(110 days)
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.
§ 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.”