human adjudicators.

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, not an AI-powered diagnostic tool requiring human interpretation. Its function is to provide an objective fluorescent signal detected by a reader to indicate sterilization success or failure.

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

Yes, in a way. The performance testing described is essentially a "standalone" assessment of the device's ability to accurately indicate sterilization conditions. The VERIFY Assert SCBI, when used with its proprietary reader, provides a fluorescent result within 40 minutes. This means the device itself, in conjunction with its automated reader, generates the result without human interpretation of a complex output. The human role is to observe the positive or negative signal from the reader. The tests confirm the device's intrinsic biological resistance and signal generation properties under various sterilization conditions and incubation parameters.

7. The type of ground truth used

The ground truth used for this device is based on:

• Microbiological Growth Assessment: Direct observation of bacterial growth (or lack thereof) after exposure to sterilization cycles, often confirmed by conventional incubation methods (e.g., 7 days of incubation) to establish true viability.
• Physical and Biological Standards: Adherence to established performance metrics ($D_{value}$, spore population) defined by regulatory guidance (FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions) and industry consensus standards (e.g., AAMI for sterilization processes).
• Controlled Sterilization Cycles: Exposure to precisely controlled steam sterilization cycles (e.g., abbreviated cycles to show growth, full cycles to show kill) to challenge the BI.

8. The sample size for the training set

Not applicable. This device is a biological indicator and does not employ machine learning or AI algorithms that would require a "training set." Its biological and chemical principles of operation are deterministic, based on the survival and metabolic activity of a target microorganism.

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

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

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The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.

The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.

Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.

The Sterilucent SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.

The document describes the acceptance criteria and study results for the Sterilucent Self-Contained Biological Indicator (SCBI) and Process Challenge Device (PCD).

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 specify the exact sample sizes used for each individual test. The provenance of the data is not explicitly stated in terms of country of origin, but the submission is for the U.S. Food and Drug Administration (FDA), implying the testing was conducted to meet U.S. regulatory standards. The testing appears to be prospective as it was conducted to demonstrate the functionality of the device.

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. The device is a biological indicator and process challenge device for sterilization. Its performance is evaluated through biological and physical tests based on established standards, not through expert interpretation of data like in diagnostic imaging.

4. Adjudication method for the test set

This information is not applicable for this type of device and testing. The evaluation relies on quantitative measurements and adherence to predefined performance metrics rather than expert consensus on subjective outcomes.

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 sterilization indicator, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

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

This information is not applicable. The device itself is non-algorithmic and does not involve AI or human-in-the-loop performance in the conventional sense of software-as-a-medical-device. Its performance is inherent to its design and material properties.

7. The type of ground truth used

The ground truth for the SCBI and PCD testing is established by recognized international standards and methodologies for sterilization indicators. This includes:

• Biological inactivation: The absence or presence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Physical/chemical parameters: Measurements of D-value, survival/kill windows, spore population counts, pH changes, and color changes in chemical indicators.
• Compliance with standards: Adherence to ANSI/AAMI/ISO 11138-1, ANSI/AAMI/ISO 11140-1, and FDA Guidance documents.

8. The sample size for the training set

This information is not applicable. The Sterilucent SCBI and PCD are not AI/ML-based devices; therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable as the device does not utilize a training set in the AI/ML sense.

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The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The Celerity HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/yellow or lighter, when the device has been exposed to the:

• . Lumen, Non-Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• . Standard. Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity "10 HP Chemical indicator is provided in three formats:

• Version 1: Celerity™ Chemical Indicator (CI) .
• . Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
• Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)

The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.

The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:

• Construction C Polypropylene ●
• Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper
• Construction D - polypropylene with an adhesive and a glassine backing paper.

