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Oasis 4.0 is an automated Medical Report Writer intended to be used with the Sahara Bone Sonometer to help communicate the results of the test in a uniform, accurate, and consistent manner. The results are expressed as QUI (Quantitative Ultrasound Index), estimated bone mineral density (BMD), T-score, and Z-score. The estimated BMD is calculated from the QUI. The results are also translated into one of the diagnostic categories - Normal, Osteopenia, or Osteoporosis - based upon the WHO criteria and the normative reference data base. There is standardized language for the estimated risk of fracture and for the therapeutic options which the attending physician may recommend.

Oasis 4.0 Automated Medical Report Writer

The provided text is a 510(k) summary for the "Oasis 4.0 Automated Medical Report Writer." This document is a clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. It defines the device's intended use but does not contain details about specific acceptance criteria, performance studies, or the methodologies used to establish ground truth or gather data.

Therefore, I cannot provide the requested information based on the given input. The 510(k) clearance letter typically focuses on regulatory equivalence rather than a detailed scientific study report with performance metrics.

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