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The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on the purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator (RRBI) consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOCas 4 Ethylene Oxide Gas Sterilizer.

The Bionova BT110 Rapid Readout Biological Indicator (K191021) consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing culture medium and a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.

Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.

The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).

The provided document describes the EOGas 4 Endo-SteriTest RRBI, a rapid readout biological indicator for monitoring ethylene oxide sterilization cycles. The submission seeks to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The document explicitly lists "Functionality" and "Shelf Life" tests with their acceptance criteria and "Pass" results.
• For the individual studies performed for the Bionova BT110 Rapid Readout Biological Indicators (which is a component of the EOGas 4 Endo-SteriTest RRBI), the document states that "The results of all studies met the established acceptance criteria," without enumerating the specific criteria for each.

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

The document does not provide specific sample sizes (e.g., number of BIs or sterilization cycles) for the "test set" studies. It mentions that "The EOGas 4 Endo-SteriTest RRBI has been validated using applicable tests in FDA 2007 'Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions', and ANSI/AAMI/ISO 11138-1:2017 'Sterilization of health care products -Biological indicators - Part 1: General requirements'." These standards typically define the requirements for testing, including sample sizes, but the specific numbers used in this submission are not stated.

Data provenance is not explicitly mentioned but is assumed to be prospective bench testing conducted by the manufacturer as part of the validation process for regulatory submission. There is no mention of country of origin for data.

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

Not applicable. This device is a biological indicator designed to directly measure sterilization efficacy, not to be interpreted by human experts like medical images. The "ground truth" for a biological indicator is the direct observation of microbial growth (or lack thereof) after exposure to a sterilization process, relative to positive and negative controls.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the device's output (microbial growth/no growth, or fluorescent activity/no fluorescent activity) is a direct, objective measurement, not subject to subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is not an AI algorithm. The device itself (the biological indicator) is a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth used for biological indicators is the viability of the Bacillus atrophaeus bacterial spores.

• Failed Sterilization: Indicated by observable fluorescent activity or a color change from blue to yellow in the culture medium, signifying spore survival and growth.
• Successful Sterilization: Indicated by no fluorescence and no color change, signifying spore inactivation.
• Positive controls (unprocessed BIs) are expected to show growth, and negative controls (processed BIs from a successful cycle) are expected to show no growth, confirming the validity of the test.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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The EOGas 4 Ethylene Oxide Gas Sterilize is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.60 (115V) or AN4000.61 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag.

Here's a summary of the acceptance criteria and study information for the EOGas 4 Ethylene Oxide Gas Sterilizer, based on the provided document:

Acceptance Criteria and Device Performance

Study Information:

1. Sample sizes used for the test set and data provenance:

   • Minimum Sterilization Parameters: Performed to define and validate the endoscope loads. The results indicate successful inactivation of 6-Log BIs for "two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load." The exact number of each type of load tested isn't specified, but implies multiple runs for different combinations.
   • Half Dose Validation: "Consecutive half dose cycles and full dose cycles were performed." No specific number of cycles or endoscopes is provided.
   • Simulated-Use Testing: "Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested." Again, the exact number of cycles or endoscopes is not specified.
   • In-Use Testing: "Duodenoscopes and colonoscopes, used on patients... processed using the 6-hour EO exposure." No specific number of patient-used scopes is provided.
   • EO Residuals: Tested on "Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes" and "Fujifilm ED-530XT and EC-600HL." This indicates testing on a variety of endoscope models.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S., the testing would typically be conducted to U.S. regulatory standards. "In-Use Testing" mentions "used in routine endoscopic procedures in a hospital or clinic setting," suggesting prospective collection of real-world use data.

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

   • This document describes performance testing of a sterilizer, where the "ground truth" is defined by the inactivation of biological indicators and the adherence to specified chemical and physical parameters. These are objective measures and do not typically involve human "experts" establishing a subjective ground truth, as would be the case for image interpretation or diagnosis. Therefore, no information on experts for ground truth is applicable or provided.

