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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 a 510(k) premarket notification for the "Shockwave Medical Lithoplasty System" (K163306), which is a medical device for lithotripsy-enhanced balloon dilation in peripheral arteries. This submission is for a modified version of a previously cleared device (K161384).

Here's an analysis of the provided information about acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format. Instead, it broadly states that:

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Component level testing" for the tri-port hub, and "hardware, electrical performance, electromagnetic compatibility, and software verification and validation tests." However, it does not specify the sample sizes used for these tests.

The data provenance is not mentioned. Given the nature of these tests (design verification and validation), they are typically conducted in a laboratory setting by the manufacturer. They are not clinical studies with patient data from a specific country or with retrospective/prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to the information provided. The document describes engineering and performance testing of a medical device, not a diagnostic algorithm or image analysis system that requires expert ground truth assessment. The "ground truth" here refers to the device's adherence to engineering specifications and performance standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human assessment (e.g., image interpretation) to resolve discrepancies among experts. The tests described are engineering verification and validation, where performance is measured against objective standards.

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

This section is not applicable. The device described is a physical interventional medical device (lithotripsy-enhanced balloon dilatation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is not an algorithm, but a physical medical system. The performance testing described is for the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the engineering and performance tests described, the "ground truth" implicitly refers to:

• Established engineering specifications and design input requirements: The device's performance was compared against these predefined physical and functional parameters.
• International and national standards: Compliance with standards like ISO 594-1/2, ANSI/AAMI ES60601-1, and IEC 60601-1-2 serves as the ground truth for safety and compatibility.

8. The sample size for the training set

This section is not applicable. The device is not an AI algorithm that requires a training set. The tests performed are for hardware and software verification and validation related to the device's design and manufacturing changes.

9. How the ground truth for the training set was established

This section is not applicable as there is no training set for this type of medical device.

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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.

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.

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