(64 days)
The intended use of the Tripter-X1 Compact Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Compact 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) summary for the Tripter X-1 Compact Extracorporeal Shock Wave Lithotripter with a Sonographic Localization Option. It explicitly states that no clinical tests were performed (Section 7, "Clinical Tests").
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from clinical or standalone studies are mentioned.
- Sample size used for the test set and the data provenance: No test set data is mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
- Adjudication method for the test set: No adjudication method is mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: No MRMC study was performed.
- Standalone (algorithm only) performance: This device is a medical device (lithotripter), not an AI algorithm, so standalone performance in that context is not applicable. Even if it were, no performance studies were conducted.
- Type of ground truth used: Not applicable as no studies were performed.
- Sample size for the training set: Not applicable as no AI/algorithm training is mentioned for this device.
- How the ground truth for the training set was established: Not applicable as no AI/algorithm training is mentioned.
The submission claims that "The Compact with the Sonographic Localization Option meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Tripter X-1 Compact." This implies that its acceptance criteria were met by demonstrating substantial equivalence to predicate devices without the need for new clinical performance 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.”)