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The BraidE Embolization Assist Device is indicated for use in the peripheral vasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked peripheral aneurysms with a neck width ≤ 10 mm. A wide-necked peripheral aneurysm defines the neck width as > 4 mm or a dome-to-neck ratio < 2.

The BraidE Embolization Assist Device is a sterile single use endovascular device intended to provide temporary assistance for the coil embolization of wide-necked peripheral aneurysms. The BraidE is comprised of a nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The braided mesh at the distal portion of the device is shown in Figure 2. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider. Because the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the aneurysm neck morphology and vessel requirement.

This document describes the regulatory acceptance of the BraidE Embolization Assist Device, leveraging data primarily from the Comaneci Embolization Assist Device due to shared design features. The core of the acceptance criteria and supporting studies are presented below:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" section, which outlines the requirements for clinical, animal, and non-clinical performance, as well as biocompatibility and labeling. The reported device performance is extracted from the "Summary of Clinical Information" and "Summary of Nonclinical/Bench Studies" sections.

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

• Test Set Sample Size:
  • Clinical (Neurovascular): 63 patients / 64 intracranial aneurysms.
  • Clinical (Peripheral): 6 patients across 3 case studies.
  • Animal: 20 rabbits (used to create 23 aneurysms).
• Data Provenance:
  • Clinical (Neurovascular): Retrospective collection from two sites outside the United States: Walton Center in Liverpool, United Kingdom, and University Hospital St. Ivan Rilski in Sofia, Bulgaria. Data collected between March to December 2017.
  • Clinical (Peripheral): Reported in the clinical literature (3 publications) - specifics on country of origin for these individual cases are not provided.
  • Animal: Conducted in a rabbit model (Good Laboratory Practice (GLP) standards). Location not specified.
  • Non-clinical/Bench: Performed internally or by contract labs.

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

• Clinical (Neurovascular - Retrospective Study):
  • Imaging Data (Technical Success and Safety): Independently analyzed by the Angiography and Noninvasive Imaging Core Lab at the University of California - Los Angeles (UCLA) in Los Angeles, California. No specific number or qualifications of individual experts from the core lab are provided, but a core lab typically implies specialized radiologists/neuro-interventionalists.
  • Adverse Events (AE): Adjudicated independently by the Department of Neurology at the University of Southern California (USC). No specific number or qualifications of individual experts from the department are provided, but a neurology department implies neurologists with relevant expertise.
• Clinical (Peripheral - Case Studies): The ground truth for effectiveness (aneurysm exclusion/occlusion, patency) and safety observations would have been established by the treating physicians and reported in their publications. No specific number or qualifications of experts beyond the authors of these publications are provided.
• Animal Study: Aneurysmal healing was characterized by light microscopy and en face assessment by scanning electron microscopy (SEM). Histologic indicators of vessel wall healing were determined by light microscopy and SEM. These analyses would be performed by trained pathologists/histologists. No specific number or qualifications are mentioned.

4. Adjudication Method for the Test Set

• Clinical (Neurovascular - Retrospective Study):
  • Imaging data for technical success and safety were independently analyzed by the Angiography and Noninvasive Imaging Core Lab at UCLA.
  • Adverse events (AE) were adjudicated independently by the Department of Neurology at USC.
  • This suggests independent review by specialized entities, but no specific 'X+Y' method (e.g., 2+1, 3+1) for individual case agreement is explicitly stated within these "independent" reviews.
• Clinical (Peripheral - Case Studies): The data presented are observational reports from published case studies. There's no indication of an independent adjudication method for these specific cases beyond the reporting clinicians' assessments.
• Animal Study: The analyses (microscopy, SEM, angiographic evaluations) would involve expert interpretation. No explicit adjudication method for disagreements is described beyond the reporting of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly done in the provided text. The clinical data focuses on device performance in specific populations, and a "control device" was used in the animal study for comparison, but this is not framed as a human MRMC comparative effectiveness study. Human readers (clinicians) were involved in the treatment and assessment, but the study design was not an MRMC study comparing human readers' performance with and without AI assistance. The device itself is an assistive tool, not an AI diagnostic/interventional algorithm.

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

This question is not applicable as the BraidE Embolization Assist Device is a physical medical device intended for human-in-the-loop (physician) use to assist in procedures, not an AI algorithm.

7. The Type of Ground Truth Used

• Clinical (Neurovascular - Retrospective Study):
  • Technical Success: Established by independent analysis of imaging data (angiography) by a core lab.
  • Safety/Adverse Events: Established by independent adjudication by a neurology department based on clinical observation and reported events.
• Clinical (Peripheral - Case Studies): Clinical outcomes (aneurysm exclusion, vessel patency) observed and reported by treating physicians, likely based on imaging (e.g., CTA) and clinical assessment.
• Animal Study: Gross, histological, and clinical chemistry evaluations, combined with angiographic assessments and scanning electron microscopy (SEM), constituted the ground truth for safety and performance in the animal model.
• Non-clinical/Bench Studies: Physical measurements, material analysis, and simulated performance tests against predetermined specifications.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI algorithm or a de novo clinical trial for this device. The clinical "training" data for the BraidE (a physical device) would be the experience gained with the predecessor Comaneci device.

• The BraidE device leverages data from the Comaneci device. The Comaneci device itself was evaluated in a "historical post-market data" retrospective study involving 63 patients (64 intracranial aneurysms). This data effectively serves as the "prior experience" or "training" knowledge base for the regulatory acceptance of the BraidE, especially since BraidE shares clinically relevant design features.
• The "training plan for the use of the device with the novel adjustment feature of the mesh region was provided as part of the review," suggesting educational materials for physicians, rather than an algorithmic training set.

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

As noted above, "training set" here refers to the clinical experience/data gathered from the Comaneci device, which is leveraged for the BraidE.

• For the neurovascular retrospective study of the Comaneci device:
  • Technical success and safety imaging data: Independently analyzed by the Angiography and Noninvasive Imaging Core Lab at UCLA.
  • Adverse events: Independently adjudicated by the Department of Neurology at USC.
• For the peripheral case studies of the Comaneci device: Ground truth was established by the treating physicians' assessments based on procedural outcomes, follow-up imaging (e.g., CTA), and clinical observations, as reported in the literature.

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