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

   • Not applicable. As noted above, the ground truth is based on objective laboratory measurements (biological indicator cultures, chemical concentrations, temperature, humidity, and residual levels), not a subjective human assessment 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 document pertains to the validation of an ethylene oxide gas sterilizer, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

   • Not applicable. This device is a sterilizer, not an algorithm. Its performance is evaluated through its physical and biological sterilization capabilities.

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

   • The ground truth for the sterilization efficacy tests is primarily established by:
     • Biological Inactivation: The complete inactivation of 6-Log Bacillus atrophaeus biological indicators, confirmed by culture methods.
     • Physical Parameters: Measurement of critical process parameters (EO concentration, temperature, relative humidity, time) meeting defined specifications.
     • Chemical Residuals: Measurement of ethylene oxide residuals meeting ANSI/AAMI/ISO 10993-7 requirements.
     • Sterility Testing: For in-use testing, sterility was confirmed by a flush method per USP, indicating no microbial growth.

7. The sample size for the training set:

   • Not applicable. This device is a physical sterilizer and does not involve AI or machine learning models that require a training set.

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

   • Not applicable, as no training set is used for this type of device validation.

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The EOGas 4 Endo-SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on a gold-colored purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The EOGas 4 Endo-SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer.

The SCBI, the EZTest-Gas Biological Indicator, consists of a plastic vial that serves as the culture tube, and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.

Following manufacturer's instructions, the operator inserts the EZTest-Gas Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50℃. After cycle completion, the EZTest-Gas Biological Indicator is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30- 35°C for 48 hours and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).

The provided text describes the acceptance criteria and the results of studies conducted for the EOGas 4 Endo-SteriTest, a biological indicator for ethylene oxide sterilization.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes (number of biological indicators, number of runs, etc.) for each individual test. It mentions that "lots of biological indicators" were tested for D-value comparison, and refers to "half dose cycles" and "full dose cycles" for the half-dose validation. It does not provide information on the country of origin or whether the data was retrospective or prospective.

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

Not applicable. This device is a biological indicator for sterilization. Its performance is evaluated through microbial growth/inactivation and chemical indicator changes, not by human expert interpretation of images or other data typically requiring expert consensus.

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

Not applicable. The ground truth for this device is based on objective biological and chemical responses, not subjective expert judgment that would require 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 a biological indicator for monitoring sterilization efficacy, not an AI-assisted diagnostic device that involves human readers.

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

This is a standalone device in the context of it generating its own result (color change, microbial growth/no growth). Its performance is evaluated directly through its biological and chemical responses to sterilization conditions, independent of human intervention for its core function.

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

The ground truth used for this biological indicator is primarily the inactivation or survival of Bacillus atrophaeus bacterial spores when subjected to defined sterilization conditions, and the physical/chemical change of an indicator. This is an objective, measurable biological and chemical response, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth establishment process in that context. The "ground truth" for evaluating the BI's performance is established by microbiological standards for spore inactivation.

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AN1036 Dosimeter is a single-use color change chemical indicator. It is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in a 3-hour or 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.

The AN1036 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 4 Ethylene Oxide Gas Sterilizer.

The AN1036 Dosimeter contains a proprietary pH indicator in a glass capillary tube that is sealed on one end and mounted on a plastic tray. It is calibrated for a 50℃ sterilization temperature and responds to ethylene oxide concentration and sterilization time. With exposure to ethylene oxide, the indicator turns from yellow-orange to a dark blue color from the open end toward the closed end. The extent of the color change is proportional to cumulative ethylene oxide exposure. The cycle-specific calibration marks represent adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN1036 Dosimeter after 3-hour gas exposures or at the center of the endoscope lumens after 6-hour gas exposures. The AN1036 Dosimeter is not a replacement for a biological indicator.