The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• When exposed to VHP Resistometer cycles at the Pass condition (Test Point 1): Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. | Pass |
  | Simulated Use Testing | Internal Method Used | - When exposed to V-PRO maX Non Lumen 1/84 cycles with ≥50 lb load (Fail condition): 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result.
• When exposed to V-PRO and STERRAD cycles with the worst case loads: Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. | Pass |
  | Fluorescent Light Stability Testing | Internal Method & ANSI/AAMI/ISO 11140-1:2014 | - Indicator start color to remain unchanged after exposure to fluorescent lighting for ≥ 30 days before processing.
• When exposed to VHP Resistometer cycles at the Fail parameters following exposure to fluorescent lighting for ≥ 30 days: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).
• When exposed to VHP Resistometer cycles at the PASS parameters following exposure to fluorescent lighting for ≥ 30 days: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). | Pass |
  | Temperature Extremes Exposure (Freeze/Thaw) Testing | Internal Method & ANSI/AAMI/ISO 11140-1:2014 | - Indicator start color to remain unchanged after exposure to extreme temperatures before processing.
• When exposed to VHP Resistometer cycles at the Fail parameters following exposure to extreme temperatures: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).
• When exposed to VHP Resistometer cycles at the PASS parameters following exposure to extreme temperatures: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). | Pass |
  | Transference Testing | ANSI/AAMI/ISO 11140-1:2014 | - Indicators placed between a piece of the same substrate and held together with tape, then processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for off-set, bleed and migration. | Pass |
  | | | - Samples with reference and text ink processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for smearing, discoloration and fading. | Pass |
  | Adhesion Stability (Vials) Testing | Internal Method Used | - When exposed to two consecutive V-PRO maX 2 Lumen cycles:
  • 0% samples show bleeding of the adhesive
  • 100% must be firmly affixed
  • 0% must show signs of peeling
  • Minimum 90% must show a PASS result | Pass |
  | Shelf Life Testing | ANSI/AAMI/ISO 11140-1:2014 | - After the process indicator has been aged: Minimum of 90% of indicators must PASS Type 1 PASS conditions.
• After the process indicator has been aged: 100% of indicators must FAIL. | Pass |
  | Post-Processing Stability Testing | Internal Method Used | - Indicator processed ink color remains unchanged for a minimum of 6 months following exposure to a PASS or FAIL cycle. | Pass |

2. Sample Size and Data Provenance for Test Set:

The document does not explicitly state the specific sample sizes (number of indicators) used for each individual test in the performance studies. However, for "Type 1 Performance Testing", "Simulated Use Testing", "Fluorescent Light Stability Testing", "Temperature Extremes Exposure Testing", "Shelf Life Testing", and "Adhesion Stability (Vials) Testing", the acceptance criteria mention percentages (e.g., "100% Celerity™ HP Chemical Indicator stripes", "Minimum 90% Celerity™ HP Chemical Indicator stripes"). This implies that multiple indicators were tested for each condition.

The data provenance is not explicitly stated in terms of country of origin. The manufacturing facility is in the United Kingdom, but the testing may have occurred elsewhere. The studies are described in the context of a 510(k) submission, which typically involves prospective testing designed to meet regulatory requirements.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

This information is not provided. The performance testing for these chemical indicators relies on objective color changes and adherence to established standards (ANSI/AAMI/ISO 11140-1:2014), rather than expert interpretation of the results. The 'ground truth' is the objective physical change of the chemical indicator based on exposure to sterilization conditions.

4. Adjudication Method for the Test Set:

Not applicable. The performance testing for chemical indicators is based on objective observable color changes and compliance with quantitative standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or other data, and the comparison is how AI assistance affects their diagnostic accuracy. Chemical indicators, like the Celerity™ HP, are designed for direct visual interpretation of a color change, not complex interpretation by multiple human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, the studies described are standalone performance studies of the chemical indicator itself. The device is a "Type 1 vaporized hydrogen peroxide sterilization process indicator" that provides a direct visual cue (color change) to indicate exposure to sterilization conditions. Its performance is evaluated based on its intrinsic ability to change color accurately under specific conditions, without human interpretation beyond basic color recognition.

7. Type of Ground Truth Used:

The ground truth used is primarily based on physical exposure to defined sterilization conditions (VHP Resistometer cycles at specific "Fail parameters" and "Pass condition", and various V-PRO and STERRAD cycles with worst-case loads). The observable color change (or lack thereof) in the chemical indicator is then compared against these known exposure conditions to determine if the indicator provides an accurate visual signal according to the standard.

8. Sample Size for Training Set:

Not applicable. Chemical indicators are passive devices that rely on a chemical reaction for their function, not on machine learning algorithms that require a "training set" of data.

9. How Ground Truth for Training Set was Established:

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

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers

· STERRAD® 100S Sterilizer (default cycle)

• STERRAD® 200 Sterilizer (default cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with All Clear Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizers with All Clear technology

The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 SCBI into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included. The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

Here's a breakdown of the acceptance criteria and study information for the VERIFY V24 Self-Contained Biological Indicator and VERIFY V24 Biological Indicator Challenge Pack, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document presents separate acceptance criteria and testing for the "Self-Contained Biological Indicator (SCBI)" and the "Challenge Pack."

