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The ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calcul in the kidney, ureter and bladder.

The ShockPulse-SE Lithotripsy System (CYBERWAND II) is the next generation of the CyberWand System. The ShockPulse-SE is an electromechanical device, whose intended purpose is to fragment and aspirate calculi. The hand piece consists of an ultrasonic transducer containing piezoelectric elements which are driven by a generator operating at approximately 21,000 Hz. The transducer is lightweight and incorporates two contact switches that activate Standard Power and High Power generator output. Activation will either require continuous pushing of the button or a double click to latch activation on; a single click of either button would then turn activation off. There are markings near the buttons to indicate function. Suction control is integrated into the transducer housing. With a thumb wheel that can rotate approximately 20 degrees, the flow can be varied from "full" on to "off." There are markings on the transducer to indicate which direction increases and decreases suction flow through the transducer lumen. There are families of probes that function similar to the probes of the current CyberWand System (K120303) by transmitting stress-waves from the transducer to the calculi to break up kidney-stones. Hollow probes permit simultaneous suction. The direct patient-contact material is stainless steel, which is the same material used in the predicate system.

The provided document is a 510(k) Summary for the ShockPulse-SE Lithotripsy System (CYBERWAND II). It details the device's technical specifications, indications for use, and a comparison to its predicate device, the CyberWand Dual Action Ultrasonic Lithotripsy System (K120303). The document primarily focuses on demonstrating substantial equivalence through performance data, safety considerations, and compliance with various standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several performance tests and validations to demonstrate the ShockPulse-SE Lithotripsy System (CYBERWAND II)'s safety and effectiveness and its substantial equivalence to the predicate device (CyberWand Dual Action Ultrasonic Lithotripsy System, K120303).

Summary of Studies and Information:

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

• CyberWand II Performance Analysis for Stone Breakage:
  • No specific sample size (number of stones, trials) is mentioned for the quantitative stone drilling and mass removal tests. The comparison states "at least 10% faster" and "at least 20% faster," implying a statistically significant difference was observed, but the underlying data points are not provided.
  • Data Provenance: Not specified, but generally in vitro (bench-top) or ex vivo (simulated use) given the nature of the tests (drilling into stones, mass removal).
• Retropulsion Study:
  • No specific sample size is mentioned. It compares the CyberWand II 1.65 probe to a "competitively marketed lithotripter" (LithoClast pneumatic).
  • Data Provenance: Implied in vitro or bench-top measurement, as it quantifies "impact force."
• Tissue Perforation Testing (Dr. Evans' Pig Kidney Test):
  • No specific sample size (number of kidneys or trials) is explicitly stated for the "Pig Kidney Test." It mentions "The CyberWand consistently induced less kidney tissue damage..." The ShockPulse SE system was "tested in simulated use conditions by several physicians in the porcine model."
  • Data Provenance: Ex vivo (freshly harvested porcine kidney) for the initial comparison with the predicate device. The subsequent test for ShockPulse SE was ex vivo in a porcine model.
• Life Cycle Analyses (Transducer, Torque Wrench, Generator, Footswitch):
  • Sample size: "50 simulated use cycles" for transducer and torque wrench. No specific number of units tested is provided for generator (7 years) or footswitch (durability).
  • Data Provenance: Bench-top, simulated use testing.
• Probe Reliability and Reusability Analysis:
  • Sample size: Refers to "functional after a single simulated use" for "5x typical use time," but the number of actual probes tested is not stated.
  • Data Provenance: Bench-top, simulated use testing.
• IEC 61847 Evaluation:
  • No specific sample size (number of probes or trials) for output characteristics or probe tip displacement.
  • Data Provenance: Bench-top measurements.
• Usability Verification and Validation:
  • Sample size: Not specified for stone fragmentation (simulated calculi), IFU usability, or customer needs. "Several physicians" were involved in the porcine model for tissue perforation, which might feed into "customer needs" indirectly.
  • Data Provenance: Bench-top for stone fragmentation; likely qualitative assessment for IFU and customer needs validation, possibly involving real users/physicians.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Tissue Perforation Testing: "Dr. Evans' Pig Kidney Test" and "several physicians" were involved in the porcine model for the ShockPulse SE.
  • Qualifications: "Dr. Evans" implies a qualified expert, and "physicians" indicates medical professionals. Specific specializations (e.g., urologists) and years of experience are not provided.
• For other performance tests like stone breakage, retropulsion, life cycle, EMC, electrical safety, usability, the "ground truth" is typically objective measurement against engineering specifications and validated test methods rather than expert consensus on a subjective finding.

4. Adjudication Method for the Test Set:

• Given that most tests are objective engineering or bench-top measurements (e.g., drill rate, mass removal, impact force, displacement, temperature, electrical safety, noise levels, torque, cycle counts), adjudication methods like 2+1 or 3+1 (common for subjective image interpretation) are not applicable.
• For the "Dr. Evans' Pig Kidney Test," a "visual assessment methodology" was used to compare tissue damage. The document doesn't specify if multiple observers were used or an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a "multi-reader multi-case (MRMC) comparative effectiveness study" focusing on human readers improving with AI vs. without AI assistance was not conducted. This is an electrohydraulic lithotripter for physical stone fragmentation, not an AI-assisted diagnostic or image interpretation device. The studies focus on device performance, safety, and functionality.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

• This question is not applicable as the device is a medical instrument (lithotripter), not an algorithm or AI software for diagnosis or image analysis. The device's "standalone" performance is evaluated through the bench-top and simulated use tests described (e.g., stone breakage, life cycle, safety, EMC).

7. Type of Ground Truth Used:

• Objective Measurements: For most tests (stone breakage, retropulsion, displacement, life cycle, noise, temperature, torque, electrical safety, EMC), the ground truth is established by objective, quantitative measurements against predefined engineering specifications, national/international standards (e.g., IEC 60601-1, CISPR 11), and internal performance targets derived from the predicate device.
• Comparisons to Predicate/Reference Devices: Performance (e.g., stone breakage, displacement, tissue damage, noise) is often compared directly to the predicate device (CyberWand I) or other legally marketed devices (LithoClast, Med-Sonics Corp. UreTron Multi Probe Lithotripter K111058), which serve as a benchmark for substantial equivalence.
• Expert Visual Assessment: For tissue perforation (Dr. Evans' Pig Kidney Test), ground truth was based on a "visual assessment methodology" of kidney tissue damage.
• Compliance with Standards: For regulatory aspects (electrical safety, EMC, risk management, software validation, sterilization validation), ground truth is compliance with specified regulatory standards and guidance documents.

8. Sample Size for the Training Set:

• This question is not applicable. The ShockPulse-SE Lithotripsy System is a mechanical/electronic medical device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The device's design is based on engineering principles and iterative development, not data-driven machine learning.

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

• This question is not applicable as there is no "training set" for this type of device. The design and performance validation rely on engineering specifications, physical testing, and comparison with predicate devices and established standards.

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