Here's a summary of the acceptance criteria and study information for the AN1036 Dosimeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a specific numerical sample size for the test set used in the "Chemical Indicator" performance evaluation. It mentions that "AN1036 Dosimeters correctly indicate pass/fail in various endoscope loads."
• Data Provenance: The studies were conducted by Andersen Sterilizers, Inc. as part of their 510(k) submission. The data is retrospective in the sense that it's a report of completed testing, but it's not specified if the data itself was collected retrospectively from past clinical cases or specifically generated for this submission through controlled laboratory experiments. Given the nature of a chemical indicator, it's highly likely it was generated through controlled laboratory testing. The country of origin for the data is implicitly the United States, as Andersen Sterilizers, Inc. is located in North Carolina, and the submission is to the FDA.

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

• This information is not provided in the document. The "ground truth" for a chemical indicator's performance would typically be established based on instrumental measurements of ethylene oxide concentration, temperature, and time parameters, and the known biological inactivation levels corresponding to those parameters, rather than expert interpretation of the indicator itself.

4. Adjudication method for the test set:

• This information is not explicitly provided. For a chemical indicator, the "adjudication" would likely involve objective measurements and comparison against established physical/chemical standards, rather than a human consensus process.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is involved. The AN1036 Dosimeter is a chemical indicator, not an AI device.

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

• This question is not applicable. The AN1036 Dosimeter is a chemical indicator that works passively based on chemical reactions. It is not an algorithm or an AI system that performs independently.

7. The type of ground truth used:

• The ground truth for the "Chemical Indicator" test is based on the proper functioning of the EOGas 4 Ethylene Oxide Gas Sterilizer under specified critical parameters (Ethylene Oxide concentration, Temperature, Relative Humidity, EO Exposure Time, Total Cycle Time). The indicator's response (extent of color change) is correlated with "adequate cumulative EO exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator." This implies a biological indicator equivalency as the ultimate ground truth, verified under controlled physical and chemical parameters.

8. The sample size for the training set:

• This information is not applicable. The AN1036 Dosimeter is a physical chemical indicator, not a machine learning model that requires a training set.

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

• This information is not applicable, as there is no training set for a chemical indicator.

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Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene-vinyl acetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heatsealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85 EO Indicators, when placed on the outside of the sterilization pouches. indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.

The provided document is a 510(k) premarket notification for a medical device (Tyvek Sterilization Pouches with Chevron Seal), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML-driven device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this document.

This submission is for a physical product (sterilization pouches) and details non-clinical performance testing related to its material properties, sterilization efficacy, and shelf life, not an AI/ML algorithm.

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Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Sterisheet Sterilization Wraps are single use, non-sterilyzation wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month.

AN85 EO Indicators, when placed on the outside of the sterilization wraps, may be used to secure the wrapping material on the devices and to indicate ethylene oxide exposure, offering a convenient way to verify processing in the sterilization cycle. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.

The information provided describes the acceptance criteria and a summary of non-clinical testing for the Sterisheet Sterilization Wrap (K200335), which is intended for use in a 6-hour ethylene oxide (EO) gas sterilization cycle.

Here's an analysis of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "Performance Testing" and "Summary of bench tests" but does not provide details on specific sample sizes for these tests. It indicates that the tests conform to ISO 11607-1, ASTM F2101, DIN 58953-6, ISO 10993, and USP standards. These are bench-level tests (non-clinical) and do not involve human subjects or geographical data provenance in the typical sense. The testing was conducted to prove the performance of the wrap itself.

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)

This information is not applicable as the study described is a non-clinical performance evaluation of a sterilization wrap, not a diagnostic device relying on expert interpretation for ground truth. The "ground truth" here is the outcome of standardized physical, chemical, and biological tests.

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

This information is not applicable as the tests are objective laboratory tests rather than subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as MRMC studies are relevant for diagnostic tools, particularly those involving human interpretation of medical images or data, often with AI assistance. The Sterisheet Sterilization Wrap is a medical device for sterilization, not a diagnostic or AI-powered interpretative tool.

