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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 with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries, prior to final treatment.

Not for use in the coronary, carotid, cerebral, or pulmonary 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. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing dilation of peripheral artery stenosis.

The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is racilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses.

The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile.

The IVL Generator and Connector Cable are used with the Shockwave Javelin Peripheral IVL Catheter to deliver localized, lithotripsy-enabled modification and crossing of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device 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.

Ask a specific question about this device

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, popliteal, infra-popliteal, 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 balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are nonsterile reusable devices.

This document describes the regulatory submission for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System, specifically for a Special 510(k) Premarket Notification. The submission focuses on modifications to an already cleared predicate device (Shockwave Medical Intravascular Lithotripsy System, K203365). Therefore, the "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed on these modifications, rather than a full de novo clinical trial.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with numerical acceptance criteria values and corresponding reported performance metrics. Instead, it broadly 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 types of testing performed, which would be designed against underlying acceptance criteria, are listed as:

• User interface
• Battery system (charging, management)
• System power supplies
• Internal system verification
• Control system
• Catheter management system
• Pulse delivery system |
  | Software Verification and Validation | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" for:
• Unit Test
• Integration Test
• System Test
• Regression Test |
  | Extended Life Testing | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
  | 60601-1 Type Testing (Safety and EMC) | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
  | Transit Testing | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for any of the testing performed (e.g., number of units tested, number of software test cases). Given that this is a Special 510(k) for modifications to an existing device, the testing would likely involve design verification and validation on a limited sample of physical devices and extensive software testing.

The data provenance is implied to be from internal Shockwave Medical, Inc. testing facilities, as it states "Testing was conducted in accordance with Shockwave Medical's Risk Analysis procedures". It does not specify country of origin for the data or whether the data was retrospective or prospective in detail, but given it's device verification, it would be prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts, qualifications, ground truth establishment) is typically associated with clinical studies involving human interpretation or pathology. Since this submission relies on engineering and software verification and validation, such expert involvement for "ground truth" as it's typically understood in clinical AI/MRMC studies is not applicable or described. The "ground truth" for this device's performance is established by its design specifications and validated through engineering tests.

4. Adjudication Method for the Test Set

Not applicable, as this is primarily engineering and software verification and validation, not a multi-reader clinical study requiring adjudication.

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

No MRMC study was done or described. The device is a physical medical device (catheter, generator) for lithotripsy, not an AI-assisted diagnostic tool.

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

This refers to the performance of the physical device itself and its modified hardware and software functionalities. The performance testing done (hardware, software, life testing, safety, EMC, transit) represents the "standalone" performance of the modified device components satisfying their design requirements.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on design specifications and engineering requirements. The performed tests (hardware, software, electrical safety, etc.) verify that the device's output and performance characteristics meet these predefined specifications, which are themselves derived from user needs and intended uses. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, as this is a modification submission for an already cleared device where clinical data was previously provided or deemed unnecessary for the original clearance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that requires a "training set". The "training" here refers to the manufacturing and design processes that lead to the device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of an AI algorithm.

Ask a specific question about this device

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, popliteal, infra-popliteal, 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 Mr+ 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.

The provided document, a 510(k) summary for the Shockwave Intravascular Lithotripsy (IVL) System, outlines the device's technical specifications and how it demonstrates substantial equivalence to a predicate device. However, it does not include information about a study that utilized acceptance criteria based on accuracy metrics for an AI/ML device, nor does it detail typical components of such studies (like sample sizes for test/training sets, expert adjudication, or MRMC studies).

The document is primarily a notification to the FDA about modifications to an existing medical device and its continued substantial equivalence, rather than a clinical trial report or a performance study for an AI/ML diagnostic.

Therefore, I cannot extract the requested information because the provided text describes a medical device (intravascular lithotripsy system) approval process based on substantial equivalence to a predicate device, which focuses on device design and performance verification testing, not an AI/ML model's diagnostic accuracy or a related clinical study involving human readers and ground truth establishment.

