(149 days)
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.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)