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

The Compact 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) summary for the Tripter X-1 Compact Extracorporeal Shock Wave Lithotripter with a Sonographic Localization Option. It explicitly states that no clinical tests were performed (Section 7, "Clinical Tests").

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from clinical or standalone studies are mentioned.
2. Sample size used for the test set and the data provenance: No test set data is mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
4. Adjudication method for the test set: No adjudication method is mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: No MRMC study was performed.
6. Standalone (algorithm only) performance: This device is a medical device (lithotripter), not an AI algorithm, so standalone performance in that context is not applicable. Even if it were, no performance studies were conducted.
7. Type of ground truth used: Not applicable as no studies were performed.
8. Sample size for the training set: Not applicable as no AI/algorithm training is mentioned for this device.
9. How the ground truth for the training set was established: Not applicable as no AI/algorithm training is mentioned.

The submission claims that "The Compact with the Sonographic Localization Option meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Tripter X-1 Compact." This implies that its acceptance criteria were met by demonstrating substantial equivalence to predicate devices without the need for new clinical performance studies.

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