(21 days)
The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.
The Multipurpose Probe is a rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece of the target to the stone. A lateral notch in the distal end of the probe allows for fixation of mobile ureteral stones, thus reducing the risk of stone push back in the ureter. The probe can be reused five times and may be sterilized by steam sterilization according to standard hospital procedures.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. This document is a 510(k) summary for a medical device (Swiss LITHOCLAST® Multipurpose Probe), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific statistical metrics.
However, based on the available information, I can extract and infer the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Probe Longevity | Expected to be at least as good as the predicate device (EMS 1.0 mm Probe). | Testing was performed to support substantial equivalence. (Specific cycles/durability not quantified in this summary) |
| Probe Tip Velocity | Expected to be within acceptable ranges for stone fragmentation, comparable to the predicate device. | Testing was performed to support substantial equivalence. (Specific velocity ranges not quantified in this summary) |
| Probe Tip Displacement | Expected to be within acceptable ranges for stone fragmentation, comparable to the predicate device. | Testing was performed to support substantial equivalence. (Specific displacement ranges not quantified in this summary) |
| Clinical Performance | Effective fragmentation of ureteral calculi through rigid or semi-rigid endoscopes, with potential benefit of reduced stone push-back. | Clinical use assessment was performed, suggesting equivalence and the benefit of the lateral notch for stone fixation. |
| Sterilization | Ability to be sterilized by steam sterilization according to standard hospital procedures. | The probe "may be sterilized by steam sterilization according to standard hospital procedures." |
| Material | Device constructed from specified surgical grade material. | Made of "rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod." |
Note: The acceptance criteria are largely inferred based on what would typically be evaluated for substantial equivalence in medical device submissions, as specific quantitative criteria are not explicitly stated in this summary.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "clinical use assessment" but does not provide details on the number of patients or cases included in this assessment.
- Data Provenance: Not specified. It's likely that the testing (longevity, velocity, displacement, clinical use assessment) was conducted by the manufacturer (ELECTRO MEDICAL SYSTEMS SA) in Switzerland, but this is not explicitly stated. It is presented as an assessment to support substantial equivalence, not a formal clinical trial with geographic details. The type of data (retrospective or prospective) is also not stated.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the given text. The "clinical use assessment" and "basis for substantial equivalence" do not specify the involvement of experts in establishing a ground truth for a test set in the way a typical clinical study would. The summary focuses on comparing the new device to a predicate device through technical and basic clinical assessments, not on establishing a "ground truth" via expert consensus for a diagnostic task.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. There is no mention of a formal adjudication process for a test set, as this is not a study involving expert readers interpreting results against a consensus ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided summary. The submission focuses on demonstrating substantial equivalence through technical testing and a general "clinical use assessment," not a comparative study of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a mechanical lithotripter probe, not an algorithm or AI-powered system, so a standalone algorithm performance study would not be relevant.
7. Type of Ground Truth Used
- The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data, expert consensus on images) is not directly applicable to this device submission.
- Instead, the "truth" for this submission revolves around the performance characteristics of the probe (longevity, tip velocity, displacement) and its ability to fragment stones in a clinical setting, as compared to a predicate device.
- The "clinical use assessment" would have likely relied on clinical observations/outcomes (e.g., successful stone fragmentation, absence of complications) rather than a defined ground truth like pathology reports.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical instrument, not an AI or algorithmic system trained on data, so there is no training set in the conventional sense.
9. How Ground Truth for Training Set was Established
- Not applicable. As a physical medical device, there is no training set or ground truth in the context of machine learning.
§ 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.”