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Celerity 5 HP Biological Indicator:
The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack:
The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

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 monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non-Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®

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

Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

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 monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 5 HP BI
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, STERIS Celerity Incubator, within 5 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.

Celerity 5 HP Challenge Pack
The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

The intended change to the devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

Celerity 20 HP BI
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, STERIS Celerity 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.

Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

The intended change to these devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

The provided text describes premarket notification for biological indicators and doesn't involve an AI/ML powered medical device. Therefore, many of the requested criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study" or "number of experts used to establish ground truth", which are specific to AI/ML powered devices, are not applicable here.

However, I can extract information related to the acceptance criteria and the study proving the device meets those criteria, as much as applicable for a non-AI medical device.

Device: Celerity 5 HP Biological Indicator (LCB052) & Challenge Pack (LCB059), and Celerity 20 HP Biological Indicator (LCB044) & Challenge Pack (LCB045)

Type of Device: Sterilization Process Indicator (Biological Indicator - BI). These devices contain a specific type of spore (Geobacillus stearothermophilus) and media to confirm the effectiveness of a sterilization process. A positive result (fluorescent signal) indicates sterilization failure, while a negative result indicates successful sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and results are provided for two distinct product lines: Celerity 5 HP and Celerity 20 HP. Note that the "Result" for all tests is simply "PASS", indicating that the criteria were met.

For Celerity 5 HP Biological Indicator and Challenge Pack:

For Celerity 20 HP Biological Indicator and Challenge Pack:

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

The document does not explicitly state the numerical sample size (e.g., number of BIs or challenge packs) used for each specific test (Reduced Incubation Time, Simulated Use, Cap Media, Stability testing). It refers to "All BI lots" for Reduced Incubation Time and "All processed BIs" for Simulated Use, and implicitly "BIs" for Stability Testing. This suggests a statistically relevant number of units from manufactured lots were tested.

• Data Provenance: The document does not specify the country of origin of the data. Given the "U.S. Food & Drug Administration" letterhead and the manufacturer's address in Ohio, USA, it is highly likely that the testing was conducted in the US.
• Retrospective or Prospective: The testing appears to be prospective as it's a pre-market submission to demonstrate the device meets performance criteria for clearance. Stability testing also inherently involves prospective observation over time.

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

This concept is not applicable to this type of device. The "ground truth" for a biological indicator is determined by the biological and chemical reactions themselves (i.e., presence or absence of viable spores, or a color change in the chemical indicator), not by human expert interpretation of images or data. The determination of "sterile" or "non-sterile" from a biological indicator is a direct, objective measurement.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the results of biological indicators are typically objective and determined by the physical/chemical properties and reactions, not by 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 is not an AI/ML device nor one that involves human "readers" interpreting medical images or data.

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

Not applicable. This is a physical, biological and chemical indicator device, not a software algorithm. The "Celerity Incubator" is an accessory that reads the fluorescent signal, it is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for these devices is based on biological viability (presence or absence of viable Geobacillus stearothermophilus spores) for the biological indicator and chemical reaction (color change) for the chemical indicator, validated against recognized sterilization parameters (e.g., D-value, Survival Time, Kill Time). This is a direct measure of the effectiveness of the sterilization process.

8. The Sample Size for the Training Set

Not applicable. These are not AI/ML devices that require training sets. The "training" of these devices (i.e., their manufacturing and design) is based on established microbiological and sterilization science.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance of these biological indicators relies on their inherent design and manufacturing quality, ensuring the spores exhibit the specified resistance characteristics and the media accurately detects their viability. This is established through rigorous quality control and adherence to relevant standards for biological indicators.

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Celerity 5 HP Biological Indicator (LCB052), Celerity 5 HP Challenge Pack (LCB059), Celerity 20 HP Biological Indicator (LCB044), Celerity 20 HP Challenge Pack (LCB045)

Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is intended for 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, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterlizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chad is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

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

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chaded. The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 5 HP BI

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, STERIS Celerity Incubator, within 5 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.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

Celerity 20 HP BI

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, STERIS Celerity 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.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

The provided document is a 510(k) summary for STERIS Corporation's Celerity 5 HP and Celerity 20 HP Biological Indicators and Challenge Packs. It details non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human readers or AI algorithms for diagnostic purposes.

Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the-loop performance) was done," are not applicable to the information contained in this document. This document describes the performance of a physical medical device (Biological Indicator) intended to monitor sterilization cycles, not a software-based diagnostic tool or AI.

However, I can extract and present the relevant acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

The document presents non-clinical performance testing for two sets of devices: Celerity 5 HP Biological Indicator/Challenge Pack and Celerity 20 HP Biological Indicator/Challenge Pack. The tables below combine the acceptance criteria and results for both, as they largely follow similar testing methodologies.

Celerity 5 HP Biological Indicator and Challenge Pack (Table 3)

Celerity 20 HP Biological Indicator and Challenge Pack (Table 6)

Study Details (Based on available information)

As noted, many elements of the request are not applicable as this document pertains to a physical biological indicator, not an AI or imaging diagnostic device.

1. Sample size used for the test set and the data provenance: The document uses terms like "All BI lots" and refers to testing of the biological indicators themselves rather than a "test set" of patient data. Specific sample sizes for each non-clinical test are not explicitly stated in this summary. The data provenance is from non-clinical laboratory testing performed by STERIS Corporation. There is no indication of country of origin of data or whether it was retrospective/prospective in a clinical sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biological indicators in sterilization involves laboratory-based microbiology (e.g., presence or absence of spore growth in controlled environments), not expert human interpretation like radiologists for images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a non-clinical device performance study, not a human reader study requiring adjudication.

4. 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-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical biological indicator. The performance is assessed in a laboratory setting. The "Celerity Incubator" detects the fluorescent signal, but this is a device accessory, not an AI algorithm.

6. The type of ground truth used: The ground truth for the biological indicators is based on the viability of Geobacillus stearothermophilus spores, determined by their ability to grow and produce a fluorescent signal (or lack thereof) under specific, controlled laboratory conditions after exposure to sterilization processes. This is a direct microbiological assessment.

7. The sample size for the training set: Not applicable. This is a physical device that undergoes performance testing, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established: Not applicable. As above, there is no "training set" in the context of this 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 Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 and s2 Low Temperature Sterilization Systems.

• · STERRAD® 100S Sterilizer (Default Cycle)
• · Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
• · Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

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

The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

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 monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

Biological Indicator: 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, 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.

Challenge Pack: The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI 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 BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator* for a final determination of viability within 20 minutes of incubation.

Here's a breakdown of the acceptance criteria and study information for the Celerity 20 HP Biological Indicator and Celerity 20 HP Challenge Pack, based on the provided document.

CELERITY 20 HP Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

   Test	Acceptance Criteria	Reported Device Performance
   BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle	All BIs processed in full cycles will be negative for growth	PASS
   Recoverable Population after exposure to STERRAD ALLClear	Recoverable Population of 50 – 300% of the label claim	PASS

2. Sample Size and Data Provenance: The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing demonstrated that the subject device met its acceptance criteria."

3. Number of Experts and Qualifications: Not applicable for this type of device (biological indicator testing for sterilization).

4. Adjudication Method: Not applicable for this type of device. The determination of "negative for growth" or "recoverable population" is based on objective microbiological assays.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an objective indicator, not subject to human reader interpretation in the context of diagnostic imaging.

6. Standalone (Algorithm Only) Performance: The document describes the Celerity 20 HP BI as a standalone device whose performance is assessed through its growth characteristics after exposure to sterilization cycles. The "fluorescent result within 20 minutes" when used with the Celerity HP Incubator is the objective output of the system.

7. Type of Ground Truth Used: The ground truth is based on the biological viability of Geobacillus stearothermophilus spores after exposure to sterilization, and the quantitative recovery of these spores. This is a direct measure of microbial survival/kill.

8. Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set in that sense. The device is a biological indicator with inherent characteristics that are tested.

9. How Ground Truth for Training Set was Established: Not applicable.

CELERITY 20 HP Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

   Test	Acceptance Criteria	Reported Device Performance
   Simulated Use	Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions	PASS
   Cycle-Specific Testing	The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions.	PASS

2. Sample Size and Data Provenance: Similar to the Biological Indicator, the document does not explicitly state the sample size used for the test set or the data provenance. It states "Performance testing demonstrated that the subject device met its acceptance criteria."

3. Number of Experts and Qualifications: Not applicable.

4. Adjudication Method: Not applicable. The results are based on the objective outcome of the biological indicator and chemical indicator within the pack after a sterilization cycle.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (Algorithm Only) Performance: The CELERITY 20 HP Challenge Pack's performance is intrinsically standalone, as it's a physical pack designed to present a challenge to the sterilization process. Its outcome is determined by the biological and chemical indicators it contains.

7. Type of Ground Truth Used: The ground truth is established by assessing the biological (spore kill/survival) and chemical (color change) indicators within the pack after exposure to standardized sterilization conditions, particularly under "worst-case sterilization conditions" and against a "biological model."

8. Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set was Established: Not applicable.

Overall Note: This document describes the 510(k) submission for a traditional biological indicator and challenge pack, not an AI/ML powered device. Therefore, many of the requested points related to AI/ML study methodologies (experts, adjudication, MRMC, training sets) are not applicable to this submission. The focus is on the physical and biological performance characteristics of the indicator and pack.

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The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological 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, 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 provided document is a 510(k) premarket notification for a medical device called the CELERITY 20 HP Biological Indicator. This device is a sterilization process indicator and, as such, there is no AI/Algorithm component to its function. Therefore, several of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, how training ground truth was established, effect size of human readers with/without AI) are not applicable to this type of device.

Here's the relevant information that can be extracted:

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)

• Sample Size for Test Set: The document does not specify the exact number of biological indicators (BIs) used in the "Simulated Use" test. However, it implicitly refers to a "worst-case cycle with a worst-case load," which suggests a controlled laboratory setting.
• Data Provenance: The study appears to be a laboratory-based performance study conducted by STERIS Corporation (Mentor, OH, USA), as indicated by the "Summary of Nonclinical Tests." It is prospective in nature as it involves testing the device's performance under specified conditions.

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)

Not applicable, as this is a physical biological indicator, not an AI/algorithm-driven device requiring expert interpretation of results for ground truth. The "ground truth" is the known sterility condition of the sterilization cycle.

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

Not applicable. The result of a biological indicator is typically a clear "growth" or "no growth" binary outcome, observed directly by laboratory personnel following established protocols.

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, as this device is a biological indicator, not an AI system.

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

Not applicable, as this device is a biological indicator, not an AI system. The device itself (the biological indicator and its incubator) provides a standalone result (fluorescent signal within 20 minutes) without human-in-the-loop interpretation beyond reading the incubator's output.

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

The ground truth for this device's performance is the known sterility or non-sterility of the sterilization cycle. This is established through controlled laboratory conditions where cycles are designed to either sterilize completely or to represent a "worst-case" scenario that should prevent complete inactivation of the BI. The "no growth of BI" result is then compared against this known condition.

8. The sample size for the training set

Not applicable, as this device does not use an AI/algorithm that requires a training set.

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

Not applicable, as this device does not use an AI/algorithm that requires a training set.

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The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological 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, 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.

