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The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.

Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in seven separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs, inclusive of the containers/packaging weight but excluding the 25 Ibs loading rack.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, single-channel flexible endoscopes, and rigid-channel devices including single-channel and double-channel rigid endoscopes.

The VP4 has been modified in order to make it compliant with the European Directive on the Restriction Of use of certain Hazardous Substances also known as « RoHS ». In addition, device software has been modified to include a maintenance mode, among other small changes. Finally, a new sensor has been adopted for monitor and control of chamber pressure.

Here's a breakdown of the acceptance criteria and study information for the STERIZONE® VP4 Sterilizer, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of a sterility assurance level (SAL) of 10^-6, which is a standard for sterilization effectiveness. The "overkill" approach used in testing suggests that the device's performance exceeds this minimum requirement.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The test set for demonstrating sterilization efficacy consisted of a "representative sample of one or more device types and packaging, in seven separate validation loads." The details of these loads are provided in Table 1 (pages 2-3 and 5-6). For example:
  • Load 1: General medical instruments (e.g., clamp, serrated surface, box-lock) – 11 lb load.
  • Load 3: Three single-channel flexible endoscopes + eight general medical instruments – 23 lb load.
  • Load 4: Up to 15 rigid or semi-rigid channeled instruments + two general medical instruments – 19 lb load.
  • Load 7: General medical instruments – 75 lb load.
• Data Provenance: The document (page 4) states the applicant's name and address as TSO3 Inc., Quebec, QC, Canada. This indicates the testing and data likely originated from Canada, although the exact location of the testing facility is not specified. The study is prospective as it involves performance validation testing of the STERIZONE® VP4 Sterilizer to demonstrate its effectiveness.

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

This information is not provided in the document. The study focuses on the physical and biological efficacy of a sterilizer, not on interpretation by human experts. The "ground truth" for sterilization is typically established through standard microbiological methods (e.g., biological indicators, culturing) demonstrating the absence of viable microorganisms.

4. Adjudication Method for the Test Set

This is not applicable as the study does not involve subjective human assessment requiring adjudication. The assessment of sterilization efficacy is based on objective biological and physical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The STERIZONE® VP4 Sterilizer is a sterilization device, and its performance is evaluated by its ability to sterilize, not by human interpretation of its output.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Yes, a standalone performance study was done. The document explicitly states: "The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process." This describes the algorithm (sterilization process) acting independently to achieve sterility. The efficacy is demonstrated by achieving a 10^-6 SAL, inherently a standalone performance metric.

7. Type of Ground Truth Used

The ground truth used for demonstrating sterilization efficacy is microbiological (biological indicators). The "overkill approach" and "achievement of a sterility assurance level (SAL) of 10^-6" directly refer to the statistical probability of a single viable microorganism remaining after sterilization, which is determined through testing with highly resistant bacterial spores (biological indicators).

8. Sample Size for the Training Set

This information is not explicitly provided in the document. The document describes verification and validation testing for the modified device, but does not detail a separate "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML model development. While the device contains software, the efficacy testing described is typical for a medical device sterilizer, where robust physical and biological challenge tests are performed, rather than machine learning model training.

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

As no explicit "training set" in the machine learning sense is described, this information is not applicable. The ground truth for the performance validation (test set equivalent) was established through microbiological methods using biological indicators to confirm sterility, typically following established standards for sterilization validation.

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