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

The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.

The provided document is a 510(k) premarket notification for a medical device called the ShockPulse-SE Lithotripsy System. It outlines the regulatory review process and confirms the device's substantial equivalence to a predicate device.

However, this document does not contain the detailed information necessary to answer your specific questions related to acceptance criteria, study design for device performance (especially for AI/ML models), sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This K171024 submission focuses on demonstrating substantial equivalence based on the device's technological characteristics, intended use, and general performance testing (electrical safety, EMC/EMI, biocompatibility, etc.). It describes a physical medical device (a lithotripsy system for kidney stones), not an AI/ML-driven diagnostic or therapeutic system.

Therefore, I cannot provide the requested information for the following reasons:

• No AI/ML Component: The ShockPulse-SE Lithotripsy System is an electrohydraulic lithotriptor. There is no mention of any AI or machine learning component in its design or function. Your questions are specifically tailored to the evaluation of AI/ML devices.
• Performance Data Limitations: The document lists general performance tests (e.g., "Mass removal rate," "Drill rate," "Displacement," "Frequency") and states "Pass" for all of them. However, it does not provide:
  • Specific acceptance criteria values (e.g., "Mass removal rate must be > X mg/s").
  • The detailed methodology of these performance tests.
  • Any information on "test sets," "training sets," "ground truth," "expert consensus," "adjudication," or "human reader studies" as these are not relevant to the type of device being described.

In summary, the provided text does not contain the information requested in your prompt because it describes a traditional medical device, not an AI/ML system. If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested details.

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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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The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.

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.

The provided document describes a Special 510(k) submission for the CyberWand Sterile Probe Set, focusing on its substantial equivalence to previously cleared devices and supporting a five-year shelf life. The study detailed is specifically for package integrity and shelf-life validation, not for the device's clinical performance in fragmenting urinary tract calculi.

Therefore, many of the typical acceptance criteria and study components related to clinical efficacy or AI performance (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable to this submission.

Here's the relevant information based on the provided text, primarily concerned with the device's shelf life and package integrity:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Testing was conducted on "representative samples" of the device. The exact number of samples is not specified in the document.
• Data Provenance: Not explicitly stated, but implies internal testing by Cybersonics, Inc. The document does not mention the country of origin for the data, nor whether it was retrospective or prospective in the sense of clinical data. For package integrity, it was prospective in the sense of aging tests.

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

• Not applicable. This study is for package integrity and shelf life, not clinical performance requiring expert ground truth on medical outcomes.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 typically relate to expert review of clinical cases. This study involved physical and material property testing, not subjective expert judgment of clinical data.

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 a study comparing human performance with or without AI assistance, nor is it an MRMC study.

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

• Not applicable. This device is a medical instrument (lithotriptor probe), not an AI algorithm.

7. The type of ground truth used:

• For shelf life and package integrity, the "ground truth" was defined by objective physical and material property measurements and industry/internal standards for package integrity (e.g., passing specific thresholds for burst strength, peel strength, dye penetration).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study that would involve a training set.

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

• Not applicable. As this is not an AI/machine learning study, there is no training set or associated ground truth establishment method.

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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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The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.

The CyberWand Dual Ultrasonic Lithotripsy System is an electromechanical device used to fragment and aspirate calculi. The system consists of the generator unit, transducer handpiece, footswitch, probe sets and cleaning stylets.

The Semi-Flexible Probe is constructed entirely of stainless steel and is packaged with a stainless steel cleaning stylet. The probe has a working length of 58.5 cm and an outer diameter of 1.65 mm; it is is intended to be used primarily with semi-rigid or ridged scopes (cystoscopes, nephroscopes and ureteroscopes) which have a working channel between 5 and 7 French in diameter.

The probe is for provided non-sterile and is for single-patient use.

The provided text is related to a 510(k) submission for the Cybersonics CyberWand® Lithotripter and its Hollow Semi-Flexible Ureteral Probe. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies to establish new safety and effectiveness criteria as would be typical for novel devices.

Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test sets with ground truth, MRMC studies, training set details) are not applicable or not present in the provided 510(k) summary because the device is a modified version of an already cleared predicate device. The focus is on demonstrating that the modifications do not raise new questions of safety and effectiveness and that the modified device performs as intended.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format for clinical efficacy. The device is a "modified probe" intended to be equivalent to a predicate. The "acceptance criteria" here refer more to meeting functional and performance requirements for a medical device rather than clinical outcome measures as you might find for a diagnostic AI.

