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510(k) Data Aggregation
(30 days)
Swiss LithoClast Trilogy
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No adverse impact on the handpiece sterile barrier system (pouch or wrap) during the steam sterilization process due to the use of the new Steri Holder accessory. | "Performance testing was conducted to verify that use of the Steri Holder during steam sterilization has no adverse impact on the handpiece sterile barrier system (pouch or wrap) during the steam sterilization process." (Implicitly, the device met this criterion by passing the testing). |
Study Details (as applicable to this non-AI device modification):
- 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.
- 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.
- 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.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- 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."
- The sample size for the training set: Not applicable. There is no training set for an AI algorithm.
- 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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(28 days)
Swiss LithoClast Trilogy
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)
Swiss LithoClast Trilogy
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)
Swiss LithoClast Trilogy
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)
Swiss LithoClast Trilogy
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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