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The CyberWand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

The CyberWand Dual Action Ultrasonic Lithotripsy System includes a Generator, Transducer (2), Footswitch, Power Cord, Wrench, and Cleaning Stylet. The disposable probe set is sold separately either sterile or non-sterile. The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements, which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CyberWand Dual Action Ultrasonic Lithotripsy System:

Summary of Device and Context:

The CyberWand Dual Action Ultrasonic Lithotripsy System is an electromechanical device designed for the fragmentation and aspiration of urinary tract calculi (kidney, ureter, and bladder stones). This submission is an Abbreviated 510(k), indicating a reliance on substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Reported Device Performance:

Based on the provided text, the acceptance criteria are primarily focused on safety, performance standards compliance, and equivalence to predicate devices, rather than specific clinical efficacy metrics like sensitivity or specificity.

Since this is an Abbreviated 510(k) submission for a device built on established technology with predicate devices, the "study that proves the device meets the acceptance criteria" primarily consists of:

• Engineering bench testing and verification studies: These confirm that the new device adheres to specific design specifications, performance parameters (like drill rate, vibration, temperature profiles), compatibility, and durability, replicating or exceeding previous results.
• Compliance with recognized national and international consensus standards: This is a key component of demonstrating safety and fundamental performance for such devices.
• Validation of manufacturing processes: Especially sterilization and software.

The document does not describe a clinical study comparing human readers with AI assistance, or any clinical performance metrics like sensitivity, specificity, or clinical outcomes (e.g., stone fragmentation rates in patients). This is typical for devices cleared via substantial equivalence where safety and basic performance are demonstrated through non-clinical means and equivalence to a device with a known safety and efficacy profile.

Here's a breakdown of the other requested information based on the provided text:

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a typical clinical test set for AI performance. The "test sets" here refer to batches of devices/components used for engineering verification (e.g., advanced transducers, probes) and sterility validation (e.g., biological indicators, inoculated devices, double wrapped probes). Specific numerical sample sizes for these tests are not provided in the summary but are generally defined by the relevant standards and protocols.
   • Data Provenance: The studies are internal company verification and validation studies conducted by Cybersonics, and external validation performed by Ethox for sterilization. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as there is no mention of a "ground truth" derived from expert consensus interpretation of medical images or clinical cases. The "ground truth" for the engineering and sterilization studies is established by the specifications in the standards themselves, physical measurements, and biological indicator results.

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

   • Not applicable, as no expert adjudication process is described.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a physical, invasive surgical tool (lithotripter), not an AI-powered diagnostic or interpretive device. Therefore, the concept of "human readers improve with AI assistance" is not relevant to this submission.

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

   • Not applicable. This device is a physical instrument, not an algorithm. Its operation inherently involves a human surgeon.

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

   • Engineering/Performance Tests: The ground truth for these tests is defined by the technical specifications, design requirements, and performance parameters outlined in relevant international standards (e.g., IEC 61847) and internal company specifications. This involves objective physical measurements (e.g., drill rate, vibration frequency, temperature).
   • Sterilization Validation: The ground truth is the achievement of a specific Sterility Assurance Level (SAL, typically 10^-6^) as measured by biological indicators and validated against standards like ISO 17665-1, AAMI-TIR, ISO 10993-7, and ANSI/AAMI/ISO 11135-1. EO residuals are compared to allowable limits.

8. The sample size for the training set:

   • Not applicable. This submission does not describe an AI model with a training set. The "training" mentioned refers to the training of sales representatives and users on the device's proper use.

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

   • Not applicable. (See #8)

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