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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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Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

The provided text describes the Celerity Incubator, a Class II medical device, and its performance testing to demonstrate substantial equivalence to a predicate device. This device is designed to incubate and automatically read STERIS Celerity Biological Indicators for sterilization processes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., how many biological indicators were tested for the Qualification Testing or how many barcodes were tested for recognition).

• Data Provenance: The document generally refers to "performance testing" conducted by STERIS Corporation for their 510(k) submission. It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would typically be prospective, conducted under controlled laboratory conditions to demonstrate performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts used or their qualifications for establishing ground truth, as the ground truth appears to be based on physical biological indicator growth ("7-day grow out") rather than expert review of complex images or data.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the biological indicator test is the physical 7-day grow out, which is an objective measure, not a subjective interpretation requiring adjudication among experts.

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

Not applicable. The Celerity Incubator is a device that automates the reading of biological indicators, not an AI system assisting human readers with interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone Performance (Algorithm Only)

Yes, the testing described appears to be a standalone performance evaluation of the Celerity Incubator's ability to accurately read biological indicators, without human intervention in the reading process itself. The incubator performs the incubation and optical reading automatically.

7. Type of Ground Truth Used

The primary ground truth for the "Qualification Testing with intended Biological Indicators" is 7-day grow out of the biological indicators. This is an objective measure where biological indicators are incubated for a standard 7-day period to definitively determine if microbial growth occurred, which signifies a sterilization failure. The fluorescent reading from the Celerity Incubator is then compared against this established 7-day grow out result. For "Software Validation" and "Recognition of additional barcodes," the ground truth would be based on the intended functional specifications and correct barcode decoding, respectively.

8. Sample Size for the Training Set

Not applicable. This device is an automated incubator and reader, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its function relies on established physical and optical principles for detecting fluorescence, not on learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device in the context of AI/ML.

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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 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization 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 ALL Clear Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾'' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The provided document is a 510(k) premarket notification for a medical device called "CELERITY HP Indicator Tape (PCC077)". It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document states, "No testing was required to verify the labeling change," and clarifies that "The revised labeling is in accordance with recommendations in 'User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry'' April 1, 2003." This implies that the current submission (K242189) is for a labeling change on an existing device, and therefore, no new performance testing was conducted for this specific submission.

The document also refers to the predicate device, K240760, and states that the proposed and predicate devices have "Identical" technological characteristics and performance limitations. This suggests that the performance criteria and related studies would have been established and demonstrated for the predicate device, and since the current device is identical in these aspects (apart from labeling), no new studies are needed.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document, as this submission primarily addresses a labeling change.

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The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.

The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator color changes from the start to the pass color. See reference colors on the bottle.

The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink.

Here's a breakdown of the acceptance criteria and study information for the Celerity Chemical Indicator for enspire 3000 CLCSPS, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • For the Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity, and Analytic Specificity studies (and likely many other studies based on the acceptance criteria phrase "each lot"), 3 lots of the proposed device were tested.
  • The exact number of individual indicators within each lot used for testing is not explicitly stated. However, the acceptance criteria are given as percentages of indicators ("minimum of 75% of indicator from each lot" or "100% of indicators").
• Data Provenance: The document does not specify the country of origin of the data. The studies are non-clinical performance testing, meaning they are laboratory or engineering-based tests, not human subject studies. They are presumably prospective for this submission.

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

• Number of Experts: For the "Post-Processing Stability (Inside Processor) Study" and the "Blind Study," it mentions "inexperienced reader." This implies at least one, and likely more, inexperienced readers were used. It does not state how many experts, if any, were used alongside or to establish ground truth for these readings beyond the "inexperienced reader."
• Qualifications of Experts: The document specifies "inexperienced reader" for certain studies. It does not provide further qualifications for these readers or for any experts involved in establishing ground truth for other tests. For most of the chemical indicator tests, the "ground truth" is intrinsically defined by the chemical conditions (concentration of peracetic acid, temperature, time) to which the indicator is exposed.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for reconciling interpretations from multiple readers. For tests involving "inexperienced readers," it simply states whether "100% CI from each lot correctly interpreted." This suggests a binary outcome (correct/incorrect) without detail on reconciliation if there were multiple readers.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance testing is for a chemical indicator, not a diagnostic imaging device that typically uses MRMC studies. The "Human Factors Study" is mentioned, indicating usability assessment, but not an MRMC study related to diagnostic accuracy improvement.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• This device is a chemical indicator, which is a physical material that changes color based on chemical exposure. It is not an algorithm or software. Therefore, the concept of a "standalone algorithm" study does not apply. Its performance is inherent to the material and its chemical reaction, which is then visually interpreted.

