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The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.

The EHL is a compact, table-top medical device designed for the fragmentation of biliary calculi. It operates by generating high-voltage electric pulses, which are transmitted through a compatible disposable EHL probe (sold separately) that is inserted into the biliary tract via an endoscope. The device features two operational modes: single pulse and continuous pulse. These electric pulses create hydraulic shock waves in a saline medium, causing fragmentation of biliary stones into smaller pieces that can either be naturally passed or removed endoscopically.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets such criteria.

The document is a 510(k) summary for an Electrohydraulic Lithotriptor (TCS-B3-II) and focuses on demonstrating substantial equivalence to a predicate device (EL27-Compact). It outlines various performance and safety tests conducted but does not provide specific acceptance criteria values or detailed study results in the format requested.

The "Performance Data" section mentions "Stone Fragmentation Test," "Shockwave Pressure Attenuation Test," "Acoustic Characterization Test," "Electrical Safety and Electromagnetic Compatibility (EMC) Testing," and "Software Verification and Validation." However, it only describes what these tests validated or complied with (e.g., "validated the system's ability to generate consistent high-voltage pulses," "tested for compliance with IEC 61846," "tested for compliance with IEC 60601-1"), rather than presenting quantitative acceptance criteria and the device's reported performance against them.

Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details for any specific acceptance criteria from this text.

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The EHL probe is designed for use with Potent Medical Electrohydraulic Lithotripter (TCS-B3-II) for disintegration of concernments in the bile duct.

The SCDG -AS, SCDG -BS, and SCDG CS are sterile, single-use electrohydraulic lithotripsy (EHL) probes. These probes are designed to be used with the Electrohydraulic Lithotripter (TCS-B3-II) for the fragmentation of biliary calculi. The probes deliver low-energy electrical pulses through a dedicated connection to the generator, generating hydraulic shock waves in a saline medium to fragment stones in the biliary tract.

The provided text is a 510(k) summary for a medical device (EHL probe) seeking FDA clearance. It describes the device, its intended use, comparison to a predicate device, and performance data from bench testing. However, it does not contain information about a clinical study involving human subjects or AI algorithms, which is typically where the concepts of "acceptance criteria," "human readers improve with AI vs without AI assistance," "standalone performance," "training set," and "ground truth establishment" would be relevant.

The document primarily focuses on bench testing to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on the device meeting certain engineering specifications and performance characteristics, rather than a clinical trial with specific diagnostic accuracy metrics.

Therefore, many of the requested details about acceptance criteria and study design are not applicable (N/A) based on the provided text.

Here's a breakdown of the information that can be extracted from the document, along with an explanation for the N/A sections:

Acceptance Criteria and Device Performance (Based on Bench Testing)

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one would establish for, say, an AI-powered diagnostic device. Instead, it describes various bench tests conducted to ensure the device meets safety and performance standards comparable to the predicate device. The implicit acceptance criterion for each test is that the probe performs as expected and similarly to the predicate device, demonstrating substantial equivalence.

Study Details (Applicable to Clinical/AI Performance Studies)

As stated, this document describes a 510(k) submission based on bench testing for substantial equivalence, not a clinical study involving human performance or an AI algorithm. Therefore, the following information is not present or applicable:

1. Sample size used for the test set and the data provenance: N/A (No clinical test set described). The testing was bench-based.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth for a test set of clinical data was established).
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set of clinical data requiring adjudication).
4. 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: N/A (No MRMC study or AI component described).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm or standalone performance described).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth in a clinical sense is not applicable here; performance was demonstrated through engineering and material testing against established standards and predicate device performance).
7. The sample size for the training set: N/A (No training set for an AI algorithm described).
8. How the ground truth for the training set was established: N/A (No training set for an AI algorithm described).

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The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.

The EL27-Compact is a device, designed to be used with Walz Elektronik GmbH disposable EHL-Probes for the fragmentation of concrements in the gastroenterology and urology.

A physician inserts and pushes the disposable EHL probe through the working channel of an endoscope and places the tip of the probe in front of the stone surrounded with saline solution. With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones.

The EL27-Compact is a table-top device and consists of the generator itself, the power cord, the footswitch, a probe cable for connection between the device and the EHL-probes.

