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510(k) Data Aggregation
(206 days)
FEO
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.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Wireless Foot Pedal - Software Validation | The software in the wireless foot pedal and dongle must be validated commensurate with a moderate level of concern and compliant with IEC 62304 Edition 1.1 2015-06. All unit, integration, and system level tests must meet acceptance criteria. | All tests met the acceptance criteria and were passed, demonstrating compliance with IEC 62304. |
| Wireless Foot Pedal - Electrical Safety & EMC | The Swiss LithoClast Trilogy, when operated by the wireless foot pedal, must comply with IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014. The Wireless Foot Pedal Kit must also comply with EN 300 328 V2.2.2 (2019-07) and EN 62311:2008. | Demonstrated compliance with all specified electrical safety and EMC standards. |
| Wireless Foot Pedal - Device Performance Testing | The wireless foot pedal and dongle must meet the design input requirements for functional performance, battery performance, mechanical integrity, dongle connection/disconnection integrity, chemical resistance, expected use lifetime, and RF quality of service and coexistence. | All test results demonstrated that the wireless foot pedal and dongle meet the design input requirements. |
| Handpiece Lifetime Testing (Reprocessing Cycles) | Handpieces must meet performance specifications and be effective in clearing stones in a simulated use set-up within 20% of the time needed using new handpieces (at time 0) after 133 cleaning, disinfection, and steam sterilization cycles. This must demonstrate validation for 100 reprocessing cycles with 95% reliability and 95% confidence. | Performance testing confirmed that handpieces met performance specifications and were effective in clearing stones within 20% of the time needed by new handpieces after 133 reprocessing cycles. The conclusion was validation for 100 reprocessing cycles with 95% reliability and 95% confidence. |
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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(28 days)
FEO
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):
| Acceptance Criterion (for sterilization) | Reported Device Performance (for sterilization) |
|---|---|
| Achievement of Sterility Assurance Level (SAL) 10⁻⁶ | Demonstrated SAL 10⁻⁶ for each sterilizer |
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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(35 days)
FEO
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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(28 days)
FEO
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For the Handpiece: Successful validation of H2O2 sterilization method to achieve a sterility assurance level (SAL) of 10-6 in accordance with ISO 14937:2009 using the STERRAD 100NX sterilizer on the Standard cycle, ensuring the device remains safe and effective.** | Sterilization validation was conducted using the STERRAD 100NX sterilizer on the Standard cycle. The study demonstrated the achievement of sterility assurance level (SAL) 10-6 for the Swiss LithoClast® Trilogy reusable handpiece. This indicates the new sterilization method effectively renders the handpiece sterile to the required standard without compromising its functionality or safety. The submission concludes that "the Swiss Lithoclast® Trilogy reusable handpiece, when sterilized using the STERRAD 100NX H2O2 sterilizer, is substantially equivalent to the handpiece when sterilized using steam." |
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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(97 days)
FEO
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:
| Characteristic/Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate (fragmentation of urinary tract calculi) | "Fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder" (Substantially equivalent, with added "removal") |
| Device Components: | ||
| - Console (Microprocessor, I/O, Dimensions, Weight, Power Supply) | Equivalent/Acceptable ranges compared to predicate. Must not introduce new safety concerns. | All deemed "Same" or "Substantially equivalent" to predicate, with noted differences (e.g., touchscreen vs. rotary knobs, slight dimension/weight changes). |
| - Handpiece (Types, Material, Sterilization) | Equivalent/Improved functionality without compromising safety; same material, same sterilization. | Single handpiece delivers both energy types (improvement); Same PEEK material; Same re-usable, pre-vacuum, steam sterilization. |
| - Probes (Types, Material, Diameters, RFID, Sterilization) | Single probe delivering both energy types; same material for ultrasound probe; equivalent diameter range; RFID tag acceptable; Same sterilization. | Single probe provides both ultrasound/ballistic; Same 316L stainless steel for ultrasound probe; Equivalent range of diameters (1.1-3.9mm vs. 0.8-3.8mm); RFID tag for tracking (acceptable addition); Same sterilization. |
| - Foot Pedal | Improved user interface without compromising control or safety. | Single pedal, two-step for suction and energy (simplified); Substantially equivalent. |
| - Suction | Equivalent functionality and safety. | Options of pinch valve or peristaltic pump; Substantially equivalent. |
| - Stone Catcher | Same functionality. | Optional component; Same product. |
| Operating Modes: | ||
| - Ultrasound Mode (Frequency, Amplitude, Output Power) | Same frequency/amplitude; acceptable output power adjustment range. | 24 kHz frequency; 60 μm max amplitude; Adjustable from 10%-100% (Substantially equivalent). |
