(88 days)
Fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means. The Shock Wave Generator can be operated in 4 modes: a) Bottom Reflector only. b) Top reflector only. c) Alternate mode (asynchronous). d) Simultaneous mode (synchronous).
Here's an analysis of the provided text regarding the device's acceptance criteria and study, structured to answer your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantifiable acceptance criteria such as "fragmentation rate of X% for stones of Y size" or "success rate of Z%". Instead, it relies on regulatory compliance and the device being a "minor modification" with "same fundamental scientific technology and intended use" as predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Meets IEC and UL standards (e.g., IEC 60601-1, UL 2601-1, etc.) |
| Effectiveness | "does not reduce safety and effectiveness" compared to predicate device |
| Technological Equivalence | "same fundamental scientific technology and intended use as predicate devices" |
| Intended Use | Indicated for "Fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states: "No clinical tests were performed." Therefore, there is no test set in the traditional sense of a clinical study involving human subjects or patient data.
- Data Provenance: Not applicable, as no clinical tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable, as no clinical tests were performed and thus no ground truth derived from expert review of patient data.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical tests were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "No clinical tests were performed."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done
- This question is not applicable to this device. The "Duet" is an Extracorporeal Shock Wave Lithotripter (ESWL), which is a physical medical device, not an AI algorithm or software. Its performance is related to mechanical and acoustic properties, not software-based analysis.
7. The Type of Ground Truth Used
- Not applicable in the context of clinical or AI-based performance. The "ground truth" for this submission appears to be compliance with engineering and electrical safety standards (as listed in Section 7 - Performance Testing) and the established safety and effectiveness profile of its predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is a physical medical device and not an AI algorithm.
Summary of the Device Submission's Approach:
This 510(k) submission for the Direx Systems Corporation Tripter X-1 Compact Duet is a "special 510(k)" submission. This type of submission is used for modifications to a manufacturer's own legally marketed device (the predicate device) where the modification does not affect the intended use or fundamental scientific technology, and does not raise new questions of safety or effectiveness.
Because it was deemed a "minor modification," the submission relied heavily on:
- Substantial equivalence to predicate devices: The core argument is that the Duet shares the "same fundamental scientific technology and intended use" as its own prior device (Tripter X-1 Compact) and other legally marketed ESWL devices.
- Compliance with recognized electrical and safety standards: Extensive testing against IEC and UL standards confirmed its safety from an engineering perspective.
- Lack of requirement for new clinical data: The FDA agreed that "No clinical tests were performed" were necessary because the modification ("enables the use of 2 reflectors instead of one") was not considered to introduce new risks or alter the fundamental mechanism of action that would necessitate new human trials.
§ 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.”)