(148 days)
The Piezolith 3000 is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The Piezolith 3000 is comprised of the following principal components: (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X-ray imaging is used) mounted to a swivel slide on C-arm; (2) a control console; (3) an X-ray; (4) ultrasound imaging system for localization; and (5) a treatment table.
The provided text describes the UMS's Piezolith 3000 Lithotripter and its 510(k) submission. However, it does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC study results, types of ground truth for training).
The document is a summary of the 510(k) submission and primarily focuses on demonstrating substantial equivalence to predicate devices, outlining the device's technical characteristics, and conforming to voluntary consensus standards.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Voluntary Consensus Standards: | Conforms to the following standards: |
| IEC 60601-1: 1988 with Amdt 1, 1991 and Amdt 2, 1995 "Medical electrical equipment" | Conforms |
| IEC 60601-1-1: 1992 with Amdt 1, 1995 "Medical electrical equipment; Part 1: General requirements for safety" | Conforms |
| IEC 60601-1-2: 1993 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests; 62A/336/FDIS" | Conforms |
| CISPR 11: 1990 "Limits and Methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment" | Conforms |
| IEC 60601-2-36: 1997 "Medical electrical equipment: Part 2 Particular requirement for the safety of equipment for extracorporeally induced lithotripsy" | Conforms |
| Reference for measurements: | Utilized as reference: |
| IEC 61846: 1998 "Ultrasonic - Pressure pulse lithotripters -Characteristics of field" | Utilized as reference for measurements |
| Functional Performance: | Demonstrated Performance: |
| Shock wave characterization | Measurements performed and implied acceptable, as device "functioned as intended and performed as expected." |
| Localization accuracy | Measurements performed and implied acceptable, as device "functioned as intended and performed as expected." |
| Road testing | Performed and implied acceptable, as device "functioned as intended and performed as expected." |
| Clinical Data (Substantial Equivalence) | Clinical data demonstrated substantial equivalence to predicate devices. |
| Overall Intended Use | "In all instances, the Piezolith 3000 functioned as intended and performed as expected." |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document mentions "clinical data" but provides no details on its size, country of origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not stated. The document does not mention the use of experts for establishing ground truth or their qualifications.
4. Adjudication method
- Not stated. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not stated. This device is a lithotripter, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not stated. This device is a physical medical device (lithotripter) with human operation, not an algorithm.
7. The type of ground truth used
- For the physical performance tests (shock wave characterization, localization accuracy, road testing), the ground truth would be based on physical measurements against engineering specifications and industry standards.
- For the "clinical data" mentioned, the nature of the ground truth (e.g., successful stone fragmentation, patient outcomes) is not detailed. It is mentioned to demonstrate substantial equivalence, implying comparison to established outcomes of predicate devices.
8. The sample size for the training set
- Not applicable / Not stated. This document does not describe the development of an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not stated.
In summary, the provided text is a regulatory summary for a medical device (a lithotripter) focusing on substantial equivalence and adherence to engineering standards. It does not contain the detailed study information typically found for an AI/algorithm-based device and therefore cannot fully answer many of your questions which are more relevant to those types of devices.
§ 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.”)