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510(k) Data Aggregation
(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.
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(29 days)
The UroVantage is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to Urologic and endoscopic procedures. The device may be used for other imaging applications at physician's discretion.
The UroVantage is an Image-Intensified Fluoroscopic X-Ray System and radiological table. The device consists of: a tilting patient support table; x-ray generator; control panel; remote control panel, x-ray tube assembly, collimator, image intensifier, television ("TV") system with monitor; tableside control. The Isocentric C-arm of the UroVantage ensures easy control and issues intensifier and x-ray tube around the patient. The device s movement of x-ray stand with a tilting table also provides support for both the thou modition is as a m. Standard and optional accessories also are supplied.
The UroVantage is a modification to PCK's UROlogic device that has already been The Orovide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures (K011311). The during diagnootic, barger intended use and fundamental scientific technology as the Orovantage nas the battle interations are: (1) replacement of the fixed imaging arm ("U" arm) with an Isocentric C-Arm; (2) the fixation of the Isocentric C-arm to the support table; (3) minor changes in the dimensions of the support table; and (4) changes in the software to accommodate the use of the Isocentric C-arm.
This 510(k) summary for the UroVantage Urological Table does not contain information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The document focuses on demonstrating substantial equivalence to a predicate device (UROlogic, K011311) based on:
- Same intended use and indications for use.
- Similar technological characteristics and principles of operation.
- Minor differences that do not raise new questions of safety or efficacy.
Therefore, I cannot provide the requested information. The submission describes a device modification, relying on the predicate's established safety and effectiveness rather than presenting new performance data for the UroVantage itself.
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(306 days)
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(71 days)
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic applications The system may be used for other imaging applications at physician's discretion.
UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imaging of patient with an undertable image intensifier. The system consists of a floor mounted tilting patient support table, x-ray generator, xsystem or a sembly, image intensifer and the tv system. The system is operated via tableside control panel, foot/handswitches and x-ray control panel. The system comes with a tripple mode image intensifier, a CCD camera with one frame memory, x-ray tube with housing and an image monitor. The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.
This 510(k) submission pertains to the UROlogic Urological Table, an image-intensified fluoroscopic x-ray system. The document provided does not contain specific acceptance criteria, device performance data, details of a clinical study, or information about AI integration.
The submission focuses entirely on demonstrating substantial equivalence to predicate devices (OEC Uroview 2600 and Liebel-Flarsheim Hydradjust IV) based on technological characteristics and intended use. The FDA letter confirms this substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics as these are not present in the provided text.
Based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
- This information is not provided in the given 510(k) summary. The submission focuses on substantial equivalence based on the device's technical specifications and intended use, rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
- This information is not provided. No clinical study data is presented in the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. No clinical study data is presented, and therefore no ground truth establishment for a test set is discussed.
4. Adjudication method for the test set:
- This information is not provided. No clinical study data is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not provided. The device described is an X-ray table, and the submission makes no mention of AI or software for image interpretation, or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not provided. No AI algorithm is mentioned or evaluated.
7. The type of ground truth used:
- This information is not provided. No clinical study data is presented requiring ground truth.
8. The sample size for the training set:
- This information is not provided. No AI training is mentioned.
9. How the ground truth for the training set was established:
- This information is not provided. No AI training is mentioned.
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