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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 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. The purpose of this 510(k) is to increased the number of validated reprocessing cycles for the reusable handpiece and add the option of a wireless foot pedal.

This is a 510(k) premarket notification for a medical device, the Swiss LithoClast® Trilogy, which is an electrohydraulic lithotriptor used for fragmenting and removing urinary tract calculi. The submission is to address two changes: the addition of an optional wireless foot pedal and an increase in the validated number of reprocessing cycles for the reusable handpiece from 60 to 100.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a single table labeled "Acceptance Criteria and Reported Device Performance" for the overall device's indication. Instead, it describes performance testing related to the changes being submitted in this 510(k). The implicit acceptance criteria are that the device with the changes performs equivalently to the predicate device and meets relevant safety and performance standards.

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

• Wireless Foot Pedal Testing (Software, Electrical Safety, Device Performance): The document does not specify a distinct "test set" in terms of patient data or clinical samples for the wireless foot pedal. The testing described is primarily engineering and bench testing on the device hardware and software itself. Therefore, sample sizes would relate to the number of production units tested, but this detail is not provided.
• Handpiece Lifetime Testing:
  • Sample Size: Twenty (20) handpiece units were tested.
  • Data Provenance: This was bench testing conducted by the manufacturer, not patient data. The country of origin of this data is not explicitly stated but would be from EMS Electro Medical Systems SA, Nyon, Switzerland, or a contract testing facility. This is prospective testing performed for the purpose of this submission.

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

This information is not applicable to the studies described. The "ground truth" for these tests relates to engineering specifications and performance benchmarks (e.g., successful software operation, compliance with electrical safety standards, stone clearance within a specified time). These are not studies involving human interpretation of data for which expert consensus would establish ground truth in a clinical context.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring expert adjudication. The tests were objective engineering and performance verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The changes addressed in this 510(k) are related to an optional wireless foot pedal and increased reprocessing cycles for a handpiece, neither of which involves human readers interpreting cases or AI assistance in a diagnostic or interventional workflow that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The term "standalone" performance typically refers to the performance of an AI algorithm independent of human interaction. This submission does not involve an AI algorithm with such a function. The software validation mentioned for the wireless foot pedal assesses the functional correctness and safety of the embedded software, not its standalone performance in interpreting medical data.

7. The Type of Ground Truth Used:

• Wireless Foot Pedal Testing: The ground truth was based on pre-defined engineering design input requirements and international standards for electrical safety, EMC, and wireless communication (e.g., functional performance specifications, battery life targets, compliance with IEC 60601 series, EN 300 328, EN 62311).
• Handpiece Lifetime Testing: The ground truth was based on performance specifications for stone clearance (i.e., effectiveness in clearing stones in a simulated use set-up within 20% of new handpiece performance) and statistical reliability/confidence targets (95% reliability, 95% confidence for 100 cycles).

8. The Sample Size for the Training Set:

Not applicable. There is no AI model or algorithm being trained with a dataset mentioned in this 510(k) submission. The software validation is for embedded control software, not for an AI/ML component that learns from data.

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

Not applicable, as there was no training set for an AI/ML model.

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

The Swiss LithoClast® Trilogy has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a 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.

The provided text is a 510(k) summary for a medical device called the "Swiss LithoClast® Trilogy". This document primarily focuses on demonstrating substantial equivalence to a predicate device for the purpose of adding new sterilization methods for a reusable handpiece. It does not contain information about a study proving the device meets acceptance criteria related to its clinical performance (e.g., fragmentation and removal of urinary tract calculi) or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested sections regarding clinical performance, expert ground truth, sample sizes for test and training sets, and human reader improvement with AI assistance cannot be extracted from this document.

However, I can extract information related to the sterilization validation, which is the core of this particular 510(k) submission.

Here's a summary of what can be extracted:

1. Table of acceptance criteria and the reported device performance (for sterilization):

2. Sample sized used for the test set and the data provenance: Not applicable. This document describes a sterilization validation, not clinical performance testing on a test set of patient data. The "test set" in this context refers to the items (e.g., handpieces) subjected to the sterilization process. The provenance is internal validation testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a sterilization validation, not a study requiring expert clinical interpretation.

4. Adjudication method for the test set: Not applicable.

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 study was not done, as this document concerns a medical device for stone fragmentation, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used:

• For sterilization: The ground truth for sterilization validation is the scientific standard of achieving a Sterility Assurance Level (SAL) of 10⁻⁶, based on established microbiological testing methods.

