(182 days)
The Storz SLX-F2 Storm Touch® software allows remote control / display communication between Storz Communication Buss® (SCB) network computer and SLX-F2 System® via a graphic user interface with a touch panel LCD screen. The SLX-F2 Storm Touch® interface communication software permits additional remote control and adjustment of the third party device through Storm Touch®.
The new Storm Touch® software allows remote control / display / communication between the SCB system and SLX-F2 System via a graphic user interface with a touch panel LCD screen. The main function of the Storm Touch® graphical user interface is to support the doctor by displaying SLX-F2 control panel System including its x-ray parameters during lithotripsy treatment or surgery. This SCB Storm Touch® communication software does not add any new clinical function to the SLX-F2 and third party devices. Storm Touch® has the same graphic user interface principle as our original SCB graphic interface software. Storm Touch® is installed as an optional software in the SCB computer which is located in the OR suite. SLX -F2 connects to the SCB system by a specific Buss Connectors in the SCB computer with a designated cable. The SCB Storm Touch® interface communication software also permits additional remote control and adjustment of the third party device. All third party devices that are connected to the SCB Storm Touch may still be controlled by the original device overwriting the SCB control. In case the additional remote control is not required, control of the device still remains with the device itself. The SCB Storm Touch® software allows additional optional control / communication of the third party device with the SCB.
The provided text is a 510(k) summary for the Storz SLX-F2 Storm Touch® device. It focuses on the device's function as a remote control/display interface for an extracorporeal shock wave lithotripter (SLX-F2 System®) and its substantial equivalence to predicate devices, rather than a study demonstrating clinical performance or meeting specific acceptance criteria for a new medical function.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this document. The submission is primarily about demonstrating that the software does not add new clinical function and is substantially equivalent to existing devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This 510(k) summary does not define specific "acceptance criteria" for clinical performance or present a study with quantitative performance metrics for the Storm Touch® software itself. Its acceptance is based on demonstrating substantial equivalence to predicate devices because it does not introduce new clinical functions, but rather enhances user interface and remote control capabilities.
2. Sample size used for the test set and the data provenance
No test set for clinical performance is described. The device is a software interface, and the submission emphasizes that "This SCB Storm Touch® communication software does not add any new clinical function to the SLX-F2 and third party devices." Therefore, no patient data or specific clinical test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for a clinical test set is established or mentioned, as the device doesn't introduce new clinical functions requiring such validation.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication 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
Not applicable. This device is not an AI or imaging interpretation system, and no MRMC study or AI-assisted improvement is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is explicitly a "remote control / display / communication" interface to assist human operators (doctors) with an existing lithotripsy system. It is not an algorithm performing a standalone task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical performance data. The "ground truth" implicitly relied upon here is that the SLX-F2 System® (the lithotripter it controls) is already a legally marketed and established device, and the new software merely provides an alternative interface for its existing functions.
8. The sample size for the training set
Not applicable. The document describes a software interface, not a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or machine learning components.
§ 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.”)