(221 days)
To fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The LithoDiamond ULTRA consists of: (1) a Therapy Unit; and (2) a Control Interface Master.
The Therapy Unit consists of the following submodules: (a) shock wave generator with therapy head; (b) movement unit (patient table and X-ray Isocentric C-Arm; (c) X-ray Component; (d) optional Ultrasound Localization System ("ULS") and (e) accessories. The X-ray Component of the Therapy Unit consists of the following modules: (a) X-ray module (monoblock and collimator), where the X-rays are generated; (b) Imaging Module, where the X-ray Image is detected and processed; (c) Electronics Module, containing control modules and power supplies: and (d) one or two high resolution black and white monitors. The X-ray Module and Imaging Module are mounted on a turnable C-Arm. The Electronics Module is mounted within the LithoDiamond ULTRA's Housing.
The Control Interface Master contains: (1) one or two X-ray Monitors; (2) the Control Panel; (3) the Remote Monitoring Connector Box; (4) the Release Buttons for X-ray and Shock Wave Generator; (5) the Foot Switch for the X-ray; and (6) a server PC accommodating the Software.
The LithoDiamond ULTRA is a modification to PCK's cleared Stonelith V5 device (K011106). The principal design changes to the Stonelith V5 lithotripter to form the LithoDiamond ULTRA lithoptriper are as follows: (1) use of interchangeable shock heads to provide electromagnetic and electrohydraulic therapy (in contrast to the existing StoneLith V5 device which delivers only electrohydraulic therapy); (2) replacement of the fixed imaging arm ("U" arm) (used with the Stonelith V5) with an Isocentric C-Arm; (3) changes in the software (used with the Stonelith V5) to accommodate the use of both electrohydraulic and electromagnetic therapy as well as the C-arm; (4) the addition of a motorized shock head; and (5) certain minor changes in the dimensions of the support table.
The LithoDiamond® ULTRA Extracorporeal Shock Wave Lithotripter: Acceptance Criteria and Study Details
Executive Summary
The LithoDiamond ULTRA Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney and ureter. To demonstrate its safety and effectiveness, PCK Electronic Industry and Trade Company, LTD, Inc. conducted performance testing, including Shock Wave Characteristics, Localization Accuracy, Road Testing, and Clinical Performance Testing. The device met all its specifications and functioned as intended. The substantial equivalence claim is based on performance data showing the device is as safe and effective as predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific numerical acceptance criteria. Instead, it broadly states that the device "met its specifications and functioned as intended" across several performance categories. The performance categories and the reported outcome are as follows:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Shock Wave Characteristics | Met its specifications and functioned as intended. |
| Localization Accuracy | Met its specifications and functioned as intended. |
| Road Testing | Met its specifications and functioned as intended. |
| Clinical Performance Testing | Met its specifications and functioned as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for the test set used in the performance studies.
The data provenance is retrospective, as the studies were conducted by PCK Electronic Industry and Trade Company, LTD, Inc., based in Sincan, Ankara, Turkey. The submission was sent to the FDA in the United States for regulatory review.
3. Number of Experts and their Qualifications for Ground Truth
The 510(k) summary does not provide information regarding the number of experts used to establish ground truth or their specific qualifications.
4. Adjudication Method
The 510(k) summary does not provide information regarding the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed or any effect size for human readers with and without AI assistance. The device in question is a lithotripter, not an AI diagnostic tool, so such a study would not be expected.
6. Standalone (Algorithm Only) Performance
A standalone performance study for the algorithm was not explicitly performed or described in the context of an "algorithm only without human-in-the-loop performance." The device is a physical medical device (lithotripter) with integrated software, and its performance is assessed as a complete system rather than evaluating an isolated algorithm. The "Performance Data" section describes testing of the overall device's characteristics and clinical performance.
7. Type of Ground Truth Used
The type of ground truth used is implied to be clinical outcomes data from the "Clinical Performance Testing" and measurements against technical specifications for "Shock Wave Characteristics," "Localization Accuracy," and "Road Testing." The exact nature or source of this clinical data (e.g., patient outcomes, stone fragmentation success rates, absence of complications) is not detailed.
8. Sample Size for the Training Set
The 510(k) summary does not specify the sample size for any training set. Given that this is a physical medical device and not a machine learning model in the modern sense of requiring extensive training data, a distinct "training set" for an AI algorithm is not explicitly mentioned as being part of the submission criteria for this type of device in 2006. The software changes mentioned (to accommodate new hardware) imply software development and testing, but not necessarily a "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" in the context of machine learning is mentioned, no information is provided on how ground truth for such a set was established. Ground truth for the underlying device's development (its "training") would typically come from engineering specifications, industry standards, and preclinical testing results.
§ 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.”)