(347 days)
The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.
The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder. The system is an electromechanical device and consists of a generator, hand piece and probes. The hand piece is an ultrasonic transducer containing piezo-electric ceramic elements. The generator drives the hand piece at 21000 +/- 1000 Hz to get mechanical vibration through the probes to urinary tract calculi.
The provided text describes the UreTron Multi Probe Lithotripter, but it does not contain the detailed information necessary to complete the requested table and study questions. The document focuses on demonstrating substantial equivalence to predicate devices through performance data, but it does not specify acceptance criteria in quantitative terms or provide the specifics of the studies in the way requested.
Here's a breakdown of what can be extracted and what information is missing:
Information present in the document:
- Intended Use: Fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
- Performance Data: Verification and Validation tests were conducted to demonstrate functionality, sterility, and biocompatibility. Substantial equivalence was demonstrated by "stone model fragmentation testing, probe life testing and tissue perforation testing." The test data "proves UreTron's efficacy with stone model penetration rates as compared to the predicate devices."
- Product Name: UreTron™ Multi Probe Lithotripter
- Manufacturer: Med-Sonics, Corp.
Information NOT present in the document (and thus cannot be provided in the requested format):
- A table of specific, quantitative acceptance criteria.
- Reported device performance values against those specific criteria.
- Sample sizes used for any test sets mentioned (e.g., stone model fragmentation, probe life, tissue perforation).
- Data provenance (country of origin, retrospective/prospective for any test data).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for any test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human reader improvement with AI assistance (as this is an electromechanical device, not an AI/imaging device).
- Whether a standalone (algorithm only) performance study was done (again, not applicable for this type of device in the AI context).
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data) with specific details. The document mentions "stone model fragmentation", which implies synthetic ground truth.
- Sample size for the training set (not applicable as this is not an AI/ML device that requires a training set).
- How ground truth for the training set was established (not applicable).
Based on the provided text, here's what can be answered, with clear indications of missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Missing: Specific quantitative criteria are not provided. | Missing: Specific quantitative performance values are not reported. |
| (e.g., Stone fragmentation rate of X%; Probe life of Y hours; Tissue perforation depth |
§ 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.”