(86 days)
The Storz MODULITH® Lithotripter SLX-F2 F180 is intended for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
The Storz MODULITH® Lithotripter SLX-F2 F180 is an Extracorporeal Shock Wave Lithotripter Device. It generates shock waves that are focused onto a kidney or ureteral stone so that the stone fragments can be passed with the patient's urine.
This document is a 510(k) summary for the Storz MODULITH® Lithotripter SLX-F2 F180. The content primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of efficacy. Therefore, I cannot extract information regarding study design, sample sizes, ground truth establishment, or multi-reader studies as these are not present in the provided text.
Based on the provided information, the device's performance acceptance criteria are implicitly related to its technological characteristics and intended use being similar to legally marketed predicate devices, rather than explicit quantitative metrics of fragmentation success rate for urinary calculi.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Storz MODULITH® SLX-F2 F180) |
|---|---|
| Shock wave generator: Electromagnetic | Shock wave generator: Electromagnetic |
| Treatment depth: Comparable to predicates (165 mm, 145-175 mm) | Treatment depth: 180 mm |
| Focal size: Comparable to predicates (e.g., F1: 2 x 20 mm, F2: 4.8 x 36 mm for SLX-F2; 11 x 175 mm for EM1000) | Focal size: F1: 2 x 24 mm, F2: 4.7 x 39 mm |
| Peak-positive pressure: Min/Max (MPa) comparable to predicates (e.g., F1: 18 - 107, F2: 16 - 44 for SLX-F2; 9.8 - 41.6 for EM1000) | Peak-positive pressure: F1: 18 - 107 MPa, F2: 15 - 36 MPa |
| Focal energy: Min/Max (MPa) comparable to predicates (e.g., F1: 2.2 - 2.5, F2: 4.3 - 5.5 for SLX-F2) | Focal energy: F1: 1.9 - 2.1 MPa, F2: 3.8 - 4.0 MPa |
| Number of Energy Levels: Comparable to predicates (e.g., 26 for SLX-F2) | Number of Energy Levels: 26 |
| Intended Use: Noninvasive fragmentation of urinary calculi in the kidney and upper ureter. | Intended Use: Noninvasive fragmentation of urinary calculi in the kidney and upper ureter. |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The submission is based on demonstrating substantial equivalence through comparison of technical specifications, not results from a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided. No clinical test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. No clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable/provided. This is a lithotripter, a medical device for breaking stones, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/provided. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable/provided. No clinical trial data is presented for this 510(k) summary, as it relies on substantial equivalence.
8. The sample size for the training set:
- This information is not applicable/provided. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- This information is not applicable/provided. As above, this is not an AI/machine learning device.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria, in the context of this 510(k) submission, is a comparison of technological characteristics and intended use against legally marketed predicate devices (Storz MODULITH® Lithotripter SLX-F2 and Medispec Econolith EM1000). The submission argues that "The minor differences between the Storz MODULITH® Lithotripter SLX-F2 and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This demonstrates "substantial equivalence" as the primary "acceptance criterion" for regulatory approval in this context.
§ 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.”)