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The intended uses of the MEDX InteCam™ Interface accessory together with the NuQuest™ Nuclear Medicine Computer are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals.

The NuQuest™ Nuclear Medicine Computer together with the MEDX InteCam™ Interface is used to acquire data from nuclear medicine gamma cameras. The data consists of a representation of the x coordinate and y coordinate of the position and optionally a signal representing the energy of a gamma ray emitted from the decay of radioisotopes injected into a patient. The position of the decay is calculated (a ray from the event to the detector) by the gamma camera. The positions of a large number of decay events are used to form an image of the location of the radioactive material. This image acquired can be displayed on a computer monitor or transferred to photographic film for review. The collection of data at multiple detector positions allows three dimensional information to be obtained by tomographic means. The computer is then used to reconstruct slices, or two dimensional views, of the data viewed from any angle or orientation. The computer can also be used to obtain quantitative information such as the number of counts in a particular area of the image, or the rate of change of counts in an area of the image with respect to time.

The provided K993893 document (510(k) summary) does not contain the type of detailed study information required to fill out the requested table regarding acceptance criteria and device performance.

Specifically, the document states: "The characteristics of the MEDX InteCam™ Interface when used with the NuQuest™ Nuclear Medicine Computer compare substantially with the predicate device, in both materials used, technology applied, and functional methodology. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate device."

This indicates that the submission relies on demonstrating substantial equivalence to a predicate device (G.E. Starcam 4000, K904174), rather than providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies. The FDA's decision letter confirms that they reviewed the 510(k) notification of intent to market and found the device "substantially equivalent."

Therefore, I cannot provide the requested table and study details from the given text. The document focuses on device description, intended use, and technological characteristics, asserting substantial equivalence but not presenting specific study results or performance metrics against defined acceptance criteria.

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