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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.

Device Description

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.

AI/ML Overview

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)

Test	Acceptance Criteria	Reported Device Performance (Result)
Reduced Incubation Time Testing	All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5-minutes.	PASS
Simulated Use Testing	All processed BIs shall be sterile following full cycle exposure sterilizer cycles.	PASS
Bacteriostasis Testing	All BIs inoculated with 10-100 Geobacillus stearothermophilus spores will demonstrate growth.	PASS
Cap Media Testing	All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Stability Testing	Population: The mean initial population at the start of the stability study must be 1.0-4.0 x 10^6 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.
D-value: D-value between 6 and 20 seconds.
Survival/Kill: Demonstration of one all survive time and one all kill time point.
RIT: All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5 minutes.
Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Specialty Cycle	All BIs will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.	PASS
Hold Time Testing	The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).	72 Hour Hold Time Established

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

Test	Acceptance Criteria	Reported Device Performance (Result)
Reduced Incubation Time Testing	All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.	PASS
Simulated Use Testing	All processed BIs shall be sterile following full cycle exposure sterilizer cycles.	PASS
Bacteriostasis Testing	All BIs inoculated with 10-100 Geobacillus stearothermophilus spores will demonstrate growth.	PASS
Cap Media Testing	All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Stability Testing	Population: The mean initial population at the start of the stability study must be 1.0-4.0 x 10^6 CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population.
D-value: D-value between 6 and 20 seconds.
Survival/Kill: Demonstration of one all survive time and one all kill time point.
RIT: All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes.
Media Testing: All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators.	PASS
Specialty Cycle	All BIs will demonstrate a positive signal and growth after exposure to a sublethal cycle and a 20 hour aeration phase.	Pass
Hold Time Testing	The hold time will be established using the longest hold time where there is no statistical or practical difference from the initial hold time (time 0).	72 Hour Hold Time Established

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.

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.
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.
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.
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 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.
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.
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.
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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