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 ofLoad andLoad weight	SterilizationTemperature	SterilizationTime	Drying Time(recommended)
Pouches HeavyLoad	Instrumentsand DentalHandpiecesup to 18 lbs	270° F (132°C)	4 minutes	30 minutes
PouchesMedium Load	Instrumentsand DentalHandpiecesup to 3 lbs	270° F (132°C)	4 minutes	25 minutes
PouchesLarge Load	Instrumentsand DentalHandpiecesup to 6 lbs	270° F (132°C)	4 minutes	30 minutes
Pouches&WrappedCassettes	Instrumentsand DentalHandpiecesup to 11 lbs	270° F (132°C)	4 minutes	35 minutes
WrappedCassettes	Instrumentsand DentalHandpiecesup to 14 lbs	270° F (132°C)	4 minutes	40 minutes
LowTemperature	Textiles, Up4.4 lbs, orInstrumentsand DentalHandpiecesRequiringLowTemperatureup to 5 lbs.	250° F (121°C)	30 minutes	30 minutes

Device Description

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.

AI/ML Overview

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:

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)

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.
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).
Adjudication method: Not applicable/Not provided in the document.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical sterilizer device.
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.
The sample size for the training set: Not applicable/Not provided in the document.
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.

Summary

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May 30, 2018

W&H Sterilization s.r.l. Marco Parolini QA and RA Manager Via Bolgara, 2 Brusaporto, Italy

Re: K172825

Trade/Device Name: MN-111 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: April 27, 2018 Received: April 30, 2018

Dear Marco Parolini:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172825

Device Name

W&H Steam Sterilizer MN-111

Indications for Use (Describe)

Program	Type ofLoad andLoad weight	SterilizationTemperature	SterilizationTime	Drying Time(recommended)
Pouches HeavyLoad	Instrumentsand DentalHandpiecesup to 18 lbs	270° F (132°C)	4 minutes	30 minutes
PouchesMedium Load	Instrumentsand DentalHandpiecesup to 3 lbs	270° F (132°C)	4 minutes	25 minutes
PouchesLarge Load	Instrumentsand DentalHandpiecesup to 6 lbs	270° F (132°C)	4 minutes	30 minutes
Pouches&WrappedCassettes	Instrumentsand DentalHandpiecesup to 11 lbs	270° F (132°C)	4 minutes	35 minutes
WrappedCassettes	Instrumentsand DentalHandpiecesup to 14 lbs	270° F (132°C)	4 minutes	40 minutes
LowTemperature	Textiles, Up4.4 lbs, orInstrumentsand DentalHandpiecesRequiringLowTemperatureup to 5 lbs.	250° F (121°C)	30 minutes	30 minutes

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Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).