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The ULS0142 accessory is indicated for ultrasound localization of a target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

The ULS0142 accessory is an adjunct ultrasound localization system for use prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

The provided text is a 510(k) summary for the HMT Ultrasound Localization System ULS 0142. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot populate the requested table or answer the specific questions related to the study that proves the device meets acceptance criteria based on the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to an existing device rather than presenting detailed performance study results against predefined acceptance criteria.

Key takeaway: The provided document does not contain the information needed to answer your request about acceptance criteria and detailed study results.

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