(463 days)
CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
ESWL, model CS-2012A-3, is an mobile electromagnetic lithotripter with a focal zone to treat patients, the shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an spherical concave electromagnetic coil, a membrane and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient.
It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
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 and/or US equipment.
The device includes following parts:
- ESWL device
The ESWL device contains therapy head, main switch, control panel, target indicator and foot pedal. It also provides patient with treatment, controls functions of CS-2012A-3. - Therapy table
Therapy table consists of table (For personal hygiene, the table should be covered by disposable medical nonwoven fabrics in treatment), table supporter and 3-dimension movement.
Patient is positioned on therapy table. Table cutout area allows positioning of therapy table near patient, table can be moved as required. Table motion is completely independent of ESWL device. It has its own 3 dimension movement, not to link CS-2012A-3.
The provided document describes the acceptance criteria and study data for the Extracorporeal Shock Wave Lithotripter, model CS-2012A-3.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are implicitly demonstrated through its compliance with various standards and the outcome of the clinical study, particularly the success rate. The specific "acceptance criteria" for the clinical study's success rate are not explicitly stated as a numerical threshold in isolation but are presented as the achieved performance which is deemed satisfactory for substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance (Clinical Study) |
|---|---|
| Device operates safely and effectively | Overall success rate of 80% |
| Device is as safe and effective as predicate devices | Confirmatory clinical study demonstrates substantial equivalence |
| User manual is adequate for operation | User's manual evaluated as adequate |
| Low incidence of device malfunction | No device malfunction reported |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 144 patients (105 male, 39 female).
- Data Provenance: The document states that "clinical investigations were performed at 2 sites." The country of origin is not explicitly stated for these clinical sites, but the manufacturer is Suzhou Xixin Medical Instruments Co., Ltd. from China, suggesting the studies likely took place in China. The studies were prospective in nature, described as "clinical investigations were performed... to support this application."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth for the clinical test set. It mentions that the device is "intended for use by attending physician" and that "experiences of physicians have shown that patients treated by the CS-2012A-3 are safe and having high evaluations". This suggests that the clinical outcomes (e.g., stone fragmentation, removal) assessed by the attending physicians served as the ground truth, but the details of their roles in data adjudication are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "overall success rate" was measured, implying a clinical assessment of treatment efficacy by the medical professionals involved in the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical study focused on the performance of the CS-2012A-3 device itself, not on comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
This device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed.
7. Type of Ground Truth Used (Clinical Test Set)
The ground truth for the clinical test set was based on clinical outcomes. Specifically, the "overall success rate" of the treatment was measured, with success presumably defined by the fragmentation and/or removal of kidney and ureteral calculi. The document mentions "patients with stones were treated" and the evaluation of the "device function."
8. Sample Size for the Training Set
The document does not refer to a "training set" as this device is a physical medical instrument, not a machine learning or AI model that requires a data training set. The development and validation of the device would have involved engineering tests and potentially pre-clinical studies, but not a data training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable to this device.
§ 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.”)