(298 days)
LITHOSKOP is a urologic procedures system primarily designed for the fragmentation of urinary tract stones, such as renal calyx stones and renal pelvis stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
Siemens LITHOSKOP is a new lithotripter featuring a patient table, a C-arm 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 a 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 use.
The presented document is a 510(k) summary for the Siemens LITHOSKOP, an extracorporeal shockwave lithotripter. It provides information about the device's indications for use, contraindications, warnings, precautions, adverse events, and technological characteristics. It also states that a confirmatory clinical study was conducted to demonstrate the device's safety and effectiveness. However, the document does not explicitly define acceptance criteria in a quantifiable manner or present detailed performance data from the clinical study in the format requested.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Based on the provided text, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "The confirmatory clinical study suggests that treatment of urinary tract stones with the LITHOSKOP is safe and effective." However, specific numerical acceptance criteria (e.g., stone-free rate, retreatment rate) and detailed performance metrics are not provided in this summary.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Inferred/General) |
|---|---|
| Safety acceptable | Confirmatory clinical study suggests safe |
| Effectiveness acceptable | Confirmatory clinical study suggests effective |
2. Sample Size and Data Provenance
- Sample Size (Test Set): Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary (e.g., country of origin, retrospective/prospective). The study is referred to as a "confirmatory clinical study," which generally implies a prospective design.
3. Number and Qualifications of Experts for Ground Truth
Not specified in the provided summary.
4. Adjudication Method
Not specified in the provided summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this device is a medical lithotripter, not an imaging analysis AI tool that assists human readers. No mention of an MRMC study or human reader improvement with AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable, as this is a physical medical device (lithotripter), not a standalone algorithm.
7. Type of Ground Truth Used
The "confirmatory clinical study" would likely use clinical outcomes (e.g., stone fragmentation, stone-free status, need for retreatment, adverse events) as ground truth. The summary mentions monitoring for hematuria, pain, urinary obstruction, etc., as adverse events.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model that requires a training set in the conventional sense. The "confirmatory clinical study" is likely a pivotal trial for regulatory submission.
9. How Ground Truth for the Training Set Was Established
Not applicable (as above).
§ 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.”)