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Measurement of Dpd is intended for use as an aid in monitoring bone resorption changes in postmenopausal women receiving hormonal or bisphosphonate antiresorptive therapies and in individuals diagnosed with osteoporosis.

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The provided document is an FDA 510(k) clearance letter for the Pyrilinks®-D Assay Kit. 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 involvement as requested in the prompt.

Therefore, I cannot provide the requested information from this document. The letter is administrative in nature, confirming regulatory clearance, but it does not delve into the technical details of the performance study that would have been submitted to the FDA.

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Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Measurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with osteoporosis.

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The provided text is a 510(k) clearance letter from the FDA for the Pyrilinks®-D Assay, a urinary assay for deoxypyridinoline (Dpd) crosslinks. This document does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics in the format requested. It primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.

Therefore, I cannot extract the information required to populate the table and answer the study-related questions from this document. The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976," implying that its performance was assessed against predicate devices, but the specifics of that assessment are not detailed here.

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