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The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration.

The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration.

The provided text is a 510(k) summary for a medical device (sterilization tray) and does not contain information about the acceptance criteria or a study proving the device meets certain performance criteria in the context of AI/ML or diagnostic performance. Instead, it details regulatory information, device classification, and indications for use, primarily focusing on sterilization methods and the instruments the tray is designed to hold.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, ground truth, MRMC study, standalone performance, training set details) from the provided text as it is not relevant to the type of device or performance evaluation typically associated with those terms.

The document discusses "sterilization validation has been conducted in accordance with the requirements of AAMI TIR 12" and "Validation was conducted using an FDA cleared sterilization wrap with a maximum load of 8.1 lbs. (3.67 kg)", which are related to performance, but not in the context of an AI/ML clinical study.

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