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

The Comaneci Embolization Assist Device consists of three device models: Comaneci, Comaneci Petit, and Comaneci 17 (see Table 1). The Comaneci Embolization Assist Device is intended for temporary use and is introduced through an endovascular approach to the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width < 10 mm. The device consists of a nitinol fine wire mesh region at the distal end mounted on a flexible shaft that expands and contracts when the physician pulls a core wire that is coated with polytetrafluoroethylene (PTFE) and connected to a handle with a control slider made of a styrene-butadiene copolymer (Figures 1 and 2). The fine wire mesh region on the Comaneci Embolization Assist Device is unique in that it is not self-expandable but is directly controlled by the physician to size this region of the device to the parent vessel. The wires of the mesh are radiopaque, which allows the physician to visualize the mesh under fluoroscopy. The Comaneci and Comaneci Petit models are delivered through a microcatheter with an internal diameter (ID) of 0.021 inches and the Comaneci 17 is delivered through a microcatheter with an ID of 0.017 inches. The devices are packaged in a sterile pouch and are intended for single use only.

The Comaneci Embolization Assist Device is a Class II device (Product Code: PUU, Regulation Number: 21 CFR 882.5955) intended for temporary use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.

The acceptance criteria for the Comaneci Embolization Assist Device, as derived from the provided text, are multifaceted, encompassing non-clinical bench testing, animal studies, and a retrospective clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly presented in a single table with numerical targets, but rather are implicitly defined by the successful outcomes of various tests and the conclusions drawn from them. Below is a structured presentation of the implicit acceptance criteria based on the described studies and the reported device performance.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a multi-faceted approach involving extensive non-clinical bench testing, an animal study, and a retrospective clinical case series. The "Summary of Clinical Information" section specifically details the human study.

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

• Test Set Sample Size (Clinical Study): 63 consecutively treated patients with 64 intracranial aneurysms.
• Data Provenance:
  • Country of Origin: The study was conducted outside the United States (OUS) at two sites: Walton Center in Liverpool, United Kingdom, and University Hospital St. Ivan Rilski in Sofia, Bulgaria.
  • Retrospective or Prospective: Retrospective post-market collection.

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

• Imaging Data (Technical Success and Safety): Independently analyzed by the Angiography and Noninvasive Imaging Core Lab at University of California - Los Angeles. The number of experts is not specified.
• Adverse Events: Adjudicated independently by the Department of Neurology at the University of Southern California. The number of experts is not specified.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty certification) of the experts for both imaging analysis and AE adjudication are not explicitly detailed beyond their affiliation with known university medical departments/labs.

4. Adjudication Method for the Test Set

• Imaging Data: Independent analysis by a core lab (UCLA). No specific "2+1" or "3+1" consensus method is described, implying independent interpretation rather than a multi-reader consensus process for a single finding.
• Adverse Events: Independently adjudicated by a department (USC Neurology). Similar to imaging, a specific multi-expert consensus method (e.g., 2+1) is not explicitly stated.

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

• No, an MRMC comparative effectiveness study was not explicitly done to evaluate how human readers improve with AI vs. without AI assistance. The clinical study was a retrospective case series focused on device performance and safety with standard human intervention. The device is a mechanical assist device, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists interpreting images). Therefore, this type of MRMC study is not applicable to the Comaneci device's function.

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

• Not applicable. The Comaneci device is a physical, mechanical embolization assist device, not an algorithm. Its performance is inherently tied to human use in a medical procedure. Standalone performance for a device of this type would refer to bench testing (which was performed) or animal studies (which were performed), demonstrating the device's mechanical integrity and biological interaction. It does not relate to an algorithm's performance without human interaction.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for clinical outcomes (technical success and adverse events) was established through a combination of:
  • Independent analysis of imaging data (angiography) by a core lab for technical success (e.g., aneurysm occlusion, coil prolapse).
  • Independent adjudication of adverse events by a neurology department based on collected CRF data.
  • Patient follow-up data (up to 3 months post-procedure) to assess clinical abnormalities or sequelae related to events like coil prolapse.
  • For the purposes of this device, the "ground truth" concerning the clinical outcomes is defined by these independent expert evaluations and the observed clinical course.
• Animal Study: Ground truth was established by:
  • Angiographic evaluations at termination to assess blood flow, aneurysm filling, and coil presence.
  • Gross and histological evaluations (light microscopy, SEM) of tissue sections for injury, inflammation, and endothelial loss.
  • Clinical observation of animals (morbidity, thrombosis, infection, hemorrhage).

8. The Sample Size for the Training Set

• The document does not mention a "training set" in the context of device development or evaluation, as this pertains more to AI/machine learning models. For a physical medical device, development involves iterative design, bench testing, and animal studies, which collectively inform and "train" the design, but not in the sense of a data science training set. The clinical study was a retrospective data collection for validation, not a dataset used for iterative model training.

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

• As a "training set" in the data science sense is not explicitly mentioned or used for this mechanical device, the concept of establishing ground truth for it is not applicable here. The development and verification process relied on engineering principles, bench testing standards, animal models, and human clinical experience.

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