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The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.

Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).

| Cycle | Temperature
(°C) | Pressure
(bar) | Exposure
Time (min.) | Drying Time
(min.) | Maximum
Load (kg) |
|---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------|
| Unwrapped
instruments* | 134 | 2.14 – 2.21 | 4 | 6 | 4.0 |
| Wrapped
instruments** | 134 | 2.14 – 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |

• Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)

** Dental handpieces can be processed in the Wrapped instruments cycle only

The sterilizer is not intended to sterilize patient-contacting liquids.

The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Sterilizer is provided with a diaphragm compressor and HEPA filter that circulates filtered air in the sterilization chamber during the drying phase.

The iMax 9.5 DS Sterilizer is not an AI/ML device, therefore, the requested information elements such as sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details are not applicable as these pertain to performance studies for AI/ML devices.

However, based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iMax 9.5 DS Sterilizer are based on its ability to effectively sterilize heat and moisture-resistant medical and dental instruments and cloth packs according to predefined cycles. The "reported device performance" is essentially the successful demonstration of sterilization efficacy for these cycles.

*Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)
**Dental handpieces can be processed in the Wrapped instruments cycle only

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

Not applicable for this type of device. The "test set" in this context refers to items subjected to sterilization. The document mentions "clinically contaminated dental handpieces" but does not specify locations or if these were specifically from different countries. The general nature of the testing implies a retrospective use of samples for verification, but this is not explicitly stated.

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

Not applicable for this type of device. Sterilization efficacy is determined through biological indicators and laboratory methods, not expert consensus on image interpretation or similar.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Sterilization testing is objective, based on growth or no growth of microbial indicators.

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

Not applicable. The iMax 9.5 DS Sterilizer is a medical device, not an AI system.

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

Not applicable. The iMax 9.5 DS Sterilizer is a standalone medical device, but not an algorithm. Its performance is evaluated on its own ability to sterilize.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is sterility, typically confirmed through biological indicator (BI) testing. This involves challenging the sterilizer with highly resistant bacterial spores. A successful sterilization cycle renders the biological indicators sterile (i.e., no microbial growth after incubation), indicating effective killing of microorganisms. The document explicitly states "Biological testing was conducted to verify the sterilization efficacy of the preprogrammed process parameters."

8. The Sample Size for the Training Set

Not applicable for this type of device. This device does not use a "training set" in the AI/ML sense.

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

Not applicable for this type of device.

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