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510(k) Data Aggregation
(57 days)
The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of bladder calculi.
These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of bladder 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.
This document describes the 510(k) submission for the Karl Storz Calcusplit Pneumatic Lithotriptor. The device is a pneumatic lithotriptor designed for the fragmentation of bladder calculi.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., fragmentation time, stone clearance rate). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety no worse than predicate (EMS Swiss Lithoclast) | Bench testing of probe endurance and tissue effects demonstrated safety no worse than the EMS Swiss Lithoclast. |
| Effectiveness no worse than predicate (EMS Swiss Lithoclast) | Bench testing of probe endurance and tissue effects demonstrated effectiveness no worse than the EMS Swiss Lithoclast. |
| Same intended use as predicate | The Calcusplit has the same intended use as the predicate Swiss Lithoclast (pneumatic fragmentation of bladder calculi). |
| Same technological characteristics as predicate | Both the Calcusplit and the Lithoclast systems use compressed air and direct contact, rigid probes to fragment urinary tract stones under direct vision endoscopic control. |
2. Sample size used for the test set and the data provenance:
The document mentions "Bench testing of probe endurance and tissue effects." It does not specify the sample size for this bench testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information is provided regarding experts or ground truth establishment for a test set. The evaluation relies on direct comparison to the predicate device's established safety and effectiveness.
4. Adjudication method for the test set:
Not applicable. There is no mention of a test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The evaluation method described is bench testing and comparison to a predicate device, not a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a pneumatic lithotriptor, not an AI algorithm. Its performance is inherent to its mechanical function.
7. The type of ground truth used:
The "ground truth" for the device's performance is established by the safety and effectiveness of the legally marketed predicate device (EMS Swiss Lithoclast Lithotriptor). The Karl Storz Calcusplit's performance is deemed acceptable if it is "no worse than" the predicate. A literature search also supported the general safety and effectiveness of Pneumatic Lithotripsy.
8. The sample size for the training set:
Not applicable. This device is a mechanical medical instrument, not an AI system that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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(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.
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