For the VERIFY V24 Self-Contained Biological Indicator (SCBI):

For the VERIFY V24 Biological Indicator Challenge Pack:

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

The document does not explicitly state the numerical sample size used for the test set in any of the studies. It refers to "All test SCBIs" and "All processed SCBIs" without providing a count.

The data provenance is not specified beyond being "nonclinical tests" and "performance testing to demonstrate substantial equivalence to the predicate." There is no mention of country of origin or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The document describes tests related to the biological and chemical indicators themselves and their performance in sterilization cycles, not a diagnostic or interpretive task that would typically involve human expert adjudication for ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the tests described are objective measures of biological indicator performance (e.g., growth/no growth, color change, spore population) rather than subjective assessments 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

This is not applicable. The device described (Biological Indicator and Challenge Pack) is a sterilization process indicator, not an AI or imaging device that would typically be involved in human-in-the-loop diagnostic tasks or benefit from a reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical biological indicator, not an algorithm. Its performance is evaluated through laboratory and simulated use testing.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be based on:

• Biological viability: Growth or lack thereof of Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by a color change in the growth medium.
• Established physical and chemical properties: D-value, survival time, kill time, and viable spore population are laboratory-measured physical characteristics against established standards.
• Chemical indicator color change: A visible, objective change in color on the indicator.
• Comparative resistance: The challenge pack's resistance compared to a "worst case biological model."

Essentially, the "ground truth" is defined by the expected biological or chemical response to a sterilization process.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for a biological indicator. The tests described are performance and validation tests, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of device.

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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® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:

• · Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
• · Standard Cycle of the STERRAD® 100S Sterilizer
• · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer

The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media.

The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included.

The user places the VERIFY V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

This document describes the acceptance criteria and study proving the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Challenge Pack meet these criteria.

VERIFY® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

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The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert VH2O2 Self-Contained Biological Indicator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. 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 text describes the acceptance criteria and the summary of non-clinical tests for the "VERIFY Assert VH2O2 Self-Contained Biological Indicator". However, it's important to note that this document is for a biological indicator used in sterilization processes, not an AI/ML powered medical device for diagnostic purposes. As such, some of the requested information (like MRMC study, human reader improvement with AI, ground truth for training AI, etc.) is not applicable to this type of device.

Here's the information extracted and adapted where possible:

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

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

The document summarizes "non-clinical tests" but does not explicitly state the specific sample sizes for each test in the acceptance criteria table. It refers to "testing in accordance with FDA guidance for BI 510(k)" and "ISO 11138–1 media testing," which would imply standardized testing protocols that define sample sizes. Without further details of these specific tests, the exact sample sizes cannot be determined from the provided text.

The data provenance is not specified in terms of country of origin or explicit retrospective/prospective design. However, the tests are laboratory-based and conducted by the manufacturer, STERIS Corporation, in the US.

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 to a biological indicator. The "ground truth" for a biological indicator is determined by the survival or inactivation of Geobacillus stearothermophilus spores under specific sterilization conditions, which is a microbiological and chemical measurement, not an expert human interpretation.

4. Adjudication method for the test set:

Not applicable, as the evaluation is based on objective microbiological and chemical results, 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 device is a biological indicator for sterilization, not an AI-powered diagnostic tool requiring human reader studies.

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

The device itself is a "self-contained biological indicator" that produces a fluorescent result, which is then detected by an "automated incubator/reader." In this sense, the "algorithm" equivalent is the biological and chemical reaction within the indicator, and its detection by the automated reader. The performance described in the acceptance criteria is essentially its standalone performance in various conditions. There's no "human-in-the-loop" for the primary result generation, only for interpreting the automated reader's output.

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

The ground truth used for testing this biological indicator is based on:

• Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Chemical/Biological reactions: The enzyme reaction with a fluorogenic substrate to produce a fluorescent moiety, detected by the incubator.
• Standardized testing methods: Adherence to FDA guidance for BI 510(k) and ISO 11138–1 standards, which define the expected biological and chemical responses under controlled conditions (e.g., D-value, survival time, kill time).

8. The sample size for the training set:

Not applicable in the context of an AI/ML training set. This is a physical device, and its "performance" is inherent to its design and manufacture, validated through a series of non-clinical tests.

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

Not applicable in the context of an AI/ML training set. The "ground truth" for the device's development (if one were to call it that) would come from established principles of microbiology and sterilization science, as well as the performance characteristics of its constituent materials and biological components.

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