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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:

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

The "test set" in this context refers to the clinical study populations.

• RESTORE ATK Study (Above-the-Knee):

  • Sample Size: 95 adult subjects.
  • Data Provenance: Prospective, non-randomized, multicenter, single-arm study conducted at 10 sites in Croatia, Germany, and Austria.

• RESTORE BTK Study (Below-the-Knee):

  • Sample Size: 20 subjects plus 1 roll-in subject (total 21 consented, 20 treated in the analysis, 18 successfully underwent IVL procedure).
  • Data Provenance: Prospective, non-randomized, multicenter, single-arm study conducted at 3 sites in Austria, Germany, and Lithuania.

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

The document mentions an "independent angiographic core laboratory" for assessing calcification severity and residual stenosis.

• Number of Experts: Not specified.
• Qualifications of Experts: The document does not explicitly state the qualifications of the experts in the core laboratory (e.g., "radiologist with 10 years of experience"). It only identifies them as an "independent angiographic core laboratory" which implies specialized expertise in interpreting angiographic images.

4. Adjudication Method for the Test Set

The document does not specify a separate adjudication method for the core lab assessments beyond stating that the assessment was done by an "independent angiographic core laboratory." This implies that the core lab's findings serve as the ground truth.There's no mention of 2+1 or 3+1 methods.

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 describes a medical device (intravascular lithotripsy system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The study evaluates the device's direct clinical outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Again, this is a medical device (hardware and associated catheter), not a standalone algorithm. Thus, a standalone algorithm performance evaluation is not applicable and was not performed. The device's performance is inherently tied to its use by a clinician.

7. The Type of Ground Truth Used

For the clinical studies (RESTORE ATK and RESTORE BTK), the ground truth for effectiveness endpoints was established through:

• Angiographic Core Laboratory Assessment: For residual stenosis and calcification severity.
• Clinical Outcomes Data: Such as freedom from MAEs, freedom from revascularization, freedom from amputation, and changes in functional outcomes (ABI, Rutherford Category).
• Duplex Ultrasound (DUS): For target lesion patency assessment in RESTORE ATK.

For the initial bench and animal studies, the ground truth was established through:

• Design Specifications: For bench testing.
• Histopathology Evaluation: For the animal study.
• ISO and GLP Standards: For biocompatibility and animal studies.

8. The Sample Size for the Training Set

The document describes clinical studies that are evaluating the performance of a manufactured medical device, not training a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The device's design and manufacturing are based on established engineering principles and prior knowledge.

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

As explained in point 8, there is no "training set" in the AI/ML sense for this device. The development of the device's design (which could be considered analogous to a "training phase" for a typical product) would rely on:

• Engineering design principles and specifications.
• Pre-clinical research and development.
• Prior knowledge from predicate devices and scientific literature.
• Bench testing and animal studies during the development phase.

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