| - Ballistic Mode (Energy Type, Output Power, Operating Modes, Repetition Rate) | Energy type difference must be demonstrated safe and effective; acceptable output power; justified mode changes; same repetition rate. | Different energy source (electromagnetic field vs. compressed air) - demonstrated safe/effective via testing; Adjustable from 10%-100% (Substantially equivalent); Multiple shot mode only (single shot eliminated as rarely used); 1-12 Hz repetition rate (Same). |
| Bench Testing (Safety/Performance) | Meets relevant international standards and performance metrics for all tests. | All listed tests were performed and results deemed acceptable to support substantial equivalence: |
- 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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(138 days)
FEO
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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(76 days)
FEO
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:
| Acceptance Criteria / Performance Goal | Reported Device Performance |
|---|---|
| Stone Breakage Performance | |
| CyberWand II 3.76 probe drills through a stone at least 10% faster than CyberWand I 3.76 Dual Probe. | The CyberWand II 3.76 probe drills through a stone at least 10% faster than the CyberWand I 3.76 Dual Probe. (Met) |
| CyberWand II 3.76 probe removes mass at least 20% faster than CyberWand I 3.76 Dual Probe. | The CyberWand II 3.76 probe removes mass at least 20% faster than the CyberWand I 3.76 Dual Probe. (Met) |
| CyberWand II 1.65 probe has less impact force than LithoClast pneumatic ureteral probe. | The CyberWand II 1.65 probe has less impact force than the LithoClast pneumatic ureteral probe. (Met) |
| Smallest probe size (0.97 mm) equivalent stone breakage. | Supported by stone breakage measurements and identification of a reference device (K111058, Med-Sonics Corp. UreTron Multi Probe Lithotripter) with an 0.8 mm ultrasonic probe. (Met by comparison to a cleared device) |
| Transducer and Torque Wrench Life Cycle (50 Cycles) | |
| Performance (Mass Removal, Drill Rate, Probe Tip Displacement) does not degrade. | Evaluated, implied to be met as it states performance does not degrade over 50 simulated use cycles. |
| Functionality (Suction Control, Button Activation Switches) remains. | Evaluated, implied to be met as it states every aspect of the transducer is functional after 50 simulated use cycles. |
| Safety (Electrical Safety - Patient Leakage Current) remains. | Evaluated, implied to be met as it states every aspect of the transducer is functional after 50 simulated use cycles. |
| Appearance Quality (Black Anodize, Laser Etching) does not degrade. | Evaluated, implied to be met as it states every aspect of the transducer is functional after 50 simulated use cycles. |
| Probe Reliability and Reusability | |
| Probes are functional after a single simulated use (5x typical use time). | Probes are functional after a single simulated use, capable of 5x typical use time. (Met - Note: Probes are to be labeled single use) |
| IEC 61847 Evaluation | |
| Output characteristics of CyberWand II system compared to CyberWand I 3.76 mm dual probe. | Demonstrated. |
| Less probe tip displacement than predicate (safe and substantially equivalent). | Less probe tip displacement (101 microns peak-to-peak) compared to the predicate CyberWand I (102 microns peak-to-peak). (Met) |
| Tissue Perforation Testing (Safety) | |
| CyberWand consistently induces less kidney tissue damage than LithoClast Ultra. | The CyberWand consistently induced less kidney tissue damage than the LithoClast Ultra using a visual assessment methodology (on predicate device). ShockPulse SE system designed and tested to have equal or less maximum tip amplitude than CyberWand I, and tested in porcine model with no significant tissue damage. (Met by lineage and animal study) |
| Smallest probe (0.97 mm) equivalent tissue perforation potential. | Supported by identification of a reference device (K111058, Med-Sonics Corp. UreTron Multi Probe Lithotripter) with an 0.8 mm ultrasonic probe. (Met by comparison to a cleared device) |
| Torque Wrench Performance | |
| Consistent torque specification of 35-40 inch pounds. | Demonstrated a consistent torque specification of 35-40 inch pounds. (Met) |
| Generator and Footswitch Life Cycle | |
| Generator useful life of 7 years. | Demonstrated a useful life of 7 years for the generator. (Met) |
| Footswitch durability and IPX6 rating. | Demonstrated footswitch durability and IPX6 rating. (Met) |
| Shipping and Handling Durability | |
| System functionality after rigorous simulated shipping and handling. | Demonstrated system functionality after being run through rigorous simulated shipping and handling. (Met) |
| Noise Evaluation | |
| Less noise output compared to CyberWand I. | Demonstrated less noise output of the CyberWand II compared to the CyberWand I. (Met) |
| Surface Temperature Profile | |
| Surface temperature stabilizes at an acceptable level (IEC 60601-1) with aspiration. | Demonstrated that the surface temperature of the transducer stabilizes at an acceptable level while running with aspiration. (Met) |
| Surface temperature stabilizes at a lower temperature than CyberWand I (with and without aspiration). | Demonstrated that the surface temperature of the CyberWand II transducer stabilizes at a lower temperature than the CyberWand I while running with and without aspiration. (Met) |
| Setup Steps | |
| Fewer setup steps for CyberWand II compared to CyberWand I (37.5% fewer). | Demonstrated the number of setup steps is less for the CyberWand II as compared to the CyberWand I (37.5% fewer steps). (Met) |
