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The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder.

The EMS Swiss LithoClast® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone; (2) ultrasound lithotripsy alone; (3) and combined pneumatic and ultrasound lithotripsy. The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch. The pneumatic unit of the system is essentially the same as the Swiss LithoClast® Operation of this unit requires a supply of medical quality compressed air from either a compressor or a central hospital supply. The compressed air provides the pressure a compresses ve a be projectile within the Swiss LithoClast® handpiece toward the proximal end of the probe. The pressure pulse propagates to the distal tip of the probe and is transferred to the stone, resulting in fragmentation. The pneumatic unit prood and in combination with the Swiss LithoVac® for suction of stone fragments. The LithoClast® probes can be inserted through the LithoVac® probes for simultaneous lithotripsy and suction. The ultrasound handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating at approximately 24 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and probes are hollow, permitting simultaneous suction. Two probe sizes are available: 3.3 mm and 3.8 mm. Combined operation of the pneumatic and ultrasound units is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasound handpieces must be mounted together to form a LithoClast® Master handpiece using an adjustment interface. The 1 mm pneumatic probe is inserted through the adjustment interface and through either the 3.3 mm or 3.8 mm ultrasound probe. The probes must be length-adjusted by turning the nut of the adjustment interface so that the tip of the pneumatic probe is flush with the tip of the ultrasound probe.

The provided text describes a 510(k) submission for the Electro Medical Systems SA SWISS LITHOCLAST® MASTER. It is a premarket notification to establish substantial equivalence to a legally marketed predicate device, not a study designed to prove the device meets specific performance acceptance criteria in the way a clinical trial or a novel AI device study would.

Therefore, many of the requested categories are not directly applicable or explicitly detailed in this type of regulatory document. The focus of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to set new performance benchmarks with explicit acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred:

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

This document does not specify formal, quantitative acceptance criteria for device performance as would be found in a study for a novel device. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported is in relation to this goal.

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 mentions "stone fragmentation testing" on "a variety of standard artificial stone materials."

• Sample Size for Test Set: Not explicitly stated. It refers to "a variety of standard artificial stone materials," implying multiple types of stones were tested, but the number of tests or specific sample sizes are not provided.
• Data Provenance: Not explicitly stated. The testing was likely conducted by the manufacturer, Electro Medical Systems SA, located in Nyon, Switzerland. This would imply an in vitro laboratory test rather than a clinical study with patient data. As such, it's not "retrospective or prospective" in the clinical sense.

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

Not applicable. The "stone fragmentation testing" likely involves objective physical measurements (e.g., time to fragmentation, fragment size analysis) in a laboratory setting, not expert clinical assessment of "ground truth."

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

Not applicable. This concept applies to human expert review of clinical cases. The stone fragmentation testing would involve laboratory protocols and measurement.

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

Not applicable. This is not an AI device or a diagnostic imaging device that would typically involve human readers.

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

Not applicable. This is a medical device for intervention (lithotripsy), not an algorithm or AI. The performance discussed is the device's physical ability to fragment stones.

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

The "ground truth" for the stone fragmentation testing would be defined by objective physical measurements of stone fragmentation parameters (e.g., time to fragment, fragment morphology, completeness of fragmentation) against a "standard" or established performance benchmark for predicate devices. It is based on in vitro laboratory measurements rather than expert clinical judgment or pathology.

8. The sample size for the training set

Not applicable. This is not an AI device. The device's design and operation are based on established pneumatic and ultrasonic lithotripsy principles, refined from previous versions.

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

Not applicable. As this is not an AI/ML device, there isn't a "training set" in that context. The "ground truth" for its development would be based on engineering principles, clinical experience with previous generations of the device (Swiss LithoClast®), and a scientific understanding of lithotripsy mechanisms, rather than a data-driven training set.

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The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney.

MASTER Handpiece: The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.

3.2 mm Probe: The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.

The provided text describes a 510(k) summary for the ELECTRO MEDICAL SYSTEMS SA LITHOCLAST® MASTER Handpiece and 3.2 mm Probe, seeking clearance based on substantial equivalence to predicate devices. The submission details various tests performed to support this claim for both the handpiece and the probe.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it describes various tests performed to demonstrate substantial equivalence to existing predicate devices. The implication is that the performance of the new device (MASTER Handpiece and 3.2 mm Probe) was considered acceptable if it performed comparably to, or improved upon, the predicate devices in the specific tests mentioned.

