(118 days)
The Shockwave Medical Lithoplasty System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
The Shockwave Medical Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
The Lithoplasty Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and Connector Cable are non-sterile reusable devices.
This document describes the Shockwave Medical Lithoplasty System, a device for treating peripheral arterial disease. The provided information is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone clinical study report. Therefore, some of the requested information cannot be fully extracted in the format requested, particularly for a comparative effectiveness study (MRMC) or a standalone AI algorithm study. However, I can provide the available information regarding the clinical study and its endpoints, which serve as acceptance criteria for safety and effectiveness.
Here's the summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The clinical study (DISRUPT PAD program) established primary and secondary endpoints for safety and effectiveness. These endpoints effectively serve as the acceptance criteria for the device's clinical performance.
| Criterion Type | Acceptance Criteria (Performance Goal) | Reported Device Performance (Clinical Study Results) |
|---|---|---|
| Primary Safety | Freedom from Major Adverse Events (MAE) at 30 days: lower bound of 95% Confidence Interval > 91.3% | Freedom from MAE at 30 days: 100% (lower bound of 95% CI was 97.0%) |
| Primary Effectiveness | Procedural success (defined as 89.3% | Procedural success: 100% (lower bound of 95% CI was 97.0%) |
| Secondary Safety | Freedom from MAE at 6 months | Freedom from MAE at 6 months: 96.8% |
| Secondary Effectiveness | Target lesion patency at 6 months | Target lesion patency at 6 months: 76.7% |
| Secondary Effectiveness | Target lesion revascularization (TLR) within 6 months | TLR within 6 months: 3.2% |
| Other Functional Outcomes | Sustained and statistically significant improvement in ABI, Rutherford Category, and walking impairment from baseline at 30 days and 6 months. | Achieved sustained and statistically significant improvements for ABI, Rutherford Category, and walking impairment. |
2. Sample Size and Data Provenance for the Test Set (Clinical Study)
- Sample Size: 95 subjects were enrolled in the clinical study (DISRUPT PAD Program). 94 of these subjects received treatment with the Lithoplasty System.
- Data Provenance: Prospective, multi-center study conducted at seven sites in Austria, New Zealand, and Germany.
3. Number of Experts for Ground Truth and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish ground truth for the clinical study endpoints. However, it does mention that "Core Lab" was involved in assessing calcium burden severity.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for the clinical study endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described in this document. This document pertains to a medical device (Shockwave Medical Lithoplasty System) and its clinical performance, not an AI-powered diagnostic or assistive tool.
6. Standalone Performance Study (Algorithm Only)
No, a standalone (i.e., algorithm only without human-in-the-loop performance) study was not done, as this document is about a physical medical device.
7. Type of Ground Truth Used (Clinical Study)
The ground truth for the clinical study was established through clinical outcomes and measurements, including:
- Procedural success: Defined by a reduction in stenosis measured angiographically.
- Major Adverse Events (MAE): Defined clinically.
- Target lesion patency: Assessed by duplex ultrasound.
- Target lesion revascularization (TLR): Clinically observed and recorded events.
- Functional outcomes: Measured using Ankle-Brachial Index (ABI), Rutherford Category, and walking impairment assessments.
- Calcium burden: Assessed by a Core Lab.
8. Sample Size for the Training Set
This question is not applicable. The document describes a medical device study, not an AI algorithm, so there is no "training set" in the context of machine learning. The clinical study involved 95 patients; this is the test set for evaluating the device's performance.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).