This document describes the EL27-Compact, an electrohydraulic lithotriptor (EHL) device used for fragmenting concretions in the urinary tract and bile duct.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes performance testing conducted to demonstrate "equivalence to the predicate device" and "comparable effects." The acceptance criterion generally appears to be meeting relevant standards, achieving comparable performance to the predicate device in bench tests, and ensuring biocompatibility and electrical/EMC safety.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of probes, number of plasterboards, etc.) for each bench test. For the EL27-Compact intensity test, it mentions "the 3 devices" (presumably 3 EL27-Compact units) and "3Fr. Probes" (number of probes not specified per device).
• Data Provenance: The document implies that the data is from prospective bench testing conducted by Walz Elektronik GmbH ("The following performance testing was conducted..."). There is no information about the country of origin of the data beyond the manufacturer being in Germany.

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

This type of information is not applicable as the study described is primarily bench testing against engineering specifications and predicate device performance, not a clinical study involving human assessment of ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the study described is primarily bench testing, not a study requiring adjudication of expert interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. The submission focuses on demonstrating substantial equivalence through bench testing to a predicate device.

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

This is not applicable. The EL27-Compact is a medical device that requires a human operator (physician) to operate. It is not an AI algorithm with standalone performance metrics.

7. Type of Ground Truth Used

The "ground truth" for the bench tests was based on:

• Engineering specifications and tolerances: For visual inspection, dimensions, insertion compatibility, and withdrawing force.
• Established biological safety standards (ISO 10993-1): For biocompatibility.
• Comparative physical effects: For shockwave measurement, electrode consumption, and the plasterboard penetration test (comparing the "resulting holes" to another, implicitly the predicate, or expected performance).
• Compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
• Compliance with regulatory guidance for software verification and validation.

8. Sample Size for the Training Set

This is not applicable. The EL27-Compact is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this device.

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The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of renal calculi located in the kidneys and urinary bladder.

The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of calculi located in the kidneys and urinary bladder.

The Northgate Technologies Inc. AUTOLITH® URO-TOUCH System consists of a software controlled, electronic unit (Generator) which generates a single high-voltage pulse or a series of pulses across the tip of a flexible bipolar lithotripter probe. When discharged in 0.9% normal physiological saline solution, these pulses produce sharp, high-amplitude hydraulic shock waves that crack calculi (stones) located inside the body. They are capable of cracking calculi of virtually any size and composition. The objective is to reduce the size of the calculi so that fragments can be removed without major surgery.

The AUTOLITH® URO-TOUCH System includes the following major components:
AUTOLITH® URO-TOUCH Unit/Generator (K130368)
Regulate the discharge voltage and repetition rate of a shot delivered to a connected extender cable and probe. Display the relative power delivered to the probe. Display the number of pulses to be delivered to the probe as requested by the operator. Automatically sense the existence of a plugged-in probe.
Automatically preset start-up values for power and pulses according to the probe type.
Automatically scale power range according to the probe type.
Prohibit discharge of high voltage when the footswitch is activated if an extender cable/probe is not properly connected.
Automatically compares the pulses delivered at the selected power levels and displays when to INSPECT or REPLACE PROBE.
Displays the number of pulses delivered.
Automatic AC Voltage Adjust. For use in all countries.

The AUTOLITH® URO-TOUCH 9 Fr Probe is 54 cm long and is used with a transurethral scope for fragmentation of calculi in the kidneys and urinary bladder.

The 9 Fr Probe, 54 cm long, was previously cleared by K914516 on January 7, 1992. The Extender Cable was cleared by K914517 on June 30, 1992.

The provided document is an FDA 510(k) clearance letter for the Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe. This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing extensive details about the performance of the device or a clinical study proving its effectiveness through specific acceptance criteria.

The submission is for a design change to the device, specifically updating materials to comply with ISO 10993-1:2009 for biological safety. The document does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or diagnostic performance (like an AI/ML device would). Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance and the information provided in this document.

However, I can extract the information that is present and explain why other information is absent based on the nature of this submission.

Device: Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe
Type of Submission: 510(k) Premarket Notification for a design change (material update for biological safety compliance). This is not an AI/ML device.

