(23 days)
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.
| Acceptance Criteria (Inferred for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The device has the same intended use as predicate devices. | The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder, which is stated to be the same as predicate devices. The pneumatic module was previously cleared for kidney, ureter, and bladder stones. |
| Technical Specifications Equivalence: The device has similar technical specifications as predicate devices. | The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® (K951531, K963285). The pneumatic unit is essentially the same. The ultrasound module is substantially equivalent to predicate ultrasonic lithotripters (e.g., Storz Ultrasound Lithotripters, Richard Wolf Ultrasound Generator). |
| Performance Equivalence (Fragmentation): The device demonstrates equivalent or superior stone fragmentation compared to predicate devices. | Stone fragmentation testing confirmed that the Swiss LithoClast® Master results in equivalent or faster fragmentation of a variety of standard artificial stone materials (ranging from soft to hard) when tested against various predicate ultrasound lithotripters. |
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.
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”