(307 days)
The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The EM-9000 consists of: (1) a Therapy Unit; and (2) a Control Interface Master. The Therapy Unit consists of the following sub-modules: (a) shock wave generator with therapy head; (b) patient table (c) optional Ultrasound Localization System ("ULS"); and (d) accessories. The Electronics Module is mounted within the EM-9000's Housing. Since all of the assembly parts are collected on the main body of the unit, it is a self-contained unit for providing the lithotripsy application. The Control Interface Master consists of the following sub-modules: Hand Held Remote Control Box, Hand Held Table Control Box and Foot Pedal (Optional) The shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an electromagnetic coil, a membrane, an acoustical lens for focusing and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient. The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit.
Acceptance Criteria and Study for ELITE's EM-9000
The ELITE EM-9000 extracorporeal shock wave lithotripter underwent performance testing and a clinical study to demonstrate its safety and effectiveness. The acceptance criteria were primarily based on comparison to legally marketed predicate devices and adherence to established standards for shock wave lithotripters.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical thresholds in the provided document, but rather are implied through comparison to predicate devices and adherence to standards. The "Performance Data" section states that "In all instances, the EM-9000 met its specifications and functioned as intended." and "The results are found similar to the predicate device characteristics."
| Parameter/Criterion | Acceptance Criteria (Implied) | Reported Device Performance (EM-9000) |
|---|---|---|
| Shock Wave Characteristics | Within range or similar to predicate devices (K040476, K070799, P840008) and in conformance with IEC 61846. | Pressure at focus: 630 bar (between 210-1500 bar of predicates) |
| Peak-positive acoustic pressure (Mpa): 48-62 | ||
| Peak-negative acoustic pressure (Mpa): -5.8 to -7.2 | ||
| Rise time (ns): 116-137 | ||
| Pressure pulse duration (ns): 511-537 | ||
| Maximum focal width (mm) (x-y plane): 7.6-8.1 | ||
| Orthogonal focal width (mm): 7.0-8.7 | ||
| Focal extent Fz (mm): 58-75 | ||
| Focal volume (cm3): 2.00-2.27 | ||
| Distance between focus and target (mm) (z axis): 3.6 | ||
| **Derived focal acoustic pulse energy E+ (-6dB) | ||
| (mJ):** 18.3-32.5 | ||
| Localization Accuracy | Met specifications and functioned as intended. | Met specifications and functioned as intended. |
| Road Testing | Met specifications and functioned as intended. | Met specifications and functioned as intended. |
| Clinical Performance | Safe and effective for fragmentation of urinary stones in kidney and ureter, as compared to predicate devices with similar mechanism of action and shock wave characteristics. | Confirmatory clinical study suggests treatment is safe and effective for fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter). |
| Compliance with Standards | Conformance to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-36, IEC 60601-2-46, IEC 61846. | "Results of performance and compliance testing...indicates conformance to all applicable performance standards." |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (K040476, K070799, P840008). | "Comparative performance testing demonstrated the EM-9000 to be substantially equivalent to the predicate devices." and "Based on the comparison to other devices in technological characteristics and intended use, the EM-9000 is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the "confirmatory clinical study" or other performance tests. It mentions "laboratory and clinical data."
- Test Set Sample Size: Not explicitly stated as a number of patients/cases. The document refers to "clinical performance testing in the form of a confirmatory clinical study."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "confirmatory clinical study" typically implies a prospective design, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The document refers to the data providing "reasonable assurance of the safety and effectiveness" but does not detail how the ground truth regarding stone fragmentation, safety, or effectiveness was adjudicated by experts in the context of the clinical study.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done for the EM-9000. This device is a therapeutic lithotripter, not an imaging or diagnostic AI device that typically requires MRMC studies to assess human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable as the EM-9000 is a physical medical device (lithotripter) that requires a human operator for its therapeutic function, rather than an AI algorithm evaluated for standalone performance. The "performance data" section describes the device's technical characteristics and overall clinical effectiveness, which inherently involves human operation and patient interaction.
7. Type of Ground Truth Used
Based on the nature of the device (a lithotripter to fragment stones), the ground truth for the clinical study would likely be related to:
- Stone fragmentation success: Measured by imaging (e.g., X-ray, ultrasound) to determine residual stone size.
- Stone-free rates: Complete absence of fragments or clinically insignificant fragments.
- Adverse events: Clinical outcomes data related to safety.
The document refers to the clinical study supporting "safety and effectiveness," implying these types of clinical outcomes were used as ground truth. However, the specific methodology (e.g., how "effectiveness" was precisely defined and measured, or how "fragments" were quantified) is not detailed.
8. Sample Size for the Training Set
This information is not applicable as the EM-9000 is a physical medical device, not an AI algorithm that undergoes "training" in the traditional sense with a data set. The development of the device would involve engineering design, bench testing, and optimization, but not AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons 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.”)