(297 days)
These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.
Not Found
The Karl Storz Calcuson Ultrasonic Lithotriptor is intended for the fragmentation of renal, ureteral, and bladder calculi.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for the Calcuson Ultrasonic Lithotriptor in terms of specific performance metrics (e.g., fragmentation rate, stone clearance rate, or power output). The 510(k) submission process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than defining new performance benchmarks for a novel device.
However, the "Indications for Use" section implicitly sets the functional acceptance criterion: The device must be capable of fragmenting renal, ureteral, and bladder calculi.
The reported device performance, based on the FDA's clearance, is that it is "substantially equivalent" to legally marketed devices for the stated indications. This implies that the device is expected to perform comparably to existing ultrasonic lithotriptors in terms of its ability to fragment the specified types of calculi. Without a detailed study report, specific numerical performance data for the Calcuson itself is not provided in this regulatory document.
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) clearance letter and associated documents do not include information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission where, if a study was conducted, it would primarily focus on demonstrating substantial equivalence, often through bench testing, animal studies, or comparison to existing clinical data of the predicate device, rather than a full-scale clinical trial to establish novel performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. As mentioned, a formal clinical study with ground truth established by experts is not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there is no specific test set or clinical study described within the provided regulatory information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size related to human reader improvement with or without AI assistance. This device is an ultrasonic lithotriptor, a surgical tool, and not a diagnostic imaging device that would typically involve human "readers" or AI assistance in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The Karl Storz Calcuson is a surgical instrument operated by a qualified surgeon, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is irrelevant.
7. Type of Ground Truth Used:
Given the nature of the device and the provided document, the "ground truth" for the 510(k) submission would likely be established through:
- Bench testing: Demonstrating the ability to fragment various types of calculi in a controlled environment.
- Performance specifications: Meeting engineering and design specifications for power output, frequency, and other physical characteristics suitable for lithotripsy.
- Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate device(s).
No direct clinical "ground truth" in the form of pathology, expert consensus on images, or outcomes data from a de novo clinical trial is described in this regulatory filing.
8. Sample Size for the Training Set:
Not applicable. This is a medical device, an ultrasonic lithotriptor, not an AI/ML algorithm 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 an AI/ML algorithm.
§ 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.”