(28 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 has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.
The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a 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.
The provided text is a 510(k) summary for a medical device called the "Swiss LithoClast® Trilogy". This document primarily focuses on demonstrating substantial equivalence to a predicate device for the purpose of adding new sterilization methods for a reusable handpiece. It does not contain information about a study proving the device meets acceptance criteria related to its clinical performance (e.g., fragmentation and removal of urinary tract calculi) or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, many of the requested sections regarding clinical performance, expert ground truth, sample sizes for test and training sets, and human reader improvement with AI assistance cannot be extracted from this document.
However, I can extract information related to the sterilization validation, which is the core of this particular 510(k) submission.
Here's a summary of what can be extracted:
1. Table of acceptance criteria and the reported device performance (for sterilization):
| Acceptance Criterion (for sterilization) | Reported Device Performance (for sterilization) |
|---|---|
| Achievement of Sterility Assurance Level (SAL) 10⁻⁶ | Demonstrated SAL 10⁻⁶ for each sterilizer |
2. Sample sized used for the test set and the data provenance: Not applicable. This document describes a sterilization validation, not clinical performance testing on a test set of patient data. The "test set" in this context refers to the items (e.g., handpieces) subjected to the sterilization process. The provenance is internal validation testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a sterilization validation, not a study requiring expert clinical interpretation.
4. Adjudication method for the test set: Not applicable.
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: No, an MRMC study was not done, as this document concerns a medical device for stone fragmentation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI algorithm.
7. The type of ground truth used:
- For sterilization: The ground truth for sterilization validation is the scientific standard of achieving a Sterility Assurance Level (SAL) of 10⁻⁶, based on established microbiological testing methods.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
Additional information related to the sterilization validation from the document:
- Sterilization Standard: The validation was conducted in accordance with ISO 14937:2009 "Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices."
- Sterilization Parameters: The recommended sterilization parameters for each H₂O₂ sterilizer were used.
- Sterilizers Validated:
- STERIS V-PRO 1
- STERIS V-PRO 60
- STERIS V-PRO maX
- STERRAD 100S Short
- STERRAD NX Standard
- Device Component Subject to Validation: The reusable Trilogy handpiece.
In summary, this document provides evidence for the sterilization efficacy of the reusable handpiece, but not for the clinical performance of the device in fragmenting and removing urinary tract calculi.
§ 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.”