Search Results

UreTron PF Series Probes are to be used with UreTron Multi Probe Lithotripsy System. UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Not Found

This FDA 510(k) summary does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study design. This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device, rather than a clinical trial report or a summary of performance data.

Here's what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance

• Missing. This document does not specify any quantitative acceptance criteria or report device performance data against such criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, not necessarily on meeting pre-defined performance metrics articulated in this letter.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing. No information on sample size, data provenance, or study type (retrospective/prospective) of any test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing. No information about experts or ground truth establishment is included.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing. No information regarding adjudication methods is provided.

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 / Missing. This device (UreTron PF Series Probes for lithotripsy) is an electrohydraulic lithotriptor probe, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant. The document does not indicate any AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Missing. As above, this is a medical device for treatment, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Missing. This document does not mention any ground truth associated with performance evaluation.

8. The sample size for the training set

• Not applicable / Missing. There is no indication of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable / Missing. This information is not relevant for this type of device and is not present in the document.

Summary of available information from the document:

• Device Name: UreTron PF Series Probes
• Intended Use: Used with UreTron Multi Probe Lithotripsy System for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
• Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
• Regulatory Class: Class II
• Product Code: FFK
• Regulation Name: Electrohydraulic Lithotriptor

To obtain the detailed performance data and study design information, one would typically need to refer to the full 510(k) submission, which is not publicly released in its entirety but may have a publicly accessible summary (510(k) Summary). This letter only confirms the clearance.

Ask a specific question about this device

The UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the UreTron MultiProbe Lithotripter System. It acknowledges the device's substantial equivalence to existing devices and outlines regulatory compliance requirements.

This document does not contain any information regarding:

• Acceptance criteria for device performance.
• Details of a study that proves the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used or details about a training set.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

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

Ask a specific question about this device