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The W&H Steam Sterilizer MN-111 is designed for pressurized steam sterilization of medical and pouched dental instruments, including dental handpiece, porous and hollow loads. Key program features, including sterilization time, temperature and recommended load type are listed in the following table:

| Program | Type of
Load and
Load weight | Sterilization
Temperature | Sterilization
Time | Drying Time
(recommended) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------|------------------------------|
| Pouches Heavy
Load | Instruments
and Dental
Handpieces
up to 18 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches
Medium Load | Instruments
and Dental
Handpieces
up to 3 lbs | 270° F (132°C) | 4 minutes | 25 minutes |
| Pouches
Large Load | Instruments
and Dental
Handpieces
up to 6 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches
&Wrapped
Cassettes | Instruments
and Dental
Handpieces
up to 11 lbs | 270° F (132°C) | 4 minutes | 35 minutes |
| Wrapped
Cassettes | Instruments
and Dental
Handpieces
up to 14 lbs | 270° F (132°C) | 4 minutes | 40 minutes |
| Low
Temperature | Textiles, Up
4.4 lbs, or
Instruments
and Dental
Handpieces
Requiring
Low
Temperature
up to 5 lbs. | 250° F (121°C) | 30 minutes | 30 minutes |

The W&H Steam Sterilizer MN-111 is designed for pressurized steam sterilization of medical and pouched dental instruments, including dental handpiece, porous and hollow loads.

The provided document is an FDA 510(k) clearance letter for a steam sterilizer, K172825 W&H Steam Sterilizer MN-111. It's a regulatory approval document and does not contain information about a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

The document discusses the device's "Indications for Use," which outlines the types of loads it can sterilize, along with sterilization temperature, time, and recommended drying time for various programs. These are fundamentally operating parameters and capabilities, not acceptance criteria for a diagnostic device or an AI performance study.

Therefore, most of the requested information (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC study, standalone performance, training set) is not present in this document.

For clarity, I will address what can be inferred from the document regarding "acceptance criteria" in a general sense for a sterilizer device.

General Interpretation of "Acceptance Criteria" for a Sterilizer in this Context:

While not explicitly stated as "acceptance criteria" in the AI/ML sense, for a sterilizer, the core "acceptance criteria" for its function would be its ability to achieve sterility for the specified loads under the given parameters. This is typically demonstrated through biological and physical indicator tests, and process validation studies, which are not detailed in this clearance letter but would have been part of the submission package to the FDA.

The table provided lists the operating parameters and intended uses for the sterilizer's different programs. If we were to interpret these as a form of acceptance criteria for a sterilizer's performance claim, then the "reported device performance" would be that it successfully sterilizes the described loads under these conditions. However, the document does not provide detailed study results that demonstrate this "performance."

Summary regarding the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied from Indications for Use Table): The device must be capable of sterilizing the specified "Type of Load and Load Weight" at the "Sterilization Temperature" and "Sterilization Time" listed for each "Program." The "Drying Time" is a recommended operational parameter.
   • Reported Device Performance: The document does not contain reported device performance data or study results. It only states the intended use and operational parameters. It implies that the device is capable of performing according to these parameters, which would have been substantiated by underlying validation studies not present in this public clearance letter.

   Program	Type of Load and Load weight	Sterilization Temperature	Sterilization Time	Drying Time (recommended)	Reported Performance
   Pouches Heavy Load	Instruments and Dental Handpieces up to 18 lbs	270° F (132°C)	4 minutes	30 minutes	(Not detailed in this document, but implied to meet these parameters for sterility)
   Pouches Medium Load	Instruments and Dental Handpieces up to 3 lbs	270° F (132°C)	4 minutes	25 minutes	(Not detailed in this document, but implied to meet these parameters for sterility)
   Pouches Large Load	Instruments and Dental Handpieces up to 6 lbs	270° F (132°C)	4 minutes	30 minutes	(Not detailed in this document, but implied to meet these parameters for sterility)
   Pouches & Wrapped Cassettes	Instruments and Dental Handpieces up to 11 lbs	270° F (132°C)	4 minutes	35 minutes	(Not detailed in this document, but implied to meet these parameters for sterility)
   Wrapped Cassettes	Instruments and Dental Handpieces up to 14 lbs	270° F (132°C)	4 minutes	40 minutes	(Not detailed in this document, but implied to meet these parameters for sterility)
   Low Temperature	Textiles, Up 4.4 lbs, or Instruments and Dental Handpieces Requiring Low Temperature up to 5 lbs.	250° F (121°C)	30 minutes	30 minutes	(Not detailed in this document, but implied to meet these parameters for sterility)

2. Sample sized used for the test set and the data provenance: Not applicable/Not provided in the document. This is not an AI/ML or diagnostic study. Sterilizer validation involves specific biological indicator test loads and physical challenges, rather than "test sets" of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided in the document. Ground truth for a sterilizer is typically established by biological indicator kill-data and physical parameters (temperature/pressure/time).

4. Adjudication method: Not applicable/Not provided in the document.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical sterilizer device.

7. The type of ground truth used: For a sterilizer, the ground truth is the successful inactivation of microorganisms (sterility) confirmed by biological indicators (e.g., spore strips) and adherence to physical parameters (temperature, pressure, time) validated through engineering and microbiological studies. These specific study details are not in this document.

8. The sample size for the training set: Not applicable/Not provided in the document.

9. How the ground truth for the training set was established: Not applicable/Not provided in the document.

In conclusion, this document is a regulatory clearance for a physical medical device (steam sterilizer) and does not provide information relevant to AI/ML device performance or diagnostic study criteria.

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