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Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation.

Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.

Image Processing System (Dextroscope™ MK10, Dextrobeam™ MK3 and MK4, RadioDexter™ 1.0)

The provided document is a 510(k) premarket notification letter from the FDA for an "Image Processing System (Dextroscope™ MK10, Dextrobeam™ MK3 and MK4, RadioDexter™ 1.0)". This letter confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets.

The letter is primarily a regulatory communication stating that the device can be legally marketed. It describes the device's intended use as "display and visualization of 3D medical image data derived from tomographic radiology images, excluding mammography images" for use by "qualified and trained medical professionals."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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