(29 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 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 basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.
The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.
This document describes a 510(k) submission for the Delta III Lithotripter, which is a modification to a previously cleared device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies to establish absolute performance against defined acceptance criteria for a novel device.
Therefore, the typical structure for reporting acceptance criteria and study details for a new device's performance may not be fully applicable here. However, I can extract the information provided regarding the changes and how their safety and effectiveness were addressed.
Here's an analysis based on the provided text, addressing the points you requested where relevant:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., stone free rate, re-treatment rate) for the modified device, as this is a modification to a predicate device. The primary performance demonstration is focused on showing that the changes do not negatively impact safety or effectiveness.
| Acceptance Criteria (Implied for changes) | Reported Device Performance |
|---|---|
| Electrical safety compliance | Device is in compliance with IEC 60601-1:2005. |
| Electromagnetic compatibility compliance | Device is in compliance with IEC 60601-1-2:2007. |
| Radiation protection compliance | Device is in compliance with IEC 60601-1-3: 2008 and IEC 60601-2-54. |
| Safety of equipment for extracorporeally induced lithotripsy compliance | Device is in compliance with IEC 60601-2-36: 1997. |
| Ultrasonics characteristics of fields compliance | Device is in compliance with IEC 61846. |
| Usability compliance | Device is in compliance with IEC 62366:2007. |
| Software functionality (wheel performance, collision protection) | Appropriate software verification testing was performed. |
| Hand controller function | Verification of hand controller function testing was performed. |
| Ultrasound localization accuracy (with additional ultrasound units) | Engineering analysis concluded prior ultrasound localization accuracy testing supported compatibility. |
| No new unanticipated risks | No unanticipated new risks identified. |
| Maintains intended use, technological characteristics, and principles of operation of predicate | The modified Delta III has the same intended use, technological characteristics, and principles of operation as the predicate device. Minor differences do not alter intended use or affect safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes tests for compliance with electrical, EMC, radiation, and usability standards, as well as software and hardware verification. These are typically engineering and bench tests, not clinical studies with human subjects in the traditional sense. Therefore, the concept of "sample size used for the test set" for patient data, country of origin, or retrospective/prospective does not apply to the provided performance data. The tests performed are on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The performance data provided is based on compliance with international standards and internal engineering verification, not on expert adjudication of clinical outcomes or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable, as the tests are for engineering compliance and verification, not for clinical outcomes requiring expert adjudication.
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 section is not applicable. The device is a lithotripter, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device (lithotripter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the verification tests mentioned (e.g., electrical safety, software functionality), the "ground truth" is defined by the requirements of the applicable international standards (e.g., IEC 60601 series) and the design specifications of the device. For example, for electrical safety, the ground truth is compliance with the specified voltage limits or isolation requirements in the standard. For software, it's meeting the intended function and not introducing errors.
8. The sample size for the training set
This section is not applicable. The document describes a physical medical device and its modifications, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.”)