(80 days)
The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.
The LITHOSPECTM is a direct contact intracorporeal lithotripter which fragments bladder, ureteral and renal calculi by utilizing direct endoscopic techniques. The electromechanical technique ensures the delivery of high impact mechanical fragmentation power to the stone while eliminating the possibility of thermal injury. Four reusable Probes, having diameters: 0.8 mm, 1.6 mm, and 2.0 mm, are provided with the system. The LITHOSPEC™ is operated using standard endoscopic equipment.
The provided text does not contain information about acceptance criteria and a study proving device performance in the context of typical AI/ML medical device evaluations (e.g., sensitivity, specificity, AUC, human reader studies).
Instead, this document is a 510(k) summary for a mechanical intracorporeal lithotripter (LITHOSPEC™), a physical medical device for crushing kidney stones. The "performance" described here refers to its mechanical capabilities and safety compliance, not AI algorithm performance.
Therefore, I cannot fulfill the request as the type of information requested (acceptance criteria and study design for AI/ML performance) is not present in the provided context for this particular device.
Here's why and what can be inferred:
- Type of Device: The LITHOSPEC™ is a physical surgical tool, an "Intracorporeal Lithotripter," not an AI/ML diagnostic or predictive algorithm.
- Performance Standards: The document states "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." Instead, it complies with general electrical safety and EMC (Electromagnetic Compatibility) standards like IEC 601.1.2, IEC 801.1-801.5, EN 55011, and EN 50081-1. This is typical for electromechanical devices.
- Substantial Equivalence: The primary "proof" of its safety and effectiveness for a 510(k) clearance is its "substantial equivalence" to predicate devices (EMS SWISS LITHOCLAST LITHOTRIPTER cleared under K951531 and K963285) in terms of intended use, technological characteristics, performance, and labeling. This means it is presumed to be as safe and effective as devices already on the market without needing extensive new clinical trials for performance metrics like sensitivity/specificity.
To directly answer your specific points based on the absence of this information in the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable/Not provided in the context of AI/ML performance. Performance mentioned relates to compliance with electrical safety and EMC standards.
- Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the AI/ML sense is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- 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 is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: Not applicable in the AI/ML diagnostic sense. The "ground truth" for this device would be its mechanical ability to fragment stones safely, likely evaluated through bench testing, animal studies, and/or clinical experience demonstrating equivalent function to predicate devices, rather than a diagnostic 'truth'.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.”