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The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Twinheads® TH-103 ESWL is a spark gap dual head shock wave lithotripter for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-103 delivers a pair of shock wayes, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing legally marketed C-arm fluoroscopy system via two orientations. Also included is an accurate motorized table with carbon fiber top.

The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device, a lithotripter, and its clearance process through a 510(k) submission.

Here's a breakdown of why the requested information is absent and what the document does say:

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

• Not applicable to this document. This document is for a physical medical device (Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter), not an AI/ML device. Acceptance criteria for such a device would typically involve mechanical specifications, safety features, energy delivery parameters, and clinical efficacy (e.g., stone-free rates, re-treatment rates), which are not explicitly detailed as acceptance criteria in this summary. The "reported device performance" would typically be derived from clinical studies or non-clinical tests, neither of which are extensively detailed or used to establish "acceptance criteria" in this 510k summary.

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

• Not applicable to this document. No test set in the context of AI/ML validation is mentioned.

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)

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

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

• Not applicable to this document. No adjudication method for an AI/ML test set is mentioned.

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 to this document. No MRMC study or AI assistance is mentioned.

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

• Not applicable to this document. The device is a physical lithotripter, not an algorithm.

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

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

8. The sample size for the training set

• Not applicable to this document. No training set for an AI/ML algorithm is mentioned.

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

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

What the document does state regarding acceptance criteria and studies:

The document explicitly states:

• "No clinical studies were performed."
• The premise for clearance is substantial equivalence to a predicate device (Twinheads® TH-101 ESWL, K030346).
• The Twinheads® TH-103 ESWL is described as a "modification" of the predicate device, having the "same fundamental scientific technology and intended use."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the FDA's "substantial equivalence" determination, based on the device having similar technological characteristics and intended use to a previously cleared device, without the need for new clinical data. The "proof" is the comparison to the predicate device and the claim that the modifications do not change the fundamental scientific technology.

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