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The Delta™ 2000 Series Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The DELTA lithotripter utilizes well known spark gap technology. To generate a shock wave utilizing this method, an electrical discharge is created between two electrodes submerged in water. This sudden discharge of the enormous amount of energy lasts less than 1 microsecond. During this time an evaporation of water surrounding the gap between the electrodes occurs. The evaporation causes an instant expansion of vapor which produces a shock wave. In an extracorporeal lithotripter, the two wire electrodes are embedded in a plastic tube filled with insulating material. On one end of the tube the tips of the wire are bent towards each other with a small gap between them. A source of electrical energy is connected to each wire on the other end of this tubular structure. This electrode assembly is placed inside an ellipsoidal reflector in such a way that the gap between the two conductors coincides with the first focal point of the reflector. The reflector is filled with water and covered with a thin elastic membrane. After discharging the energy, reflected shock waves are transmitted to the second focal point through noncompressible medium, such as water in the reflector and in human tissue. The energy generated at the first focal point is recaptured at the second focal point of the ellipsoidal reflector with only minimal losses. When the second focal point is positioned on the treatment area such as the kidney stone inside the body, the repeated impact of the shock waves on the stone, at various energy levels, causes its disintegration.

This document describes a 510(k) premarket notification for the "Delta™ 2000" Series Lithotripter, seeking substantial equivalence to a predicate device. This is primarily a regulatory submission, not a study report that details specific acceptance criteria and performance data in the structured way requested. Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here is the information that can be extracted, along with explanations for what cannot be provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., stone fragmentation rate, success rate, energy delivery accuracy) nor independent "reported device performance" against such criteria. The basis of acceptance is substantial equivalence to a predicate device (EDAP Technomed Sonolith Praktis, K003529).

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

• Sample Size (Test Set): Not specified. The document states "clinical experience demonstrates that the device is equivalent," but it does not provide details about a specific clinical study with a defined test set sample size.
• Data Provenance: Not specified. It refers to "clinical experience" generally, without indicating country of origin, or whether it was retrospective or prospective.

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

• Not applicable. This is a medical device approval document based on substantial equivalence, not an AI/diagnostic algorithm study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

• Not applicable for the same reason as above.

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. This is not an AI-assisted diagnostic device, nor does the document describe an MRMC study.

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

• Not applicable. This is a medical device, not a standalone algorithm.

7. The Type of Ground Truth Used:

• The concept of "ground truth" as typically used in AI/diagnostic evaluation is not directly applicable here. The "truth" for this device's approval is its substantial equivalence to an already legally marketed predicate device, based on comparable characteristics, standards compliance, and overall safety and effectiveness ("clinical experience").

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.

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

• Not applicable for the same reason as above.

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