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The intended use of the Tripter-X1 Duet Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.

The provided document is a 510(k) premarket notification for a medical device called the "Tripter X-1 Compact Duet with Sonographic Localization Option." This document relates to a device for Extracorporeal Shock Wave Lithotripsy (ESWL), which is a non-invasive procedure used to break up kidney stones.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "No clinical tests were performed." Therefore, there are no specific acceptance criteria or reported device performance metrics in this document. The device is cleared via a "special 510(k)" because it is considered a minor modification that does not change the fundamental technology or reduce safety and effectiveness compared to a predicate device.

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

Not applicable. No clinical tests or test sets were used for this submission.

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

Not applicable. No clinical tests or test sets were used, so no ground truth establishment by experts was performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical tests or test sets were used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-based diagnostic tool, and no MRMC studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

Not applicable. No clinical tests were performed.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (lithotripter), not a machine learning algorithm requiring a training set.

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

Not applicable. No training set was used.

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