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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. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

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

The acquisition system consists of a single small field-of-view detector mounted on an articulating arm to allow precise positioning of the detector over the patient's heart. In addition, a vertical lift adjusts the detector height position to track changes in the incline of the treadmill to ensure camera remains positioned directly over the patient's heart during acquisition.

The provided text is a 510(k) summary for the OnePass Nuclear Medicine Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, reported device performance metrics, sample sizes, ground truth establishment methods, or any details about human reader studies (MRMC or standalone).

The document primarily focuses on:

• Device identification: Name, classification, contact information.
• Device description: How it acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images using a single small field-of-view detector.
• Intended Use: Diagnostic imaging to depict anatomical distribution of radioisotopes, specifically optimized for cardiac first pass data to assess left and right ventricular function.
• Predicate Device: Scinticor SIM-400 System (K931193).
• Claim of Substantial Equivalence: The OnePass is comparable and substantially equivalent to the SIM-400 for FPRNA studies, with the primary difference being that OnePass is optimized only for FPRNA, while SIM-400 can perform other study types.
• Conclusion: No new safety risks, performs as well as the SIM-400 for FPRNA.
• FDA Clearance Letter: A formal letter from the FDA granting clearance based on the substantial equivalence claim.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance metrics as they are not present in the provided text. The document is a regulatory submission, not a detailed scientific study report.

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