8. The sample size for the training set: Not applicable, as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Additional information related to the sterilization validation from the document:

• Sterilization Standard: The validation was conducted in accordance with ISO 14937:2009 "Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices."
• Sterilization Parameters: The recommended sterilization parameters for each H₂O₂ sterilizer were used.
• Sterilizers Validated:
  • STERIS V-PRO 1
  • STERIS V-PRO 60
  • STERIS V-PRO maX
  • STERRAD 100S Short
  • STERRAD NX Standard
• Device Component Subject to Validation: The reusable Trilogy handpiece.

In summary, this document provides evidence for the sterilization efficacy of the reusable handpiece, but not for the clinical performance of the device in fragmenting and removing urinary tract calculi.

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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® Triloqy is an intracorporal lithotripter with three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a 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 twostep 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, or any study details that would allow me to populate the requested table and answer the study-related questions.

The document is an FDA 510(k) clearance letter for the "Swiss LithoClast Trilogy". It describes a special 510(k) submission for an engineering modification to improve the durability of a reusable handpiece. It states that "The revised handpiece met the acceptance criteria of the validation testing," but it does not provide what those acceptance criteria were, what the reported performance was, or any details about the validation study itself.

Therefore, I cannot provide the requested information.

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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 has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a 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 twostep 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 document describes a Special 510(k) submission for the Swiss LithoClast® Trilogy device. The primary purpose of this submission is to add hydrogen peroxide (H2O2) sterilization as an option for reprocessing the reusable handpiece, in addition to the previously validated steam sterilization. Therefore, the acceptance criteria and study described below specifically pertain to the validation of this new sterilization method for the handpiece.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" in terms of a number of handpieces tested for the H2O2 sterilization validation. However, sterilization validation studies typically involve:
* Multiple samples (e.g., biological indicators, inoculated devices) within each test run to demonstrate the killing of a specified number of microorganisms.
* Multiple replicate cycles (e.g., three consecutive successful cycles) to prove reproducibility.

The data provenance is related to the performance of the Swiss LithoClast® Trilogy reusable handpiece when subjected to H2O2 sterilization. Given that this is a Special 510(k) for a manufacturing change (adding a sterilization method), the data would be prospective and generated specifically for this validation study. The location of the test facilities or the country of origin of the data is not specified beyond the applicant being EMS Electro Medical Systems SA in Nyon, Switzerland.

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

This type of study does not involve "experts" establishing a ground truth in the same way clinical diagnostic studies do. The "ground truth" for sterilization validation is fundamentally defined by the successful inactivation of biological indicators (BIs) or inoculated devices, as measured by standard microbiological assays (e.g., lack of growth). The expertise lies in:
* Microbiologists and sterilization engineers who design, execute, and interpret the validation studies according to ISO 14937 and other relevant standards.
* Regulatory affairs personnel who ensure compliance with medical device regulations.

The document does not specify the number or qualifications of these individuals, as this is standard practice in such validation studies.

4. Adjudication Method for the Test Set

Not applicable for a sterilization validation study. The outcome (sterile or not sterile, SAL achieved or not achieved) is determined by objective laboratory testing (microbiological culture results) rather than expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not a diagnostic device or a device whose performance is assessed by human readers. It is a device sterilization validation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the device's functional integrity and sterility post-sterilization, which is inherently part of the validation.

7. The Type of Ground Truth Used

The ground truth used for this sterilization validation is microbiological sterility testing. This involves:
* Inoculating representative devices or biological indicators (BIs) with a known, resistant microorganism (e.g., Geobacillus stearothermophilus for H2O2 sterilization).
* Processing these inoculated items through the sterilization cycle.
* Aseptic retrieval and culture of the BIs or device samples to determine if any viable microorganisms remain.
* The "ground truth" is established by the lack of microbial growth (kill) conforming to the specified SAL (10-6).

8. The Sample Size for the Training Set

Not applicable. This is a sterilization validation study, not a machine learning study that would use training sets.

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

Not applicable, as there is no training set for this type of validation. The ground truth (sterility) is established through standardized microbiological testing methods as described in point 7.

