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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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