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The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL 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 IVL 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 IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are non-sterile reusable devices.

The provided text is a 510(k) Summary for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System. It details an application for a software change to an already cleared predicate device (K163306). The information provided focuses on demonstrating substantial equivalence to the predicate device due to these software changes.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics. Instead, it states that "Objective evidence demonstrating that the IVL System design output meets the product design input requirements as well as that device performance characteristics conform to user needs and intended uses as defined in the product specification was provided."

The "Summary of Performance Data" lists the types of testing performed and concludes: "Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required."

The performance data listed indirectly demonstrates adherence to certain acceptance criteria for the modified software and the overall device:

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

The document primarily describes design verification and validation testing of hardware and software components, and in vivo chronic animal testing. It does not specify sample sizes (e.g., number of catheters tested, number of animals) for these tests, nor does it explicitly state the country of origin of the data or whether the animal study was prospective or retrospective.

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 510(k) summary focuses on engineering and animal testing, not human clinical trials or diagnostic accuracy studies involving expert interpretation. Therefore, direct information on the number or qualifications of experts establishing ground truth for a test set (e.g., in medical image interpretation) is not applicable and not provided in this document.

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

Given that human clinical trials involving expert interpretation of a test set are not described, an adjudication method is not applicable and not provided.

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

An MRMC comparative effectiveness study is not applicable and was not done as this 510(k) is for a medical device (intravascular lithotripsy system) and its software update, not an AI-based diagnostic or assistive technology for human readers.

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

This refers to the performance of the device itself (the IVL system) in its intended function. The "Summary of Performance Data" describes various tests conducted to demonstrate the standalone performance of the IVL System, including:

• Software verification and validation
• IVL Catheter design verification (e.g., balloon diameter, compliance, bond strength)
• Mechanical performance (sonic output, pressure leakage, balloon fatigue)
• System integration
• Acoustic field mapping
• In vivo chronic animal testing

These tests evaluate the device's ability to meet its design specifications and perform its intended function without human intervention in the core lithotripsy mechanism. The conclusion is that "Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use."

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

For the engineering and animal studies, "ground truth" would be established through:

• Engineering specifications and test methodologies: For mechanical, electrical, and software validation tests (e.g., bond strength is measured against a specified minimum, balloon diameter against a nominal value, software functions tested against requirements).
• Pre-clinical animal models: For chronic animal testing, the ground truth would be the physiological and histological observations in the animals, evaluated to assess the biological response and safety of the device.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning, as this 510(k) is for a medical device with an updated software, not a machine learning algorithm. The software changes refer to updates in display logic, power saving features, and extending the maximum pulse lifetime based on design validation rather than a learning algorithm.

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

As there is no mention of a machine learning training set, this question is not applicable. The "ground truth" for the software validation and device testing would be the pre-defined design specifications, engineering requirements, and expected physiological responses in animal models.

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