(23 days)
The intended use of the Tripter-X1 Duet Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.
The provided document is a 510(k) premarket notification for a medical device called the "Tripter X-1 Compact Duet with Sonographic Localization Option." This document relates to a device for Extracorporeal Shock Wave Lithotripsy (ESWL), which is a non-invasive procedure used to break up kidney stones.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "No clinical tests were performed." Therefore, there are no specific acceptance criteria or reported device performance metrics in this document. The device is cleared via a "special 510(k)" because it is considered a minor modification that does not change the fundamental technology or reduce safety and effectiveness compared to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical tests or test sets were used for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical tests or test sets were used, so no ground truth establishment by experts was performed.
4. Adjudication Method for the Test Set
Not applicable. No clinical tests or test sets were used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is not an AI-based diagnostic tool, and no MRMC studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-only device.
7. The Type of Ground Truth Used
Not applicable. No clinical tests were performed.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (lithotripter), not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.”)