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The indication for use for the K.M.I. Kolster Methods Inc. Stars2000 power cannula device is for situations requiring the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Stars2000 Power Cannula," a suction lipoplasty system. It does not contain information about acceptance criteria, study details, or device performance metrics.

The letter primarily focuses on:

• Notifying the applicant of an administrative change (new product code).
• Confirming the substantial equivalence determination made in 2001.
• Outlining the regulatory requirements for marketing the device.
• Stating the intended use of the device.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, or standalone performance) from the provided text. This type of information would typically be found in the 510(k) submission itself, not in the clearance letter.

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