The sections you requested, such as acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, are typical for evaluations of AI/ML diagnostic devices. This document describes a physical medical device (catheter-based system) and its mechanical/electrical performance, not an AI/ML system's diagnostic performance.

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The Shockwave Medical Peripheral 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, infra-popliteal, 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 arterv stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in 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.

This document is a 510(k) Premarket Notification for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System, specifically focusing on minor modifications to the IVL Catheter. The document asserts substantial equivalence to a previously cleared predicate device (K180454).

Based on the provided text, the device in question is a medical device and not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML specific acceptance criteria, test set composition, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to this submission. The device's performance is demonstrated through design verification and validation testing of the physical device, not through an AI/ML model's performance on annotated data.

Here's the breakdown based on the information provided, and where the requested details are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various performance tests conducted to demonstrate that the IVL System design output meets product design input requirements and conforms to user needs. These are engineering and mechanical performance criteria for a physical device.

2. Sample size used for the test set and the data provenance:

This is not applicable in the context of an AI/ML test set. The "test set" here refers to the physical devices (IVL Catheters) and their components that underwent various engineering and mechanical tests. The document does not specify the number of units tested for each criterion, but it implies a standard process of design verification and validation testing. The "data provenance" would refer to the conditions under which these physical tests were performed, which are standard laboratory/manufacturer testing environments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in this context refers to the performance specifications of the physical device, established through engineering requirements and testing. It does not involve expert annotation of images or data, as there is no AI/ML component.

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

Not applicable, as this refers to a process typically used for human annotation disagreements in AI/ML model training/testing. The device undergoes objective physical and mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. MRMC studies are used to evaluate human reader performance, typically in diagnostic imaging, with and without AI assistance. This device is a physical medical instrument, not an AI diagnostic tool.

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

Not applicable. This question concerns the performance of an AI algorithm in isolation. This device is a physical system.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by engineering specifications, design requirements, and objective physical/mechanical measurements rather than expert consensus, pathology, or outcomes data in the sense of a diagnostic claim. The tests verify that the device meets its design inputs and functions as intended, providing "objective evidence."

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable, as there is no AI/ML training set.

Ask a specific question about this device

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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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 iliac, femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical IVL System has three components: a proprietary balloon Catheter, a Generator, and a 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 balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and Connector Cable are non-sterile reusable devices.

The provided text is a 510(k) Summary for the Shockwave Medical Intravascular Lithotripsy (IVL) System, specifically for a line extension (Shockwave S4 IVL Catheter). This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a standalone AI/algorithm device and proving its performance against those criteria.

Therefore, the information required to answer the prompt's questions about acceptance criteria, study design for AI/algorithm performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not present in the provided text.

The document discusses:

• Device Description and Indications for Use: The Shockwave Medical IVL System, its components, and its intended use for lithotripsy-enhanced balloon dilatation in peripheral vasculature.
• Technological Comparison: Details how the new S4 Catheter sizes compare to the predicate device, highlighting similarities in intended use, principles of operation, and technological characteristics, while noting updates in materials, emitter design, and packaging.
• Summary of Performance Data (Bench and Biocompatibility): This section describes the engineering and material performance tests (e.g., tensile strength, kink resistance, balloon inflation/deflation, biocompatibility tests) conducted to ensure the device meets design specifications and is substantially equivalent. These are not 'acceptance criteria' in the context of an AI algorithm's diagnostic or predictive performance.
• Clinical Study (DISRUPT BTK Study): This was a clinical study of the predicate device's configuration to assess its safety and effectiveness in treating stenotic, infrapopliteal arteries. It evaluated clinical endpoints like Major Adverse Events (MAE) and reduction in percent diameter stenosis, and procedural success. This is a clinical trial for a medical device, not a study to prove AI algorithm performance.

In summary, the provided document does not contain the information requested in the prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving its performance.

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