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The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.

The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft).

The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are based on the ability to achieve sterilization of various loads under specified cycle parameters, and dryness of the load where applicable. The study proving the device meets these criteria involved comprehensive performance testing conforming to industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are implicitly defined by the successful demonstration of:

• Achieving a sterility assurance level (SAL) of at least 10^-6.
• Complete kill of biological indicators (BIs).
• Moisture retention within specified limits for fabric and wrapped instrument packs.
• Successful Bowie-Dick test for air removal.
• Maintaining steady-state thermal conditions within the chamber.
• Water loss not exceeding 50ml for liquid loads.

The reported device performance, demonstrated through validation testing against these criteria, confirmed that the sterilizer performs as intended.

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

The document does not explicitly state a numerical "sample size" in terms of number of sterilizer units tested or specific quantities of test cycles beyond stating "all cycles were validated." However, the testing was performed for each cycle type available on the Getinge 700HC-E Series Steam Sterilizer, for all three chamber sizes (39 inch, 53 inch, 61 inch), and for various load configurations as detailed in the "Cycles and Load Chart."

• Test Sets: The "test set" consisted of various "process challenge devices" and load configurations specified by ANSI/AAMI ST8:2008, including:
  • Fabric process challenge packs
  • Wrapped instrument process challenge devices
  • Unwrapped non-porous process challenge devices
  • 3 one-liter flasks for liquid load cycles
  • Bowie-Dick test packs
  • Empty chambers for thermal mapping.
• Data Provenance: The testing was performed according to "industry standards and guidelines," specifically referencing ANSI/AAMI ST8:2008, which is a standard applicable within the United States. The testing appears to be prospective as it validates the performance of the new device model.

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

The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set. Instead, the ground truth is established by objective, standardized methods and criteria defined by the ANSI/AAMI ST8:2008 standard and the expected biological and physical outcomes of sterilization. For example, "complete kill of biological indicators" is an objective, measurable outcome.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the performance testing is determined by objective measurements (e.g., direct observation of BI growth, temperature recordings, weight measurements) against pre-defined thresholds from the ANSI/AAMI ST8:2008 standard, rather than subjective expert 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 medical device (steam sterilizer), not an AI/imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is a steam sterilizer, not an algorithm. However, the performance testing described is analogous to a "standalone" performance evaluation of the device itself, as it assesses the sterilizer's function without human intervention beyond operation and monitoring.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on:

• Biological Indicators (BIs): Used to confirm the destruction of resistant microorganisms, providing a direct measure of microbial inactivation (sterility assurance).
• Physical Measurements:
  • Temperature and Time: Achievement of specific temperature and exposure time combinations (expressed as F0 value) within the chamber and load.
  • Weight Measurement: To assess moisture retention in fabric and wrapped instrument packs.
  • Volume Measurement: To assess water loss in liquid loads.
• Chemical Indicators (Bowie-Dick Test): Used to detect air removal efficacy in dynamic-air-removal steam sterilizers.
• Industry Standards: Adherence to the criteria and methodologies outlined in ANSI/AAMI ST8:2008 for "Hospital Steam Sterilizers."

8. The Sample Size for the Training Set

Not applicable. This device is a classic medical device (steam sterilizer) and does not involve machine learning or AI, and therefore does not have a "training set." The listed cycles and load configurations were extensively tested as part of the validation, representing the complete range of intended uses.

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

Not applicable, as no training set was used.

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