7. Type of Ground Truth Used

• The ground truth for this device is based on defined chemical conditions (e.g., concentration of peracetic acid, exposure time, temperature). For "Pass Conditions" and "Fail Conditions," specific mg/L of peracetic acid (PAA) are used as the reference standard (e.g., ≥2200 mg/L PAA for Pass, 1750-1820 mg/L PAA and 0 mg/L PAA for Fail). This is a highly controlled and objective measure of the chemical environment.

8. Sample Size for the Training Set

• This device is a passive chemical indicator, not an AI/ML algorithm. Therefore, there is no training set in the typical sense used for machine learning models. The device's color change mechanism is based on established chemical principles, not on learned patterns from a dataset.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's design and verification is based on fundamental chemistry and engineering principles for chemical indicators.

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The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

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

· 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.

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The STERIS CELERITY HP Indicator Tape is a chemical indicator designed to distinguish between processed and unprocessed units in various low-temperature sterilization systems using vaporized hydrogen peroxide (VHP).

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 sample sizes used for each specific test (e.g., number of indicator tapes per cycle, number of cycles tested). However, it mentions that "Performance testing was completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design." This suggests that standard testing methodologies, which typically include specific sample size requirements, were followed.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a premarket notification (510(k)) for a medical device to be marketed in the US, the studies were likely conducted to meet US regulatory requirements.

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

This information is not provided in the document. For chemical indicators like the CELERITY HP Indicator Tape, the "ground truth" for successful processing is typically defined by the objective color change criteria specified by the manufacturer and validated against known sterilization conditions (full cycle vs. partial cycle). The interpretation of the color change might be assessed by trained personnel rather than "experts" in the traditional sense, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For a chemical indicator, the color change itself is a direct visual output. Adjudication, if any, would likely involve confirmation that the observed color change aligns with the expected outcome (e.g., full color change for a successful cycle, incomplete for a partial cycle). However, the specific method (e.g., consensus among multiple observers) is not detailed.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret complex data, and the AI's impact on their performance is measured. The CELERITY HP Indicator Tape is a passive chemical indicator with a direct visual output, making an MRMC study irrelevant to its evaluation.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The performance testing (Simulated Use Testing, ISO 11140-1 Testing, Light Stability, Endpoint Stability, Shelf Life) described in the document evaluates the intrinsic behavior and response of the CELERITY HP Indicator Tape itself, independent of human interpretation or assistance beyond observing the color change. The device's performance is determined by its physical and chemical properties and its reaction to sterilization conditions.

7. Type of Ground Truth Used:

The ground truth used for the performance testing is based on:

• Known Sterilization Conditions: The indicators are exposed to "full cycle" and "partial cycle" conditions within specified sterilization systems. A full cycle represents effective sterilization, while a partial cycle represents an insufficient process.
• Adherence to Standards: The "Meets requirement of Type 1 VHP Indicator" for ISO 11140-1 Testing implies that the ground truth for this aspect is defined by the objective performance criteria outlined in the ISO 11140-1 standard for Class 1 chemical indicators. These standards specify how the indicator should react to critical process variables.
• Stability over Time: For light stability and endpoint stability, the ground truth is the expectation that the ink's performance and the endpoint color remain consistent for the labeled period under specified environmental conditions.

8. Sample Size for the Training Set:

This information is not applicable and is not provided in the document. The CELERITY HP Indicator Tape is a chemical indicator, not an AI/ML algorithm that requires a training set. Its design and behavior are based on chemical formulations and physical characteristics, not on learned patterns from a dataset.

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

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

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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 and unprocessed 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, Fast or Specialty 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™ Vaporized | H2O2 Process Indicator Adhesive Label (PI) is to be affixed to the outside of a pack by means of the adhesive back. It is designed to distinguish between processed and unprocessed 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 Fast or Specialty 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 provided text describes a 510(k) premarket notification for a Class II medical device, the Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PCC078). This document primarily focuses on demonstrating substantial equivalence to a predicate device and extending the indications for use.