Acceptance Criteria and Reported Device Performance (as inferred from the document for a materials update)

Since this document is primarily about a material update for a medical device (Electro-Hydraulic Lithotriptor Probe) to comply with biological safety standards, the "acceptance criteria" and "reported device performance" are centered around the biocompatibility and functional equivalence tests, not clinical efficacy or diagnostic accuracy.

• Physical Characteristics: Diameter (9 French), Length (54 cm), Tip Material (Brass) are identical to the predicate (Page 7).
• Power Output: "Power output is discussed further in the Bench Testing section." (Page 7) - While not detailed, the implication in a 510(k) is that it's shown to be functionally equivalent for its purpose. |
  | Risk Assessment | New materials must not introduce new questions of safety or efficacy. | The risk assessment led to the removal of ureter indication due to risk of injury with the 9 Fr probe's power output (4000 PSI) (Page 8). This indicates a proactive risk mitigation. The conclusion states: "The different technological characteristics and information submitted to the FDA do not raise new questions of safety and efficacy and demonstrate that the device is at least as safe and effective as the legally marketed predicate device." (Page 8) |

Information Not Applicable or Not Found in the Provided Document:

The following information would typically be found in a submission for an AI/ML device or a device requiring a clinical efficacy study, but is not present or relevant for this specific 510(k) submission concerning a material update for an electro-hydraulic lithotripter probe.

2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to material testing for biocompatibility and bench testing for functional equivalence, not a clinical data set. There's no clinical "test set" described for performance evaluation in this document.
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. This relates to expert adjudication of clinical data, which is not part of this submission type. Ground truth for biocompatibility and functional tests is established by standardized laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons 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 for AI/ML diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For material tests, ground truth is established by the specifications of the ISO standards and the results of the laboratory tests.
8. The sample size for the training set: Not applicable. There is no AI/ML model or "training set" for this device.
9. How the ground truth for the training set was established: Not applicable for the reasons above.

In summary, this 510(k) pertains to a change in materials for an existing device to meet biological safety standards. The "study" referenced would be the battery of biocompatibility tests performed according to ISO 10993 standards and a comparison to the predicate device through bench testing, not a clinical trial or AI/ML performance evaluation.

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The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal.

Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

This is an FDA 510(k) summary for a medical device (Swiss LithoClast® Trilogy), not an AI/algorithm-driven device. Therefore, much of the requested information (such as AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract the relevant acceptance criteria and study information related to the device accessory.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this non-AI device modification):

1. Sample size used for the test set and the data provenance: Not specified in the document. The testing involved evaluating the sterile barrier system of the handpiece when sterilized with the Steri Holder. The document does not provide details on the number of handpieces or sterilization cycles tested, nor the provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device modification, ground truth would typically be established through standardized sterilization validation protocols and integrity testing, not "experts" in the context of diagnostic interpretation.
3. Adjudication method for the test set: Not applicable in the context of expert consensus. Performance testing results are typically evaluated against pre-defined engineering and sterility validation standards.
4. 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 document pertains to a medical device (lithotripter accessory), not an AI diagnostic or assistive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used: For this specific modification, the "ground truth" would be established by the validated integrity of the sterile barrier system after sterilization, assessed through standard sterility and packaging integrity tests (e.g., visual inspection, dye penetration, microbial ingress tests). The document states the testing was to verify "no adverse impact on the handpiece sterile barrier system."
7. The sample size for the training set: Not applicable. There is no training set for an AI algorithm.
8. How the ground truth for the training set was established: Not applicable. There is no training set for an AI algorithm.

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UreTron PF Series Probes are to be used with UreTron Multi Probe Lithotripsy System. UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Not Found

This FDA 510(k) summary does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study design. This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device, rather than a clinical trial report or a summary of performance data.

Here's what can be inferred and what information is missing:

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

• Missing. This document does not specify any quantitative acceptance criteria or report device performance data against such criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, not necessarily on meeting pre-defined performance metrics articulated in this letter.

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

• Missing. No information on sample size, data provenance, or study type (retrospective/prospective) of any test set is provided.

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)

• Missing. No information about experts or ground truth establishment is included.

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

• Missing. No information regarding adjudication methods is provided.

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 / Missing. This device (UreTron PF Series Probes for lithotripsy) is an electrohydraulic lithotriptor probe, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant. The document does not indicate any AI component.

