(348 days)
The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.
The MODULITH® Lithotripter SLX-F2 is an Extracorporeal Shock Wave Lithotripter Device. It generates shock waves that are focused onto the urinary calculi so that the stone fragments can be passed with the patient's urine.
The provided text is a 510(k) summary for the KARL STORZ Endoscopy-America, Inc. Modulith SLX-F2, an Extracorporeal Shock Wave Lithotripter. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI, or multi-reader multi-case (MRMC) studies.
The provided text only discusses the following in relation to performance data:
- Non-Clinical Performance Data: "The MODULITH SLX-F2 follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 61849), Software Verification and Validation Testing (Guidance for the Content of Premarket Submissions for Software Contained in Medical Device Level of concern: Moderate). Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the MODULITH SLX-F2 has met all its design specification and is substantially equivalent to its predicate device."
- Clinical Performance Data: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. However, literature reviews on the effectiveness of the subject device or equivalent devices on pediatric population and an analysis of stone composition in patient between 1 to 18 years old to support the applicability of OUS data to US population was provided to establish substantial equivalence for use in pediatric populations."
In summary, the document does not provide the 9 specific pieces of information requested because it's a 510(k) summary for a physical medical device (lithotripter), not an AI/algorithm-driven device requiring performance metrics like sensitivity, specificity, or MRMC studies.
§ 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.”)