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

This information is not applicable for the same reasons as above. The device is not an algorithm. The "standalone" performance here refers to the wrap's inherent ability to function as a microbial barrier and allow sterilant penetration.

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

The ground truth for the non-clinical tests is established through objective laboratory measurements and validated biological indicators. For example:

• Physical and Chemical Properties: Measured values against established standards (e.g., ISO for substance, permeability).
• Bacterial Filtration Efficiency and Germ Proofness: Efficacy in preventing microbial passage according to ASTM and DIN standards.
• Material Compatibility: Physical, chemical, and microbial barrier properties remaining acceptable after EO exposure.
• Biocompatibility: Absence of toxicity per ISO 10993 and USP (MEM Elution, Sensitization, Irritation).
• Sterilant Penetration: Inactivation of 6-Log biological indicators.
• Maintenance of Package Sterility: Absence of microorganism growth after storage.

8. The sample size for the training set

This information is not applicable. The Sterisheet Sterilization Wrap is not an AI/ML device that requires a "training set." The tests are empirical demonstrations of its physical, chemical, and biological performance.

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

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

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AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.

The AN87 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

The AN87 Dosimeter contains a proprietary pH indicator in a glass capillary tube that is sealed on one end and mounted on a plastic tray. It is calibrated for a 20-29°C sterilization temperature, and responds to ethylene oxide concentration and sterilization time. With exposure to ethylene oxide, the indicator turns from yellow-orange to a dark blue color from the open end toward the closed end. The extent of the color change is proportional to the cumulative ethylene oxide exposure. The calibration mark represents adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN87 Dosimeter. The AN87 Dosimeter is not a replacement for a biological indicator.

The provided text describes the AN87 Dosimeter, a single-use chemical indicator for verifying adequate cumulative ethylene oxide exposure in the Anprolene AN75 Ethylene Oxide Gas sterilizer. The device is claimed to be substantially equivalent to the predicate AN1087 Dosimeter (K150645).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance testing described in section 5.9 of the 510(k) summary, specifically from Table 5-3.

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

The document does not specify the sample size used for the test set for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin). The testing was conducted by Andersen Sterilizers, Inc., the manufacturer, implying internal data collection. The tests sound like prospective laboratory experiments rather than retrospective analysis of existing data.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication method for the test set

The document does not describe any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.

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

Yes, standalone performance testing was done. The device itself (the AN87 Dosimeter, which is a chemical indicator and not an algorithm in the typical software sense) provides a direct visual indication (color change). The performance tests described characterize the device's ability to accurately reflect cumulative EO exposure without human interpretation beyond observing the color change against a calibration mark. The "algorithm" here is the chemical reaction itself.

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

The ground truth for the functionality testing was established by correlating the AN87 Dosimeter's color change with:

• The critical process parameters of the sterilization cycle (temperature, time, gas concentration, humidity).
• The performance of a 6-Log Bacillus atrophaeus biological indicator, which is a widely accepted standard for demonstrating sterilization efficacy. This acts as the direct ground truth for sterilization effectiveness.

8. The sample size for the training set

The concept of a "training set" is not applicable in the context of this chemical indicator. Chemical indicators operate based on predetermined chemical reactions and calibration, not machine learning or AI models that require training data.

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. The device's calibration and performance are validated against physical and biological standards.

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The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.

The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces.

The Anprolene AN75 Ethylene Oxide Gas Sterilizers, model numbers AN75i (AN75.64 and AN75.65), AN75iX (AN75.84 and AN75.85), and AN75J (AN75.74 and AN75.75), are intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN87 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7508.14 Anprolene SteriTest) that is integrated into the sterilizer.

This document describes the Anprolene AN75 Ethylene Oxide Gas Sterilizer, its indications for use, and a comparison to predicate devices, along with performance testing.

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 a numerical sample size for the "test set" in terms of specific units tested. However, it indicates:

• "The maximum loads of metal, fabric, and plastic devices that may be routinely sterilized in the Anprolene AN75 Ethylene Oxide Gas Sterilizer were defined and validated."
• "All validated maximum loads were processed without additional devices in the sterilizer."
• "The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of $10^{-6}$ for surfaces, including mated surfaces."
• "The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces."