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

• Not applicable / Missing. As above, this is a medical device for treatment, not an algorithm.

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

• Missing. This document does not mention any ground truth associated with performance evaluation.

8. The sample size for the training set

• Not applicable / Missing. There is no indication 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 / Missing. This information is not relevant for this type of device and is not present in the document.

Summary of available information from the document:

• Device Name: UreTron PF Series Probes
• Intended Use: Used with UreTron Multi Probe Lithotripsy System for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
• Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
• Regulatory Class: Class II
• Product Code: FFK
• Regulation Name: Electrohydraulic Lithotriptor

To obtain the detailed performance data and study design information, one would typically need to refer to the full 510(k) submission, which is not publicly released in its entirety but may have a publicly accessible summary (510(k) Summary). This letter only confirms the clearance.

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The UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the UreTron MultiProbe Lithotripter System. It acknowledges the device's substantial equivalence to existing devices and outlines regulatory compliance requirements.

This document does not contain any information regarding:

• Acceptance criteria for device performance.
• Details of a study that proves the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used or details about a training set.

Therefore, I cannot fulfill your request based on the provided input.

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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 AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi.

The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi. Both devices operate just like the legacy (predicate) AUTOLITH® device. The units are softwarecontrolled, electronic devices capable of cracking calculi of virtually any size and composition. The devices are table-top units that connect to a disposable probe that is used in the working channel of an endoscope. A surgeon places the tip of the probe near the surface of the calculus/stone under endoscopic visualization. The physician then steps on a pneumatic foot pedal to activate the device. The electronic circuitry of the device generates a single high-voltage pulse or a series of pulses across the tip of the disposable flexible bipolar lithotripter probe. The discharge (in 0.9% normal physiological saline) produces sharp, high-amplitude hydraulic shockwaves that help to fragment the calculus/stone so it can be passed or removed without major surgery.

The provided text describes a 510(k) summary for the AUTOLITH® TOUCH / AUTOLITH® URO-TOUCH lithotripters, stating their substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.

This document is for a medical device (lithotripter) that is not an AI/ML device, but rather a hardware device with software controls and slight modifications from its predecessor. Therefore, the questions related to AI/ML specific studies (like sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The "Performance Data" section briefly mentions "Both Design Verification and Design Validation have been completed" and that "Non-clinical bench tests have been performed to prove substantial equivalence in the overall performance characteristics of the device."

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations for AI/ML-specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance acceptance criteria for a novel AI/ML algorithm. The core acceptance criterion for substantial equivalence in this context is that the new device produces the same pressure wave output as the current device.

The design goal was to produce a modern, simpler, and more reliable version of the current device while ensuring it "produces the same pressure wave output as the current AUTOLITH® device."

"By design, the 6kV output capacitor is the main contributor in determining the voltage waveform applied to the probe. The new device incorporates the same 6kV output capacitor as the current device and uses modern circuitry to produce the same voltage waveform for the probe." |
| Biological Safety | Materials used are "not toxic and have been previously used to manufacture other medical devices." Tests include: Cytotoxicity, Sensitization (Kligman Maximization), Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity Test, Pyrogenicity, Latex, DEHP, all passing ISO 10993-1 requirements. |
| Electrical and Functional Safety | The device functions as intended with features such as regulating discharge voltage, displaying power and pulse count, automatically sensing probes, preset start-up values, prohibiting discharge without proper connection, and displaying when to replace probes. The "Modifications have no impact on the application or efficacy of the accessories." |

Study Details:

The study referenced is the "Comparison testing" mentioned in the "Substantial Equivalence" section. This was a non-clinical bench test.

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

• Sample Size: Not specified for the bench testing. The testing would likely involve multiple iterations or samples of the device and various probes to ensure consistent output.
• Data Provenance: Not applicable as it's a non-clinical bench test of physical output characteristics, not human or clinical data.

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

• Not Applicable. This is a bench test comparing physical output characteristics (voltage waveform and pressure wave) to a predicate device. Ground truth is established by objective engineering measurements against the predicate device's known output, not expert human interpretation.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device. While the device has software controls, its performance is measured by its physical output as a lithotripter, not an AI algorithm's diagnostic or predictive capabilities.

