Search Results

The Storz Modulith® Lithotripter Models SLK is manufactured by Storz Indication: Medical AG are indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.
Storz Modulith® Lithotripter Model SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

The lithotripter models described in this submission are intended for use by qualified surgeons during a variety of lithotripsy surgical procedures.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Storz Modulith® Lithotripter Model SLK, a device indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.

The information provided confirms:

• Device Identification: Storz Modulith® Lithotripter Model SLK.
• Indication for Use: Therapeutic use in the treatment of ureteric calculi in lithotripsy procedures, and noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
• Regulatory Status: Substantial equivalence to legally marketed predicate devices, classifying it as a Class II device.

However, the document does not include details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document primarily focuses on the administrative and regulatory approval for marketing the device based on substantial equivalence, rather than providing details of specific performance studies against defined acceptance criteria.

Ask a specific question about this device