Search Results

The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.

This device is not intended for coronary or neurovascular use.

The EMBOLD™ Fibered Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable fibered embolic coil. The device is compatible with 0.021 inch to 0.027 inch microcatheters. In addition, the device features a modified mechanical detachment mechanism consisting of an inner pull wire connecting the coil and delivery wire coupler arms, activated by the user through a proximal laser etched outer wire perforation. The delivery wire design allows the coil to be fully advanced, retracted, and deployed prior to final placement.

The EMBOLD™ Fibered Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.

This document, a 510(k) Summary, describes the submission of the EMBOLD™ Fibered Detachable Coil System for FDA clearance. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML algorithm.

The document is for a medical device (a vascular embolization device), not an AI/ML diagnostic or therapeutic system. Therefore, the specific details requested in the prompt, such as test set sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information, are not relevant to this type of device submission and are not present in the provided text.

Instead, the document focuses on:

• Device Description: What the EMBOLD™ system is, its components, and specifications (e.g., coil dimensions, materials).
• Intended Use/Indications for Use: The medical purpose of the device (obstructing/reducing blood flow in peripheral vasculature).
• Predicate Device: Identification of a legally marketed device (Interlock™ Fibered IDC™ Occlusion System) to which the new device is compared for substantial equivalence.
• Comparison of Technological Characteristics: A detailed table comparing the new device to the predicate device in terms of features, materials, and other specifications.
• Non-Clinical Performance Testing: A statement that biocompatibility, bench testing, and an acute GLP animal study were performed to support substantial equivalence.

Without an AI/ML component, there's no "algorithm performance" to report in the way the prompt specifies. The "acceptance criteria" for a traditional medical device are typically related to safety, functionality, material properties, and performance in non-clinical (bench and animal) testing to demonstrate it performs as intended and is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document describes a traditional medical device clearance, not an AI/ML-driven one.

Ask a specific question about this device