(166 days)
The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III Lithotripter is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk Image Processing.
The provided document is a 510(k) summary for the Dornier Delta III Lithotripter, detailing its substantial equivalence to predicate devices. It mentions a retrospective confirmatory clinical study, but it does not provide specific acceptance criteria or the study's detailed results in a format that allows for a table of acceptance criteria vs. device performance.
Here's an analysis of the information available and what is not present in the document, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "A retrospective confirmatory clinical study was performed using the Delta III Lithotripter. As compared to the currently cleared Dornier Lithotripters, the overall treatment results were comparable for the subject device. The complication rate was extremely low."
However, specific numerical acceptance criteria (e.g., stone-free rate, fragmentation rate, complication rate thresholds) and precise reported device performance metrics against those criteria are not provided in this 510(k) summary. The summary only gives a qualitative statement of comparability and low complication rates.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the retrospective confirmatory clinical study. It is stated to be a "retrospective confirmatory clinical study." The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The type of ground truth used (e.g., imaging, clinical outcomes) is also not detailed for the clinical study.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The clinical study described is a "retrospective confirmatory clinical study" to compare overall treatment results and complication rates, not specifically to evaluate human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The device is an extracorporeal shock wave lithotripter, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable and not mentioned. The performance data section refers to compliance with standards for acoustic output, electrical safety, and electromagnetic compatibility for the hardware device itself.
7. Type of Ground Truth Used
For the retrospective clinical study, the document broadly refers to "overall treatment results" and "complication rate." It does not explicitly state the method by which ground truth for treatment success or stone fragmentation was established (e.g., follow-up imaging, clinical assessment, pathology).
8. Sample Size for the Training Set
The Delta III Lithotripter is a hardware device for lithotripsy, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, this concept is not applicable and not provided. The device development involved design and verification testing, and compliance with standards.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" for an AI algorithm is not applicable to this device.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)