(30 days)
The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.
The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal.
Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.
This is an FDA 510(k) summary for a medical device (Swiss LithoClast® Trilogy), not an AI/algorithm-driven device. Therefore, much of the requested information (such as AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
However, I can extract the relevant acceptance criteria and study information related to the device accessory.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No adverse impact on the handpiece sterile barrier system (pouch or wrap) during the steam sterilization process due to the use of the new Steri Holder accessory. | "Performance testing was conducted to verify that use of the Steri Holder during steam sterilization has no adverse impact on the handpiece sterile barrier system (pouch or wrap) during the steam sterilization process." (Implicitly, the device met this criterion by passing the testing). |
Study Details (as applicable to this non-AI device modification):
- Sample size used for the test set and the data provenance: Not specified in the document. The testing involved evaluating the sterile barrier system of the handpiece when sterilized with the Steri Holder. The document does not provide details on the number of handpieces or sterilization cycles tested, nor the provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device modification, ground truth would typically be established through standardized sterilization validation protocols and integrity testing, not "experts" in the context of diagnostic interpretation.
- Adjudication method for the test set: Not applicable in the context of expert consensus. Performance testing results are typically evaluated against pre-defined engineering and sterility validation standards.
- 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 document pertains to a medical device (lithotripter accessory), not an AI diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used: For this specific modification, the "ground truth" would be established by the validated integrity of the sterile barrier system after sterilization, assessed through standard sterility and packaging integrity tests (e.g., visual inspection, dye penetration, microbial ingress tests). The document states the testing was to verify "no adverse impact on the handpiece sterile barrier system."
- The sample size for the training set: Not applicable. There is no training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable. There is no training set for an AI algorithm.
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”