The data provenance is not explicitly mentioned (e.g., country of origin). The study appears to be prospective validation testing conducted by the manufacturer to demonstrate the sterilizer's performance according to established guidelines.

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

This information is not provided in the document. The "ground truth" for sterilization effectiveness is typically established through recognized biological indicators and laboratory analyses, rather than expert human assessment for individual sterilization cycles.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves objective performance metrics (e.g., SAL achievement, residual levels, physical parameters) rather than subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an ethylene oxide gas sterilizer, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

This is not applicable. The device is a physical sterilizer, not an algorithm. The performance evaluation focuses on the sterilizer's ability to achieve sterility without human intervention on a per-cycle basis, beyond loading and operating the device following instructions.

7. The Type of Ground Truth Used

The ground truth used for assessing the sterilization effectiveness primarily relies on:

• Sterility Assurance Level (SAL) of $10^{-6}$: This is a widely accepted microbiological standard for sterilization, achieved through the inactivation of biological indicators.
• Inactivation of an EZTest®- Gas Biological Indicator: Specifically, the document mentions "successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device."
• AAMI/ANSI/ISO 10993-7: For process residue analysis, ground truth is based on meeting the requirements of this standard for ethylene oxide residuals.
• Physical Performance Specifications: For the sterilizer components, cartridges, and bags, ground truth is adherence to predetermined physical performance specifications (e.g., EO amount, concentration, temperature, relative humidity, electrical safety).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical sterilizer and not an AI/machine learning model, so there is no "training set" in that context. The validation involves testing the physical device's performance under various conditions and loads.

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

This information is not applicable for the same reasons as point 8.

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Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylenevinylacetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days).

The provided text describes the acceptance criteria and the study proving the device meets these criteria for Tyvek Sterilization Pouches with Chevron Seal (K170429), when used with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Here's the breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test (e.g., number of pouches tested for seal strength, microbial barrier, etc.). It refers to "performance testing" and "studies" but doesn't quantify the number of units/samples used in these tests.

• Data Provenance: The context of the document (FDA 510(k) submission) implies these studies were conducted by the manufacturer, Andersen Sterilizers, Inc., likely in the United States (their address is Haw River, North Carolina). The studies appear to be prospective in nature, designed to demonstrate the safety and effectiveness of the device for the specific new indication (use with Anprolene AN75).

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)

This information is not provided in the document. The studies described are primarily bench tests and performance testing against industry standards (ISO, ASTM) and internal validation. They do not involve expert human interpretation of data in the same way a diagnostic AI device would. "Ground truth" here is established through scientific testing methods (e.g., biological indicator inactivation for sterility, physical property measurements for package integrity).

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

This is not applicable as the evaluation of this device is based on objective physical and microbiological test results, not on human interpretation or consensus. Therefore, no adjudication method was used or needed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a sterilization pouch, not an AI or diagnostic imaging device. Therefore, MRMC studies involving human readers are not relevant.

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

Not applicable. This device is a medical device product, not a software algorithm. The "performance" described is purely the physical and biological efficacy of the pouch itself in the sterilization process, independent of human interpretation or automated algorithms.

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

The ground truth for this device's performance is established through objective scientific measurements and standardized testing methodologies, including:

• Microbiological testing: Such as microbial aerosol challenge tests and biological indicator inactivation assays to demonstrate sterility assurance levels.
• Physical property testing: Measurements of seal strength, burst strength, and peel open characteristics to assess package integrity.
• Chemical/Material analysis: To confirm material compatibility and biocompatibility against established standards (e.g., ISO 11607-1).
• Time-based stability testing: To demonstrate shelf life and maintenance of sterility over time.

8. The sample size for the training set

Not applicable. This device is a physical product (sterilization pouch), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML development.

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

Not applicable for the same reason as point 8.

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