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Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam.

The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following:

• Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs)

• Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)

Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam.

The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following:

• Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs)

• Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)

The provided text is related to an FDA 510(k) clearance for a steam sterilizer (Lexa MINI), not a device that involves AI/ML, human readers, or a test set with ground truth established by experts.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the given document. These are typical requirements for evaluating the performance of AI/ML-driven medical devices, which the Lexa MINI sterilizer is not.

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Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam. The Lexa MINI has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.

Key program features, including sterilization time, temperature and recommended load type are listed in the following:

• Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs); wrapped Porous/ Textile load (0.22 lbs)

• Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)

• Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)

Not Found

The provided text is a 510(k) summary for the Lexa MINI steam sterilizer, a Class II medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria, as one would typically find for an AI/ML-driven device.

The document focuses on the FDA's decision to clear the device for market, based on its substantial equivalence to predicate devices, and outlines regulatory requirements for the manufacturer. It specifies the intended use of the sterilizer, its operating parameters (sterilization time, temperature, drying time, and recommended load types), and its classification as an Over-The-Counter Use device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies from the provided text. This type of information is typically found in performance studies or clinical validation sections of a 510(k) submission, not in the FDA's clearance letter and indications for use.

Ask a specific question about this device