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

The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. The purpose of this 510(k) is to increased the number of validated reprocessing cycles for the reusable handpiece and add the option of a wireless foot pedal.

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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The DolorClast® Radial is indicated for:

• Relief of minor muscle aches and pains
• Temporary increase in local blood circulation
• Activation of connective tissue

The DolorClast® Radial is a portable radial pressure pulse device with an integrated air compressor. The DolorClast® Radial system is composed of the DolorClast® Radial console, handpiece, interchangeable applicator heads, and optional cart. Swiss DolorClast® Gel, previously approved under P050004, is also provided for coupling the treatment applicator to the patient's skin.
The DolorClast® Radial console generates and controls the pressure pulse frequency and intensity. Air pressure from the console drives a projectile within the handpiece against the applicator head to generate the pressure pulses at the set frequency and intensity. Device activation is done by the practitioner via a trigger button on the handpiece. The applicator at the distal end of the handpiece transmits the radial pressure pulses to the targeted tissues via the coupling gel applied to the treated skin.

This document is an FDA 510(k) summary for a medical device (DolorClast® Radial), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance. Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment for AI, MRMC studies, expert qualifications) are not applicable or not present in this type of regulatory submission.

However, based on the provided text, I can extract information related to the device's functional performance testing against internal protocols.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several functional performance tests and generally states that "All tests were passed," indicating the device met internal EMS protocols. Specific numerical acceptance criteria are generally not provided in this summary, but the reported performance is that the device met those criteria.

Note: The document states "Averaged across all applicator sizes" for derived focal acoustic pulse energy.

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

• Sample Size for Test Set: Not explicitly stated for any of the performance tests. The testing described appears to be engineering verification and validation, likely involving a limited number of test units or prototypes.
• Data Provenance: The origin of the data is stated as "internal EMS protocols" and "internal EMS testing." It is prospective testing conducted specifically for this regulatory submission on the device itself. No mention of geographical data origin (e.g., country) is made as it's not a clinical data study.

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

Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts. The "ground truth" for these tests refers to engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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

Not applicable. This device is a therapeutic massager, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical therapeutic device, not an algorithm. Its performance is inherent in its physical operation.

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

The "ground truth" effectively used for this regulatory submission is adherence to engineering specifications, internal EMS protocols, and recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, ISTA 2A/3A). For biocompatibility, the "ground truth" was established by prior approval (P050004) of identical materials.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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

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

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

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

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

Acceptance Criteria and Reported Device Performance

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

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

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

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

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal.

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

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

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

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

Here's a summary of what can be extracted:

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC study was not done, as this document concerns a medical device for stone fragmentation, not an AI-assisted diagnostic tool.

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

7. The type of ground truth used:

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

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

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

Additional information related to the sterilization validation from the document:

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

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

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

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

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal.

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

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

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

Therefore, I cannot provide the requested information.

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

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

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal.

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

This document is a 510(k) premarket notification for the Swiss LithoClast Trilogy, a medical device for fragmenting and removing urinary tract calculi. It is a submission to the FDA to demonstrate the substantial equivalence of the new device to a previously cleared predicate device (Swiss LithoClast Master).

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

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

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

Acceptance Criteria and Reported Device Performance

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

2. Sample Size for the Test Set and Data Provenance

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on various cases) is specific to AI/SaMD, especially in diagnostic imaging. The Swiss LithoClast Trilogy is a therapeutic device (a lithotripter used to break up kidney stones), not a diagnostic AI.

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

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

7. The Type of Ground Truth Used

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

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

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

8. The Sample Size for the Training Set

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

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

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

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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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The AIR-FLOW MASTER PIEZON combines the functions of an ultrasonic scaler and airpolishing unit within a single chassis. The AIR-FLOW MASTER PIEZON is intended for use in the following dental and periodontal applications:

• Removing supra and subgingival calculus deposits and stains from teeth .
• Periodontal pocket lavage with simultaneous ultrasonic tip movement .
• Scaling and root planing .
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha .
• Plugging for amalgam condensation .
• Amalgam burnishing .
• Preparing, cleaning and irrigating root canals .
• Cavity preparation .
• Cementing inlays and onlays .
• · Retrograde preparation of root canals

The AIR-FLOW MASTER PIEZON is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

The AIR-FLOW MASTER PIEZON can be used for the following cleaning procedures:

• plaque removal for placement of sealants .
• surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers .
• surface preparation prior to placing composite restorations .
• effective plaque and stain removal for orthodontic patients .
• cleaning prior to bonding ortho brackets .
• cleaning implant fixture prior to loading .
• · stain removal for shade determination
• plaque removal prior to fluoride treatment .
• plaque and stain removal prior to whitening procedure .

