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The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.

The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis.

The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer.

The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.

Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets the acceptance criteria. It's important to note that the provided text is an FDA 510(k) summary, which often provides high-level summaries of acceptance criteria and performance rather than detailed tables for every test.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative for many of the bench tests (e.g., "meets its design specifications"). For the clinical studies, quantitative performance goals are provided.

Bench and Animal Testing Acceptance Criteria & Performance:

Clinical Study (RESTORE ATK & RESTORE BTK) Acceptance Criteria & Performance:

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The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.

The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

This document is a 510(k) Summary for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to a predicate device.

Based on the provided information, the device discussed is primarily a mechanical device (a catheter system that uses lithotripsy) and not an AI/ML powered device. The document does not contain the specific information requested in questions 1 through 9, which are typically associated with the acceptance criteria and study designs for AI/ML-powered medical devices. The performance data section refers to "design verification and validation testing" for mechanical and electrical properties (e.g., guidewire compatibility, balloon diameter, sonic output, pulse rate), not AI/ML model performance metrics.

Therefore, I cannot provide a response filling in the requested table and answering questions 1-9 accurately, as the provided text does not contain information about acceptance criteria, study details, expert involvement, or ground truth for an AI/ML-powered device.

To answer your request, the provided document does not contain the necessary information regarding: AI/ML acceptance criteria, performance metrics, sample sizes for AI/ML test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment relevant to an AI/ML device.

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The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

The Shockwave E Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.

The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

The provided text does not contain information about acceptance criteria for device performance in a clinical study, nor does it detail a clinical study that proves the device meets specific performance criteria.

The document is a 510(k) Pre-Market Notification from the FDA for a device called the "Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter". It states that the device is substantially equivalent to a legally marketed predicate device (K191840) and a reference device (K203365).

The "Summary of Performance Data" section (on page 6 of the input) lists various design verification and validation tests that were conducted to ensure the device meets its design specifications and conforms to user needs. These are engineering and performance tests on the device itself, rather than clinical efficacy or safety studies with human subjects.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance (as it pertains to clinical data).
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size with AI assistance.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "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." This indicates that no clinical study was performed or needed for this 510(k) clearance, and thus, no such clinical data is available in the provided text.

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

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen. and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.

The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

This document describes the premarket notification (510(k)) for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter. It is important to note that this document pertains to a medical device for physical intervention, not an AI/Software as a Medical Device (SaMD). As such, many of the requested criteria, particularly those related to AI model development, ground truth establishment, expert review, and MRMC studies, are not applicable to this device.

The document details the device's design, intended use, and the engineering tests conducted to demonstrate its safety and effectiveness.

Here’s a breakdown of the information provided, addressing the questions where applicable to this medical device:

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

The document does not present a formal table of "acceptance criteria" in terms of specific numerical thresholds for clinical performance or diagnostic accuracy (as would be seen for a SaMD). Instead, it lists extensive engineering and design verification and validation tests whose successful completion serves as the "acceptance criteria" for demonstrating substantial equivalence. The "reported device performance" is that the device met all these specifications.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each engineering test. These tests typically involve a defined number of units tested to statistical confidence levels based on accepted engineering practices and standards (e.g., ISO, ASTM). The "data provenance" is controlled laboratory testing and animal studies, not patient data in the typical sense of a clinical trial for diagnostic performance. The document states "Confirmatory chronic GLP animal testing" was performed, indicating a controlled laboratory environment. No country of origin for such data is explicitly mentioned, but it's generated by Shockwave Medical, Inc. in Santa Clara, California, USA. The studies are not described as retrospective or prospective in the clinical trial sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a physical medical device like this, "ground truth" is established by engineering specifications, physical measurements, and established physiological responses in animal models, not by expert human interpretation of images or other clinical data.

4. Adjudication method for the test set
This question is not applicable. Adjudication is relevant for subjective assessments, particularly in clinical or diagnostic contexts where human interpretation can vary. Engineering tests have objective pass/fail criteria or measurements against specifications.

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 question is not applicable. An MRMC study is relevant for evaluating the performance of AI/SaMD devices, particularly in diagnostic imaging. This submission is for a physical medical device (catheter system), not an AI. The document states: "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."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as there is no algorithm or AI component to this device.

7. The type of ground truth used
The "ground truth" for this device's performance validation is based on engineering design specifications, physical measurements, and performance in controlled in vitro (bench) and in vivo (animal) studies. This is standard for demonstrating the safety and effectiveness of a physical medical device and its substantial equivalence to a predicate.

8. The sample size for the training set
This question is not applicable. There is no AI model or "training set" for this physical device.

9. How the ground truth for the training set was established
This question is not applicable. There is no AI model or "training set" for this physical device.

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