Here's an interpretation of the performance and implied criteria based on the text:

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 sample sizes for any of the tests performed (lifetime, displacement, velocity, impact pressure, disintegration efficiency, in-vitro tissue impact studies).

The data provenance (country of origin, retrospective/prospective) is also not mentioned in this summary. It's likely these were in-house laboratory tests conducted by ELECTRO MEDICAL SYSTEMS SA, which is based in Nyon, Switzerland.

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 section is not applicable to this submission. The tests described are bench or in-vitro performance studies, not clinical studies involving expert interpretation of patient data to establish ground truth.

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

This section is not applicable. No human interpretation or adjudication of results is mentioned for these performance tests.

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

There is no MRMC study mentioned, as this is a device for fragmenting kidney stones, not an AI-assisted diagnostic tool where human readers would be involved.

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

This is not applicable in the context of an AI algorithm. The device itself (handpiece and probe) is the standalone entity, and its performance was evaluated in various bench and in-vitro tests without human assistance during the actual fragmentation process, although a surgeon would operate it.

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

For the performance tests mentioned, the "ground truth" would be established by:

• Measurement of physical parameters: For "lifetime," "probe displacement," "probe velocity," and "impact pressure," the ground truth would be directly measured physical quantities using appropriate sensors and equipment.
• Quantitative results of efficacy: For "disintegration efficiency," the ground truth would be objectively measurable outcomes like the extent of stone fragmentation or reduction in stone mass.
• Observable effects: For "in-vitro tissue impact studies," the ground truth would involve observable or measurable effects on the tissue, often compared against a control or predicate device's effects.

8. The sample size for the training set

This is not applicable. This is a hardware medical device clearance, not an AI/machine learning application requiring a training set.

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

This is not applicable for the same reason as above.

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The EMS SwISS LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.

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Here's an analysis of the provided text regarding the acceptance criteria and study for the EMS SWISS LITHOCLAST LITHOTRIPTER, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K963285 does not explicitly state numerical acceptance criteria (e.g., minimum success rate, stone-free rate, or complication rate thresholds). Instead, the reported device performance is framed in terms of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly tied to the safety and effectiveness profiles of the cited predicate devices as reported in medical literature.

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

• Sample Size: 83 kidneys
• Data Provenance:
  • Country of Origin: Not explicitly stated. The sponsor is Swiss (Electro Medical Systems SA, Switzerland), and the clinical study was conducted at "two investigational sites," but their locations are not provided.
  • Retrospective/Prospective: Retrospective clinical study.

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

This information is not provided in the given text. The study is described as a "clinical study of the results," suggesting that the outcomes were assessed by the clinicians at the investigational sites, but no details on their number or specific qualifications for establishing ground truth are given.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

There is no indication of an MRMC study. This device is a medical instrument (lithotripter), not an AI-powered diagnostic or interpretive tool that would typically involve "human readers" or "AI assistance" in the way an MRMC study evaluates.

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

This refers to a standalone clinical study of the device's performance without the explicit comparison to human interpretation or AI.

• Yes, a standalone clinical study was done. The "retrospective clinical study of the results on 83 kidneys" represents the standalone performance evaluation of the EMS SWISS LITHOCLAST.

7. The Type of Ground Truth Used

The ground truth implicitly relates to the clinical outcomes of stone fragmentation and clearance, as assessed by the clinicians treating the patients. This would fall under outcomes data or clinical assessment of treatment success and safety. The text uses terms like "results," "safety," and "effectiveness," which are direct clinical outcome measures.

8. The Sample Size for the Training Set

This information is not applicable / not provided. This is a medical device, not an AI/machine learning model that typically requires a distinct "training set" in the computational sense. The "clinical study" evaluates the device's performance, not the training of an algorithm.

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

This information is not applicable / not provided for the same reason as point 8. The concept of a "training set" and its "ground truth establishment" is not relevant to the evaluation of this type of medical device in the context described.

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