7. The type of ground truth used

• Objective measurement against predicate device's output. The "ground truth" was the voltage waveform output and pressure wave output of the already cleared predicate AUTOLITH® device. The new system was designed to replicate this physical output.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device was engineered to replicate the predicate's performance.

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

• Not Applicable. See point 8.

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The SWISS LITHOBREAKER is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

The EMS SWISS LITHOBREAKER is a handheld, standalone, battery operated intracorporeal lithotripter which uses a mechanical impact drive to fragment urinary tract calculi in the kidney, ureter, and bladder. The device generates around 3 impacts in continuous mode per second which are transmitted through the probes on the stones or a lower frequency by "single-pulse" mode, depending on the activation time of the button. The probes are introduced into the working channels of suitable endoscopes. The energy is sustained and stable throughout the life of the battery and the frequency drops only at the end of the battery life. An optional suction handpiece allows extraction of fragmented stones.

The proposed device consists of the following:

• Handpiece including powerpack .
• LithoClast probes, non-sterile reusable and sterile single use .
• LithoVac lv3 suction system with suction tubes .

The SWISS LITHOBREAKER is also supplied with accessories for cleaning (endcap), periodic maintenance (O-rings), probe accessories (interface and probe guide), AAA batteries and sterile drapes.

The provided 510(k) summary for the E.M.S. Electro Medical Systems SA SWISS LITHOBREAKER outlines the device's technical specifications and a summary of non-clinical performance testing. However, it does not include a table of specific acceptance criteria and detailed reported device performance for each criterion, nor does it describe a study that explicitly "proves the device meets the acceptance criteria" in a typical clinical study format.

Based on the provided document, here's an analysis of the requested information:

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

The document describes performance specifications that the device fulfills, but does not provide a quantitative table of acceptance criteria with corresponding performance metrics. It generally states that the device "fulfills the prospectively defined performance specifications" and that testing "demonstrated that the SWISS LITHOBREAKER fulfills the prospectively defined performance specifications."

The performance aspects tested and considered in comparison to predicate devices were:

• Probe Tip Displacement
• Probe Tip Velocity
• Stone Breakage/Clearance
• Stone Displacement (Retropulsion)
• Energy Output

Without specific numbers or target ranges, a formal table cannot be created from the provided text. The document asserts that the results of this testing confirm that the SWISS LITHOBREAKER is substantially equivalent to the predicates based on these parameters.

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

The document does not specify the sample size used for the non-clinical performance testing. It also does not specify the data provenance in terms of country of origin or whether the testing was retrospective or prospective, although the statement "prospectively defined performance specifications" implies the criteria were set before testing. The testing appears to be laboratory-based rather than involving human subjects.

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)

This information is not applicable as the described testing is non-clinical (laboratory-based performance testing of mechanical characteristics) and does not involve establishing ground truth from expert assessments of medical images or patient outcomes.

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

This information is not applicable as the described testing is non-clinical and does not involve expert review or adjudication of results.

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 as the device is a medical instrument (lithotripter) and not an AI-assisted diagnostic tool for human readers.

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

The device itself is a standalone medical instrument. The performance testing described (Probe Tip Displacement, Probe Tip Velocity, Stone Breakage/Clearance, Stone Displacement (Retropulsion), Energy Output) inherently evaluates the device's standalone mechanical performance. There is no "algorithm" in the context of AI being evaluated here; it's a mechanical device.

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

For the non-clinical performance testing, the "ground truth" would be established by physical measurements and standardized testing methodologies using calibrated equipment and reference materials (e.g., artificial stones for stone breakage/clearance tests). It would not involve expert consensus, pathology, or outcomes data, as these are clinical measures.

8. The sample size for the training set

This information is not applicable as the SWISS LITHOBREAKER is a mechanical medical device, not an AI model that requires a training set.

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

This information is not applicable as the SWISS LITHOBREAKER is a mechanical medical device, not an AI model that requires a training set.

In summary:

The 510(k) summary primarily relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI-specific evaluation metrics. The "acceptability criteria" are implied through the fulfillment of "prospectively defined performance specifications" and comparison to known predicate devices on specific mechanical performance characteristics (probe tip displacement, velocity, stone breakage, retropulsion, energy output), without providing granular data or specific numerical targets. The basis for clearance is demonstrating that the new device performs comparably to already cleared devices.

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