Based on the provided text, the device is a chemical indicator, not an AI/ML powered device. Therefore, a study proving the device meets AI/ML specific acceptance criteria as you've requested is not applicable here. The information you've asked for regarding acceptance criteria, sample size for test/training sets, expert involvement, and ground truth establishment typically applies to the evaluation of AI/ML models in diagnostic or predictive applications.

However, I can extract information related to the performance evaluation of this chemical indicator, which serves a similar purpose of demonstrating its effectiveness as intended.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this chemical indicator are based on its ability to demonstrate a visible color change from magenta to orange/yellow or lighter when exposed to specific sterilization cycles. The performance is gauged by its visual change and adherence under these conditions.

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

• Sample Size for Test Set: The document does not explicitly state the sample size (number of indicators) used for the testing. It refers to testing previously submitted as part of K231490 for a reference device (VERIFY V24 Self-Contained Biological Indicator). The current submission leverages the equivalence of materials (indicator ink, substrate, adhesive) and the similarity of the V-PRO cycles to claim applicability of the previous testing.
• Data Provenance: Not explicitly stated regarding country of origin. The testing supporting the extended indication (Specialty Cycle) is retrospective, as it refers to data from a previously cleared device (K231490) rather than a new, dedicated prospective study for the Celerity™ label.

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

• This question is not applicable for this type of device. Chemical indicators do not involve human interpretation like medical images that require experts to establish ground truth. Their "ground truth" is their physical chemical reaction (color change) in response to a specific sterilization process. The compliance with standards like ANSI/AAMI/ISO 11140-1:2014 verifies their performance.

4. Adjudication Method for the Test Set

• Not applicable. This device doesn't involve subjective human interpretation of outputs that would require an adjudication method. The outcome is a clear physical change (color).

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 a chemical indicator, not an AI-assisted diagnostic tool. No human "readers" or AI are involved in interpreting its output beyond confirming a color change.

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

• Not applicable. This is a physical chemical indicator, not an algorithm.

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

• The "ground truth" for a chemical indicator is the defined sterilization process parameters (e.g., specific concentrations of VH2O2, exposure times, temperature), and the physical-chemical reaction of the indicator itself when exposed to those parameters. Compliance with international standards (ANSI/AAMI/ISO 11140-1:2014) serves as the primary validation for this ground truth, indicating the device performs as a "Type 1 Process Indicator" (meaning it reacts to the presence of the agent). For the new indication, the ground truth is established by the V-PRO Specialty Cycle parameters and the observed, expected color change of the indicator within these parameters, leveraging prior testing equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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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 or lighter, when the device has been exposed to the:

• · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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™ HP Multivariable Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

• Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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 VERIFY® HPU 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 to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization 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.
• 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 without ALLClear.

The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 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/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.

The Celerity™ HP Multivariable Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for Specialty cycle.

The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.

The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The provided text describes premarket notification (510(k)) submissions for four chemical indicators (CIs) used in sterilization processes:

1. Celerity™ HP Chemical Indicator (CI) (K231488) on pages 3-5.
2. Celerity™ HP Multivariable Chemical Indicator (CI) (K231488) on pages 6-9.
3. VERIFY HPU Chemical Indicator (CI) (K231488) on pages 10-12.
4. VERIFY VH2O2 Indicator Tape (K231488) on pages 13-16.

For each of these devices, the core purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily by showing that the indicators function as intended even with an expanded "Indications for Use" to include the "Specialty" sterilization cycle of the V-PRO® Low Temperature Sterilization System.

The information provided does not pertain to a medical device that uses AI or machine learning, nor does it involve human readers/experts interpreting medical images. Instead, it describes performance testing of chemical indicators, which are physical objects designed to change color under specific sterilization conditions. Therefore, the requested information elements such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Effect size of human readers improvement with AI," "Stand-alone algorithm performance," "Training set sample size," and "How ground truth for training set was established" are not applicable to this type of device and study.

The acceptance criteria and reported performance for each device are derived from "Simulated Use Testing" and are consistently focused on the physical color change and the indicator's integrity.