Based on the provided text, here's a detailed description of the acceptance criteria and the study proving the device meets them:

Device: CELERITY 20 HP Biological Indicator (K172752)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the numerical sample size for each test. However, it indicates that for the "BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle" test, "All BIs processed in full cycles" were evaluated. This implies quantitative measurements were taken on a set of BIs.
• Data Provenance: The studies are described as "Performance testing" and "Nonclinical Tests" submitted by Steris Corporation. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective; however, given they are non-clinical hardware tests, they would inherently be prospective laboratory experiments.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device is a biological indicator (hardware) for sterilization processes and its performance is measured against objective criteria (e.g., spore viability, D-value, growth/no growth), not subjective expert interpretation of output data like medical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where multiple human readers assess cases and their interpretations need to be reconciled to establish a ground truth. For a biological indicator, the "ground truth" is determined by objective biological and chemical measurements (e.g., spore growth, fluorescent signal detection).

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

Not applicable. An MRMC study assesses the impact of an AI device on human reader performance, usually in diagnostics like radiology. The CELERITY 20 HP Biological Indicator is a standalone device that provides an objective result for sterilization efficacy, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. All tests mentioned in the table (Resistance, Survival Time, Kill Time, Reduced Incubation Time, Viable Spore Population, Carrier Growth Inhibition/Media Growth Promotion, Hold Time, and Simulated Use) represent standalone performance evaluations of the Biological Indicator itself, with its specified incubator/reader providing the result. The device's performance is determined by its inherent biological and chemical properties.

7. Type of Ground Truth Used

The ground truth used is based on:

• Biological Activity: The presence or absence of Geobacillus stearothermophilus spore growth, which indicates sterilization failure.
• Physical/Chemical Measurements: D-values, survival times, kill times, and spore population counts determined through standard microbiological and sterilization efficacy testing methods.
• Objective Readouts: The fluorescent signal detected by the CELERITY 20 HP Incubator within 20 minutes, indicating viability or non-viability.

8. Sample Size for the Training Set

Not applicable. This device is a biological indicator, not an AI device developed using machine learning that requires a training set. Its functionality is based on direct biological and chemical reactions.

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

Not applicable, as no training set was used for this type of device.

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The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems.
• STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer
When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

The subject device 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. CELERITY Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), 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 BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on 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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of BIs per sterilization cycle for half-cycle, growth inhibition, or simulated use tests). It mentions "All BIs" in the acceptance criteria, suggesting a comprehensive evaluation.

The data provenance is from non-clinical testing performed by STERIS Corporation, a manufacturer in the United States (Mentor, Ohio). The studies are prospective as they are conducted to demonstrate the performance of the device for regulatory clearance.

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

This type of information is not applicable to this device. Biological Indicators (BIs) rely on the growth or non-growth of a reference microorganism (Geobacillus stearothermophilus) under controlled conditions to determine sterilization effectiveness. The "ground truth" is established through microbiological principles (presence/absence of live spores and enzyme activity) rather than expert interpretation of complex data (like medical images).

4. Adjudication Method for the Test Set

This is not applicable as the results are based on objective biological and chemical reactions (fluorescence, growth/no growth), not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices where human readers interpret outputs, often with and without AI assistance. This device is a biological indicator for sterilization monitoring, and its performance is evaluated directly through biological and chemical tests.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance evaluation is standalone (algorithm only) in the sense that the device's mechanism (fluorescence detection by the Celerity HP Incubator) operates automatically without human intervention once the BI is placed in the incubator. The results (fluorescent within 20 minutes for growth, or lack thereof) are objective outputs of the system. Human involvement is limited to placing the BI in the incubator and observing the incubator's output indicator.

7. The Type of Ground Truth Used

The ground truth is based on microbiological principles and direct observation of microbial growth or enzyme activity. Specifically:

• For sterilization efficacy, the ground truth is the absence of viable Geobacillus stearothermophilus spores after processing.
• For growth promotion/inhibition, the ground truth is the presence of viable Geobacillus stearothermophilus spores and their ability to grow, or the enzyme reaction leading to fluorescence.
• Reduced Incubation Time (RIT) Testing compared the 20-minute fluorescent results to the conventional 7-day incubation time results (which would involve visual inspection for growth over a longer period).

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this biological indicator. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its performance is based on established biological and chemical reactions and engineering controls.

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

As there is no "training set" for this device, this question is not applicable.

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