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The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant" Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications.

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This document is a 510(k) clearance letter from the FDA for the Kodak Pro-Medical Digital Camera System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications related to the device's imaging quality or diagnostic accuracy.

The letter focuses on the regulatory clearance for marketing the device and its intended uses, which are:
"The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant" Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications."

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a technical performance study, or a more detailed section of the 510(k) submission that discusses the performance evaluation of the device.

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