The AIR-FLOW MASTER PIEZON is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIR-FLOW MASTER PIEZON is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIR-FLOW MASTER PIEZON is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of the base control unit, hoses and connectors for two handpieces, and a foot control containing a four-position switch. There are two mounts on the top of the base unit, one for an irrigation liquid container and the other for one of the two air-polishing chambers supplied with the device.

The AIR-FLOW MASTER PIEZON is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures.

The AIR-FLOW MASTER PIEZON is also supplied with the AIR-FLOW Handpiece and PERIO-FLOW Handpiece for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC (sodium bicarbonate), AIR-FLOW SOFT (glycine), and AIR-FLOW PERIO (glycine) prophylaxis powders.

The AIR-FLOW MASTER PIEZON is supplied with accessories for attaching and removing instruments and nozzles from the handpieces and containers for storage and sterilization of the reusable components and accessories.

Here's an analysis of the provided text regarding the EMS AIR-FLOW MASTER PIEZON, focusing on acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• Operational Characteristics
• Functional Technological Characteristics | Demonstrated through direct comparison and testing of integrated functionalities. The device fulfills prospectively defined design and performance specifications. |

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

The document describes non-clinical performance testing against established standards. These involve engineering and laboratory tests, not tests on a "test set" in the sense of patient data. Therefore, notions of sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this submission. The testing was performed on the device itself and its components.

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

This information is not applicable as the study involved non-clinical performance testing against pre-defined engineering and medical device standards, not clinical diagnostic accuracy or efficacy requiring expert ground truth in the traditional sense. The "ground truth" here is the adherence to the specifications outlined in the standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involved non-clinical performance testing against established standards. There was no "test set" requiring adjudication by clinicians for diagnostic accuracy or outcome.

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 study was conducted. This device is an ultrasonic scaler and air-polishing unit, not an AI software or diagnostic tool that assists human readers.

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

No standalone algorithm performance study was done. This device is a physical dental instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the compliance with recognized international and national consensus standards for medical device safety, electrical safety, electromagnetic compatibility, and sterilization/reprocessing. These standards define objective, measurable criteria for performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical dental instrument, not an AI model requiring a training set.

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

This is not applicable as there was no training set.

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The miniMaster LED is an ultrasonic scaler that is intended for the following:

• Removing supra and subgingival calculus deposits and stains from the teeth
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planning
• Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning, and irrigating root canals
• Preparing approximal cavities
• Cementing inlays and onlays
• Retrograde preparation of root canals

The miniMaster LED is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.

The miniMaster LED is a modification of the miniMaster Ultrasonic Scaler that was the subject of K050710. The overall design of the miniMaster LED is identical to the design of the miniMaster. The introduction of Piezon handpiece LED, materials changes to the peristaltic pump tubing, and design modifications implemented for the miniMaster LED were made to improve the functional performance and ease of use of the ultrasonic scaler. These design changes are listed in Table 1.

The provided text describes the 510(k) summary for the miniMaster LED Ultrasonic Scaler, which is a medical device. The information below is extracted and organized to answer your specific questions.

Acceptance Criteria and Device Performance Study for miniMaster LED Ultrasonic Scaler

The miniMaster LED Ultrasonic Scaler is a modified version of the miniMaster Ultrasonic Scaler (K050710), with enhancements primarily focused on illumination and material changes for improved functional performance and ease of use. The acceptance criteria for this device were met through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data, as no clinical testing was submitted. For the non-clinical tests, the sample size is not explicitly mentioned, but it would typically involve a statistically relevant number of devices or components to demonstrate compliance with the referenced standards. The data provenance is derived from non-clinical laboratory and engineering testing.

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

Not applicable. No clinical testing was performed, and therefore, no expert-established ground truth for a clinical test set was required or reported. The ground truth for the non-clinical tests were the measured values and compliance with the specified engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. As no clinical testing was performed, there was no need for an adjudication method by medical experts. Compliance with non-clinical engineering and safety standards is typically determined through direct measurement and comparison to predefined thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. The miniMaster LED is an ultrasonic scaler, a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

No, a standalone (algorithm-only) performance study was not relevant or performed. This device is a physical, electromechanical tool used by a human operator, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device was engineering standards compliance and objective measurements during non-clinical safety, performance, and sterilization validation tests.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not involve a "training set" in the machine learning sense. The "training" in the context of a medical device refers to the design, development, and iterative testing process, not a data-driven training set.

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

Not applicable. As there is no "training set" in the AI/ML context, there is no ground truth established for it. The performance of the device is assessed against established engineering and safety standards.

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