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510(k) Data Aggregation
(145 days)
The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The Piezolith 3000 Triple Focus consists of (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 (LITHOARM); (2) a control console (device trolley); (3) ultrasound imaging system for localization; (4) an optional X-ray system for localization; and (5) a treatment table.
The provided text describes a 510(k) premarket notification for the Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against those criteria. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and performance metrics is not explicitly available in the provided document sections.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device functions as intended without posing new safety risks compared to predicate devices. | "In all instances, the Piezolith 3000 Triple-Focus functioned as intended and the results observed were as expected." |
| Effectiveness: Device effectively fragments urinary stones in the kidney and ureter, comparable to predicate devices. | "Bench and clinical testing was performed using the Piezolith 3000 Triple Focus." The device is claimed to be "as safe and effective as the Piezolith 3000 (K032958), the Karl Storz Modulith Lithotripter (K010340, K012482, K011700), and the Direx Systems Corporation Integra (K053640, K062147)." |
| Compliance with Standards: Device meets relevant electrical, medical device, and lithotripsy standards. | "the modified device was tested according to the following standards: IEC 60601-1 (1988) (including Amendment 1(1991) and Amendment 2 (1995)); IEC 60601-1-1 (2000) with Amendment 1, 1995; IEC 60601-1-2 (2001); IEC 60601-2-36 (1997); IEC 61846 (1998)." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and clinical testing" but does not specify the sample size for any clinical test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described is a comparison against predicate devices and adherence to standards rather than an independent expert-validated ground truth study.
4. Adjudication Method for the Test Set
This information is not provided as no specific "test set" requiring expert adjudication is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, an MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned in the document. This is a medical device (lithotripter), not an AI diagnostic tool that assists human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm-only device. It's a physical medical device. The "performance data" refers to the device's physical capabilities and operational characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance demonstration is primarily:
- Performance against predicate devices: The Piezolith 3000 Triple Focus is deemed "substantially equivalent" in safety and effectiveness to existing, legally marketed lithotripters. This implies that the accepted performance of previous devices serves as a benchmark.
- Compliance with recognized standards: The device met specific IEC standards related to medical electrical equipment and lithotripters.
- Functionality as intended: General statement about the device functioning as expected.
No specific, independent "expert consensus, pathology, or outcomes data" is detailed as being used for a distinct "ground truth" to validate the device's primary efficacy in the context of this 510(k) summary.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Piezolith 3000 Triple Focus is a physical medical device, not a machine learning model that undergoes "training" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as above.
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(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.
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