(176 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in safety and effectiveness to predicate devices (EMS SWISS LITHOCLAST LITHOTRIPTER (K951531), Wolf 2270, Wolf 2280, Candela LaserTripter) for fragmenting urinary tract calculi. | Clinical data demonstrates that the EMS SWISS LITHOCLAST is substantially equivalent in safety and effectiveness to the predicate devices for treatment of renal stones. |
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.
§ 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.”