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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 is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a 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 twostep 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 document is a 510(k) premarket notification for the Swiss LithoClast Trilogy, a medical device for fragmenting and removing urinary tract calculi. It is a submission to the FDA to demonstrate the substantial equivalence of the new device to a previously cleared predicate device (Swiss LithoClast Master).

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Note: This document describes a medical device (Electrohydraulic Lithotripter), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study aspects for AI/SaMD (like human reader studies, ground truth establishment for AI, training set details, and specific metrics like sensitivity/specificity for diagnostic AI) are not applicable here. The "study" in this context refers to bench testing and validation to show the physical device performs as intended and is safe.

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device. This means showing the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating that the new device (Swiss LithoClast Trilogy) performs equivalently to the predicate device (Swiss LithoClast Master) across various characteristics and safety requirements. The "performance" is shown through the technical comparison and bench testing results.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table with "reported performance" like one would see for an AI model's diagnostic accuracy. Instead, the acceptance is based on demonstrating that the new device's characteristics and performance fall within acceptable ranges or are equivalent to the predicate.

Here's how we can extract the implicit acceptance criteria and reported "performance" based on the technical comparison and bench testing:

• Fragmentation and stone clearance time (using Begostones)
• Tissue perforation testing (on pig bladder)
• Reusable handpiece/probe qualification
• Electrical safety (IEC 60601-1)
• EMC (IEC 60601-1-2)
• Biocompatibility (ISO 10993-1, -5, -10, -11, etc.)
• Sterilization validation (ISO 11135)
• Shipping & handling (ISTA 1E, 2A)
• Package & sterility after aging (ASTM F1886, EN 868-5, ASTM F1929)
• Functional tests of probes after aging
• Software verification and validation (IEC 62304) |

2. Sample Size for the Test Set and Data Provenance

• Sample Size for the Test Set: Not explicitly quantifiable in terms of "patient cases" as this is a device for physical intervention, not an AI/diagnostic software. The "test set" here refers to the materials and units used in the bench tests:
  • Artificial "Begostones" for fragmentation and stone clearance time. Specific number not stated.
  • Pig bladder tissue for tissue perforation testing. Specific number/amount not stated.
  • Reusable handpieces and probes for qualification testing. Specific numbers not stated.
  • Units used for electrical safety, EMC, biocompatibility, sterilization validation, shipping/handling, package/sterility, and functional tests after aging. These would be specific numbers of device components or completed devices as required by the respective standards.
• Data Provenance: This is all prospective bench testing conducted in a lab setting rather than retrospective patient data.
  • Country of Origin: The applicant is EMS Electro Medical Systems SA, located in Nyon, Switzerland. The testing would have been conducted by the manufacturer or by third-party labs contracted by the manufacturer, following international standards.

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

This concept is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of diagnostic accuracy, as this is a therapeutic device. The "ground truth" for the device's functionality is established by objective engineering measurements against defined performance specifications and validation against relevant international standards.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication (e.g., 2+1, 3+1 for resolving discrepancies in expert interpretations) is used in studies with human interpretation, typically for diagnostic accuracy. For bench testing, results are measured objectively against predefined acceptance criteria, and any deviations would be handled through and engineering non-conformance and investigation process, not adjudication.

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 (comparing human readers with and without AI assistance on various cases) is specific to AI/SaMD, especially in diagnostic imaging. The Swiss LithoClast Trilogy is a therapeutic device (a lithotripter used to break up kidney stones), not a diagnostic AI.

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

No, this is not applicable. The device is a physical electrohydraulic lithotripter, not an algorithm. Bench testing demonstrates its standalone physical performance according to specifications and safety standards.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical measurements and adherence to engineering specifications and international standards. Examples include:

• Physical performance metrics: Stone fragmentation efficiency, stone clearance time, maximum amplitude, energy output levels.
• Safety standards: Electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993 series), sterility (ISO 11135), tissue perforation limits.
• Functional validation: Probes functioning correctly after aging, software performing as designed (IEC 62304).

The "ground truth" isn't a medical outcome like disease presence (pathology) or patient outcomes data, but rather that the device, when used as intended, performs its function safely and effectively according to its design and established benchmarks (like the predicate device and industry standards).

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train a machine learning algorithm. This is a physical medical device. Its "training" is in its design, engineering tolerances, and manufacturing processes, which are validated through testing.

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

This concept is not applicable for the same reason as point 8. There is no concept of a "training set" or "ground truth" for training in the context of a conventional medical device's physical design and performance.

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