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

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

The proposed device consists of the following:

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done as the device is a medical instrument (lithotripter) and not an AI-assisted diagnostic tool for human readers.

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

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

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

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

8. The sample size for the training set

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

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

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

In summary:

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

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