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The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.

The TwinTrode® ELC 134 Electrode is a multiple patient use electrode for electrohydraulic extracorporeal shock wave lithotripter. It is substantially equivalent to the NewTrode® ELC 124 Both electrodes are components of the HealthTronics LithoTron Electrode (predicate device). Lithotripsy System. The TwinTrode and NewTrode devices are very similar and are utilized as part of the LithoTron The TwinTrode differs from the NewTrode in that the longevity of the system identically. TwinTrode is up to 2.5 times greater than the longevity of the NewTrode.

This submission pertains to the TwinTrode® ELC 134 Electrode, a device used in lithotripsy procedures.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Longevity (total usable shocks) to be substantially equivalent or improved over predicate.	Longevity of TwinTrode® is "up to 2.5 times greater than the longevity of the NewTrode®."

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified. The document states "Performance testing verifying this increase in total useable shocks has been provided in the 510(k)," but does not detail the sample size (e.g., number of electrodes tested).
   • Data Provenance: Not explicitly stated, but implies laboratory or bench testing ("Performance testing"). There is no mention of human subject data, and it's unlikely given the nature of the device and the statement "Clinical data were not required to demonstrate substantial equivalence."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Not applicable. This device's performance evaluation focuses on physical longevity rather than diagnostic accuracy requiring expert image interpretation or clinical assessment.

4. Adjudication Method for the Test Set:

   • Not applicable. The "ground truth" for this device's performance is measured empirically (total usable shocks), not via expert human judgment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This type of study is typically for evaluating diagnostic imaging or AI algorithms where human readers are involved. The TwinTrode® is a component of a lithotripsy system, and its evaluation did not involve human readers interpreting "cases."

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

   • The study was standalone in the sense that it likely involved direct testing of the device's physical properties (longevity) without human intervention in the performance measurement itself. However, it's not an "algorithm only" study as it's a physical medical device, not a software algorithm. The performance testing was of the device itself.

7. The Type of Ground Truth Used:

   • Empirical Performance Data: The ground truth for the TwinTrode® seems to be based on direct measurement of the device's durability or "longevity" in terms of "total useable shocks." This is a quantifiable physical characteristic.

8. The Sample Size for the Training Set:

   • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The performance data is from the device itself, not from an algorithm trained on a dataset.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set mentioned or implied.

Summary of the Study:

The study conducted for the TwinTrode® ELC 134 Electrode was a performance testing focused on demonstrating its longevity (total usable shocks) compared to its predicate device, the NewTrode® ELC 124. The only explicit performance criterion mentioned is that the TwinTrode®'s longevity is "up to 2.5 times greater" than the predicate.

The 510(k) submission explicitly states: "Clinical data were not required to demonstrate substantial equivalence." This indicates that the evaluation was primarily based on non-clinical performance data, likely bench or laboratory testing, rather than studies involving human patients or complex diagnostic assessments. The document does not provide details on the specific methodology, sample sizes of devices tested, or the exact test conditions, beyond stating that "Performance testing verifying this increase in total useable shocks has been provided in the 510(k)."

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