Here's a summary of the relevant information provided for each product:

1. Celerity™ HP Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated, but the context implies a sufficient number of indicators were tested to demonstrate consistent performance.
• Data Provenance: Not explicitly stated, but the manufacturing facility is in the United Kingdom, and the testing simulates "typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle." This suggests laboratory-based, prospective testing designed to validate performance under specified conditions.
• Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, indicating that the sterilization conditions were met. This is a direct physical outcome.

2. Celerity™ HP Multivariable Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but similar to the previous Celerity CI, implies laboratory-based, prospective testing.
• Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, confirming proper function as a multivariable indicator.

3. VERIFY HPU Chemical Indicator (CI) (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing.
• Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator (magenta to yellow) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.

4. VERIFY VH2O2 Indicator Tape (K231488)

Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing. The manufacturing facility is in Buena Park, CA (USA).
• Type of Ground Truth: The ground truth is the physical observation of the color change of the indicator tape (pink to peach, yellow or lighter) and its physical integrity (remaining adhered) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.

Summary of non-applicable AI/ML specific criteria:

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is based on physical/chemical reaction.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of complex data; rather, direct observation of state change.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical chemical indicator, not an algorithm.
• The sample size for the training set: Not applicable. These are physical devices, not AI models requiring training data.
• How the ground truth for the training set was established: Not applicable for the same reason.

In all cases, the primary purpose of the testing described is to confirm that the chemical indicators reliably undergo the expected color change (and adhere, for the tape) when exposed to the specific V-PRO maX 2 Sterilizer Specialty cycle, thereby demonstrating their continued safety and effectiveness for an expanded indication.

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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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Celerity 5 HP Biological Indicator: The Celerity 5 HP Biological Indicator (BI) is used 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, 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® · 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 5 HP 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, 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 (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 5 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 2 hours prior to activation. The BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60 ℃ in the CELERITY Incubator for a final determination of viability within 5 minutes of incubation.

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

Device: Celerity 5 HP Biological Indicator and Celerity 5 HP Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily describes non-clinical tests performed to demonstrate substantial equivalence. It does not provide specific sample sizes for "test sets" in the context of human-involved studies (e.g., retrospective or prospective patient data). The evaluation appears to be based on laboratory testing of the biological indicators themselves.

• Sample Size: Not specified in terms of number of "cases" or patient data points. The tests likely involved multiple units of the biological indicator and challenge pack.
• Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (STERIS Corporation). Therefore, there is no country of origin of patient data, nor is it retrospective or prospective in the medical imaging sense.

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

Not applicable. The "ground truth" for a biological indicator is based on microbiological assays (e.g., spore viability, D-value, kill time) and engineered test conditions, rather than expert interpretation of medical images or pathologies.

4. Adjudication Method for the Test Set:

Not applicable. As the tests are non-clinical and objective (e.g., measuring spore population, observing growth/no growth), there is no need for expert adjudication.

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

Not applicable. This device is a biological indicator for monitoring sterilization processes, not a medical imaging or diagnostic device that involves human readers.

• Effect Size: Not applicable.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

The device is a standalone biological indicator that produces a result (fluorescent signal) which is then read by the Celerity® Incubator. While humans initiate the process and interpret the incubator's output, the "performance" described in the tests (e.g., D-value, kill time, signal generation) refers to the intrinsic behavior of the biological indicator. In this sense, the tests demonstrate the standalone performance of the BI.

7. Type of Ground Truth Used:

The ground truth used is primarily microbiological and physical measurements based on established standards for biological indicators. This includes:

• Spore population counts: Direct enumeration of viable spores.
• D-value determination: A measure of the resistance of microorganisms to a sterilizing agent.
• Survival and kill times: Time points at which a specified percentage of organisms survive or are killed.
• Growth/no growth observations: The fundamental output of a biological indicator.
• Fluorescent signal detection: Objective detection by the incubator.
• Worst-case sterilization conditions: Established laboratory parameters to rigorously challenge the device's performance.

8. Sample Size for the Training Set:

Not applicable. This device is a physical biological indicator, not an AI/machine learning algorithm that requires a training set of data.

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

Not applicable (as it's not an AI/ML device).

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