(73 days)
The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of renal and lower ureteral calculi.
These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of lower ureter and renal calculi.
The Karl Storz Calcusplit is a pneumatic lithotriptor designed for the pneumatic fragmentation of urinary calculi. The Calcusplit system uses pneumatic energy converted to mechanical energy to disintegrate calculi. The force of the mechanical energy provided by this device is sufficient to fragment calculi of most sizes and composition.
The provided text is a 510(k) summary for the Karl Storz Calcusplit Pneumatic Lithotriptor. This document focuses on demonstrating substantial equivalence to a predicate device (EMS Swiss Lithoclast) rather than establishing novel safety and effectiveness criteria as would be done for a new device. Therefore, the information provided is not structured in a way that directly addresses typical "acceptance criteria" for a new AI/medical imaging device and the study proving it meets those.
However, I will extract the relevant information and interpret it within the given framework, noting where the information is not directly applicable or is inferred.
Here's an analysis based on your request, with the understanding that this document describes a device substantially equivalent to another device and not a novel AI/imaging device with specific performance metrics against a defined acceptance criterion.
Acceptance Criteria and Device Performance for Karl Storz Calcusplit Pneumatic Lithotriptor
The document describes a comparative study against a predicate device, not a study setting de novo acceptance criteria. The "acceptance criteria" here are effectively "no worse than the predicate device" in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from Clinical Trial and Bench Testing) |
|---|---|
| Safety: No worse than the EMS Swiss Lithoclast Lithotriptor regarding tissue effects and overall safety. | Bench testing demonstrated that safety was "no worse than" the predicate. Clinical trial demonstrated safety was "no worse than" the predicate. |
| Effectiveness: No worse than the EMS Swiss Lithoclast Lithotriptor in the pneumatic fragmentation of renal and lower ureteral calculi. | Bench testing demonstrated that effectiveness was "no worse than" the predicate (e.g., probe endurance). Clinical trial demonstrated effectiveness in fragmenting lower ureter and renal stones was "no worse than" the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "an unmasked and self-controlled multi-center clinical trial." However, it does not specify the sample size for this clinical trial.
- Data Provenance: The document does not explicitly state the country of origin. It does mention "multi-center," implying data from multiple sites, likely within the country where the FDA submission was made (USA), but this is not confirmed. The trial was prospective, as described by "clinical trial was also conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable in this context. The study is a clinical trial evaluating the performance of a physical medical device (a lithotriptor) in fragmenting stones in human patients. The "ground truth" of whether a stone was fragmented, and the safety outcomes, would be determined by clinical observation, imaging studies, and patient outcomes, likely assessed by the surgeons performing the procedures and other clinical staff, rather than a panel of independent experts establishing a "ground truth" for a test set in the way it's done for AI models (e.g., image annotation).
4. Adjudication Method for the Test Set
Not applicable in the typical sense for an AI/imaging device evaluating a test set. Clinical trial outcomes (e.g., successful stone fragmentation, adverse events) were likely assessed by investigators at each site according to the study protocol. The phrase "unmasked and self-controlled" refers to the trial design, not an adjudication method for a test set of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Readers with vs. without AI Assistance)
Not applicable. This is not an AI or imaging device where human readers interact with AI. It is a pneumatic lithotriptor used by surgeons.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a physical surgical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this clinical trial would be based on clinical outcomes (e.g., successful fragmentation of calculi, complete clearance, residual fragments, complications) as assessed by the treating surgeons and subsequent evaluations (e.g., post-procedure imaging, patient follow-up). The specific methodology for determining successful fragmentation or safety outcomes would have been detailed in the clinical trial protocol (which is not provided here).
8. Sample Size for the Training Set
Not applicable. This device is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.”