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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.

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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.

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