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The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The OnePass system's design is optimized for acquiring and processing cardiac first pass data. Firstpass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

The OnePass Nuclear Medicine Imaging System acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available for processing and analysis.

The device consists of a vertical support, a single small FOV detector mounted on an articulating arm, a 15 in. color LCD acquisition display, and an acquisition and processing computer workstation. The OnePass system's small field-of-view (FOV) detector and small system footprint are designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The provided text is a 510(k) premarket notification for a medical device and does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document states that the OnePass Nuclear Medicine Imaging System is a modification of a previously cleared device (K0233373) and that this modification provides a "slightly larger UFOV to aid the operator" and a "new software application to automatically archive system-specific data files." The submission asserts substantial equivalence based on comparable type, similar performance characteristics, same technological characteristics, identical key safety and effectiveness features, same basic design, and same intended use as the predicate device.

The FDA's letter (K051402) acknowledges the substantial equivalence to a legally marketed predicate device, allowing the device to proceed to market. However, it does not describe specific acceptance criteria or an analytical or clinical study with the details requested in your prompt.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth for this device from the provided text. This type of information is typically found in detailed performance and clinical validation studies, which are not included in this summary of safety and effectiveness.

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