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

• Sample Size for Test Set: Not specified for clinical efficacy. The summary mentions "representative samples of the device" for durability and stone breakage testing, implying in-vitro or bench testing, not a clinical test set with patient data.
• Data Provenance: Not applicable for a clinical test set. The functional and performance testing would have been conducted internally by Cybersonics.

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

• This is not applicable as the provided summary discusses a physical medical device (lithotripter probe) and its functional performance, not an AI or diagnostic device that requires expert-established ground truth on a test set of patient data.

4. Adjudication method for the test set

• This is not applicable for the same reasons as point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where human readers interpret patient cases. This submission is for a surgical instrument.

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

• This is not applicable. The device is a human-operated surgical instrument, not an algorithm.

7. The type of ground truth used

• For the functional and performance testing, the "ground truth" would be the engineering specifications and performance standards established by Cybersonics for durability and stone breakage. This is not clinical ground truth like pathology or outcome data.
• For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• This is not applicable as there is no AI algorithm being developed or trained for this device.

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

• This is not applicable as there is no AI algorithm or training set discussed.

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The CyberWand™ Lithotripter with STERILE Probes is intended to be used for the intracorporeal fragmentation of urinary tract calculi in the kidney, ureter, bladder and biliary tracts.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the CyberWand™ Lithotripter with STERILE Probes. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about specific acceptance criteria or a study proving the device meets particular performance metrics.

The letter focuses on the regulatory approval process based on substantial equivalence, rather than detailing the results of performance studies against pre-defined acceptance criteria. Therefore, I cannot extract the requested information from this document.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive 510(k) submission that includes performance data.

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The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

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 piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.

The provided K052135 document describes the Cybersonics Cyberwand Dual Probe Lithotripter, which is intended for the percutaneous fragmentation and removal of kidney stones. The basis for substantial equivalence is primarily against other legally marketed ultrasonic lithotripters, specifically the EMS Swiss Lithoclast Ultra (K012445) and the Karl Storz Calcuson (K973251).

Acceptance Criteria and Study Details

The document does not explicitly state "acceptance criteria" as a set of quantified thresholds. Instead, it presents a comparison of technological characteristics and performance metrics, particularly drill rate, against predicate devices to demonstrate substantial equivalence. The implication is that if the Cyberwand performs "as well or better" than the predicates, it meets the unstated acceptance criteria for safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document primarily focuses on demonstrating that the Cyberwand's technological characteristics are comparable to predicate devices. For performance, the "acceptance criterion" appears to be that its drill rate is comparable to or better than predicate devices. The study results show the Cyberwand had a faster mean drill rate than all listed predicate devices.

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

• Sample Size (Drill Rate Study):
  • Cybersonics Cyberwand: 10 stones
  • LithoClast Ultra: 10 stones
  • Olympus LUS-2: 25 stones
  • Circon-ACMI USL-2000: 25 stones
  • Karl Storz Calcuson: 15 stones
  • Olympus LUS-1: 12 stones
  • Richard Wolf Model 2271-004: 10 stones
• Data Provenance: The drill rate data was supplied by Indiana University School of Medicine. This suggests a prospective study specifically designed for this comparison.

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

This information is not provided in the document. The "ground truth" for the drill rate study appears to be the objective measurement of time taken to drill artificial stones. There is no mention of experts establishing a subjective ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The drill rate study involves objective measurements of time, not subjective assessments requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a medical instrument (lithotripter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving 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

• Yes, a standalone performance study was done in the form of the drill rate comparison. The "algorithm" here is the device itself, and its performance (drill rate) was measured independently without human intervention influencing the fragmentation process, beyond operating the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth for the drill rate study was objective performance measurement based on artificial stone fragmentation time. This is a direct physical measurement, not dependent on expert consensus, pathology, or clinical outcomes data.

8. The Sample Size for the Training Set

• Not applicable/provided. This submission does not describe a machine learning or AI algorithm that would require a training set. The device is a physical electromechanical lithotripter.

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

• Not applicable/provided for the reasons stated above (no AI/ML training set).

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