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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 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 3 hour cycle at 50°C in the EOGas 4 Ethylene Oxide sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.01 (115V) or AN4000.11 (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. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN1087 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest) that is integrated into the sterilizer.

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

Acceptance Criteria and Reported Device Performance

• 24 lbs (11 kg) of metal instruments (with or without mated surfaces).
• 6.1 lbs (2.8 kg) of fabric.
• 7.0 lbs (3.2 kg) of plastic devices.
• Four 1.2 x 700 mm endoscopes or one 2 x 1100 mm endoscope. |
  | Process Challenge Device (PCD) Resistance: The resistance characteristics of the Andersen process challenge device (AN7408.14) must be greater than the same biological indicator (BI) placed in the worst-case location in each of the worst-case validation loads. | The resistance characteristics of the AN7408.14 are greater than the same BI placed in the worst-case location in each of the worst-case validation loads. |
  | Residuals (EO and ECH): Ethylene oxide (EO) or ethylene chlorohydrin (ECH) residuals remaining on even the most absorbent materials tested must meet the requirements of AAMI/ANSI/ISO 10993-7. | The majority of EO or ECH residuals met the requirements of AAMI/ANSI/ISO 10993-7. |
  | Electromagnetic Compatibility (EMC) and Electrical Safety: Verify compliance with requirements for EMC and electrical safety. | The device was tested to verify compliance with requirements for EMC and electrical safety. |
  | Physical Performance: EOGas 4 Ethylene Oxide Gas Sterilizer, EOGas cartridges, sterilization bags, and Humidichips must meet their performance specifications. | The device and accessories met their performance specifications. |
  | Cycle Specification Maintenance: The EOGas 4 sterilization system must achieve and maintain cycle specifications for EO concentration, temperature, time, and relative humidity. | The system achieved and maintained cycle specifications for EO concentration, temperature, time, and relative humidity. |
  | Repeatability and Reliability: The 3-hour cycle at 50°C must be repeatable and reliable under the indicated test load conditions. | The 3-hour cycle at 50°C was repeatable and reliable under the indicated test load conditions. |

Study Information

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

   • Test Set Sample Size:
     • Metal: 24 lbs (11 kg)
     • Plastic: 7.0 lbs (3.2 kg)
     • Fabric: 6.1 lbs (2.8 kg)
     • Single-lumen Endoscopes: One (1) ≥ 2.0mm ID ≤ 1100mm length OR Four (4) ≥ 1.2 mm ID ≤ 700 mm length.
     • The document states "All validated maximum loads were processed without additional devices in the sterilizer." This implies discrete tests for each load type.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the nature of equipment validation for FDA approval typically involves prospective, controlled laboratory testing.

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

   • The document does not specify the number or qualifications of experts used to establish the ground truth. Sterilization validation typically relies on established scientific methods (e.g., biological indicators, chemical indicators, physical monitors) rather than expert consensus on individual results, although experts would design and review the validation protocols.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method in the context of human expert review. The "ground truth" for sterilization is determined by the inactivation of biological indicators and adherence to SAL, verified through laboratory methods.

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:

   • No. This is a sterilization device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and AI assistance comparisons are not applicable.

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

   • Yes, effectively. The "standalone" performance in this context refers to the sterilizer's ability to achieve sterility without human intervention during the sterilization cycle itself. The validation testing described (achieving SAL of 10⁻⁶, effective sterilization of loads, meeting residuals, etc.) directly assesses the standalone performance of the device. Human operators perform pre-processing (cleaning, loading) and post-processing (unloading, aeration, biological indicator interpretation), but the sterilization process is automated by the device.

6. The type of ground truth used:

   • Biological Indicators (BIs): Specifically, Bacillus atrophaeus biological indicators (AN2203) are mentioned, inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest). The inactivation of these resistant microorganisms serves as the primary "ground truth" for sterility.
   • Simulated-use testing: This involved using instruments with mated surfaces and endoscope lumens, confirming effectiveness in conditions mimicking actual use.
   • In-use testing: Confirmed the ability of the cycle to sterilize single-lumen endoscopes used clinically in a hospital setting.
   • Chemical Analysis: Process residue analysis for EO and ECH residuals against AAMI/ANSI/ISO 10993-7 standards.
   • Physical Monitoring: Verification of EO concentration, temperature, time, and relative humidity.

7. The sample size for the training set:

   • This concept is not applicable here as this is not a machine learning or AI device. The validation involves testing against predefined loads and parameters, not "training" a model.

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

   • As this is not a machine learning device, the concept of a "training set" and its ground truth establishment does not apply. The device's performance is validated through direct empirical testing against established sterilization standards.

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