| Usability Verification and Validation | |
| Ability to fragment simulated urinary tract calculi (3.76, 1.65, 0.97 probes). | Demonstrated the ability for the CyberWand II 3.76, 1.65, and 0.97 to fragment simulated urinary tract calculi. (Met) |
| Usability of IFU and labeling. | Demonstrated the usability of the CyberWand II IFU and labeling. (Met) |
| Meets customer needs. | Demonstrated the CyberWand II meets customer needs. (Met) |
| Electrical Safety (IEC 60601-1:2005 3rd Ed.) | Complies with IEC 60601-1:2005 3rd Edition. All testing conducted by Intertek. (Met) |
| EMC (IEC 60601-1-2 ed3.0 and CISPR 11:2009+A1:2010) | Complies with IEC 60601-1-2 ed3.0 and CISPR 11:2009+A1:2010. All testing conducted by Intertek. (Met) |
| Risk Management (ISO 14971) | Compliance with ISO 14971 established by inspection (desktop audit) of the Risk Management File. (Met) |
| Software Validation (FDA Moderate Level of Concern) | Performed according to FDA's Moderate Level of Concern recommendations. (Met) |
| Sterilization Validation | |
| SPL-PD376 probe (EO sterilization) | Packaging and sterilization validations apply to SPL-PD376 probes, confirmed by MOOG Medical Device Group. (Met by comparison to predicate data K120303) |
| 5-year shelf life sterile packaging (SPL-PD376 probe) | Assured with accelerated and real-time aging and subsequent testing; supported by data in K132795. (Met) |
| Cleaning efficacy for non-sterile components | Validated manual cleaning method demonstrated. (Met) |
| Steam efficacy (US steam sterilization cycle) | Demonstrated efficacy at the US steam sterilization cycle (4 minutes at 132 degrees C, 20 minute dry time) for various components. (Met) |
| Dry time validation (20 minute dry time for US steam sterilization) | Demonstrated adequate 20 minute dry time for a US steam sterilization cycle for various components. (Met) |
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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(73 days)
FEO
The Fibra Sonics LithoSonic Model LS-2000 Ultrasonic Lithotripsy System is intended to fragment urinary calculi in the kidney, ureter, and bladder.
Not Found
This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details (sample size, provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.
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(297 days)
FEO
These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.
Not Found
The Karl Storz Calcuson Ultrasonic Lithotriptor is intended for the fragmentation of renal, ureteral, and bladder calculi.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for the Calcuson Ultrasonic Lithotriptor in terms of specific performance metrics (e.g., fragmentation rate, stone clearance rate, or power output). The 510(k) submission process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than defining new performance benchmarks for a novel device.
However, the "Indications for Use" section implicitly sets the functional acceptance criterion: The device must be capable of fragmenting renal, ureteral, and bladder calculi.
The reported device performance, based on the FDA's clearance, is that it is "substantially equivalent" to legally marketed devices for the stated indications. This implies that the device is expected to perform comparably to existing ultrasonic lithotriptors in terms of its ability to fragment the specified types of calculi. Without a detailed study report, specific numerical performance data for the Calcuson itself is not provided in this regulatory document.
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) clearance letter and associated documents do not include information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission where, if a study was conducted, it would primarily focus on demonstrating substantial equivalence, often through bench testing, animal studies, or comparison to existing clinical data of the predicate device, rather than a full-scale clinical trial to establish novel performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. As mentioned, a formal clinical study with ground truth established by experts is not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there is no specific test set or clinical study described within the provided regulatory information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size related to human reader improvement with or without AI assistance. This device is an ultrasonic lithotriptor, a surgical tool, and not a diagnostic imaging device that would typically involve human "readers" or AI assistance in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The Karl Storz Calcuson is a surgical instrument operated by a qualified surgeon, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is irrelevant.
7. Type of Ground Truth Used:
Given the nature of the device and the provided document, the "ground truth" for the 510(k) submission would likely be established through:
- Bench testing: Demonstrating the ability to fragment various types of calculi in a controlled environment.
- Performance specifications: Meeting engineering and design specifications for power output, frequency, and other physical characteristics suitable for lithotripsy.
- Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate device(s).
No direct clinical "ground truth" in the form of pathology, expert consensus on images, or outcomes data from a de novo clinical trial is described in this regulatory filing.
8. Sample Size for the Training Set:
Not applicable. This is a medical device, an ultrasonic lithotriptor, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
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