(223 days)
MODULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS.
The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment.
Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head Colus, a patient table, and an ECG device.
One configuration would include a mobile C-arm to provide the imaging and positioning of the shockwave focus to the urinary tract stones. This configuration may be used to treat renal calyceal stones, renal pelvis stones, and ureteral stones.
A second configuration would include an ultrasound system to provide the imaging and positioning of the shockwave focus to the urinary tract stones. For this configuration, the indication for use is limited to the fragmentation of kidney and upper ureteral stones only.
Siemens MODULARIS Variostar is a modified lithotripter featuring a patient table, a Carm with X-ray tube assembly attached to one end, an image intensifier to the other end and a shockwave system adjacent to the x-ray tube. The shockwave system can be coupled with the patient in various positions providing a high flexibility. For positioning of the shockwave focus there will be fluoroscopy and ultrasound imaging provided. The system is intended for stationary and trans-mobile use.
Here's an analysis of the provided text to fulfill your request:
Based on the provided 510(k) summary for the MODULARIS Variostar, the information regarding acceptance criteria and the study proving the device meets them is limited and does not include many of the specific details you requested. This is common for 510(k) submissions, which often focus on demonstrating substantial equivalence to a predicate device rather than extensive de novo clinical trials with detailed statistical analyses for performance metrics.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria for a clinical study. Instead, it mentions that the confirmatory clinical study suggests the treatment is "safe and effective." Without specific metrics (e.g., stone-free rate percentage, fragmentation rate, retreatment rate), a table cannot be constructed with detailed performance values.
However, based on the nature of a lithotripter, implied performance would be related to the successful fragmentation and elimination of urinary tract stones. Since the device is cleared as "substantially equivalent" to the LITHOSTAR Modularis, its performance is implicitly considered acceptable if it is comparable to that predicate device.
Absence of Specific Quantitative Acceptance Criteria and Performance Data:
The 510(k) summary does not disclose quantitative acceptance criteria (e.g., "stone-free rate must be > X%") or specific reported device performance metrics in numerical form (e.g., "stone-free rate was Y%"). The statement "The confirmatory clinical study suggests that treatment of urinary tract stones with the MODULARIS Variostar is safe and effective" is a qualitative conclusion rather than a quantitative performance metric.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "the confirmatory clinical study" but does not provide its sample size.
- Data Provenance (Country, Retrospective/Prospective): Not explicitly stated. The document does not specify the country of origin for the clinical data or whether it was a retrospective or prospective study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method (Test Set)
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not mentioned. The document focuses on the lithotripter's therapeutic efficacy rather than diagnostic imaging or interpretation of images by multiple readers. Therefore, an MRMC study is highly unlikely to have been performed for this type of device.
- Effect Size of Human Readers with/without AI: N/A. AI assistance for human readers is not discussed in the context of this lithotripter.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? N/A. This device is a medical apparatus (lithotripter), not an AI algorithm. Its performance is inherent to its physical operation and effect on stones, not an independent algorithm's output.
7. Type of Ground Truth Used
- Type of Ground Truth: The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus on images) doesn't directly apply here. For a treatment device like a lithotripter, the "ground truth" for effectiveness would be clinical outcomes data, such as stone-free status confirmed by imaging, absence of complications, need for retreatment, etc. The summary implies that the clinical study assessed safety and effectiveness, which would derive from such outcomes. Specific methods for outcome assessment (e.g., post-treatment imaging protocols) are not detailed.
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A. This device is a physical lithotripter, not a machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- How Ground Truth was Established: N/A. This device is a physical lithotripter, not a machine learning algorithm that requires a training set.
Additional Relevant Information from the Document:
- Regulatory Pathway: 510(k) premarket notification, demonstrating "substantial equivalence" to the LITHOSTAR Modularis. This pathway typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often without requiring extensive new clinical trials if technological differences are minor and well-understood.
- Non-Clinical Performance Data: "Device shockwave parameters were measured and documented according to Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shockwave Lithotripters in K033337. MODULARIS Variostar features the same shockwave head and generator as the predicate device LITHOSTAR Modularis." This indicates that the non-clinical performance was confirmed by comparing physical properties and shockwave characteristics to established standards and those of the predicate device.
- Clinical Performance Data: "The confirmatory clinical study suggests that treatment of urinary tract stones with the MODULARIS Variostar is safe and effective." This is a general statement as discussed above.
In summary, the provided 510(k) focuses on demonstrating substantial equivalence primarily through technological characteristics and adherence to existing guidance. While a "confirmatory clinical study" is mentioned, the specific details regarding its design, sample size, metrics, and ground truth establishment are not disclosed in this summary.
§ 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.”)