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Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Treatment of cerebral aneurysms can be performed either by surgical clipping or endovascular techniques (e.g., embolization coils). Endovascular methods to embolize intracranial aneurysms with implantable platinum embolization coils were developed in the 1970s. Embolization coils including the MicroVention MCS and HES products are now widely used to treat all aneurysms.

The MCS consists of an implantable coil made of bare platinum alloy (Platinum/Tungsten), and the HES consists of an implantable coil made of the same platinum alloy with a hydrogel inner core. The coil is attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment. The V-Grip is packaged and sold separately.

The modified MCS and HES devices are substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

The provided Special 510(k) K132952 describes the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The submission primarily focuses on the substantial equivalence of these devices to previously cleared predicate devices, with a minor modification related to the V-Trak Advanced delivery pusher. As such, the study summarized is a design verification and validation bench test, along with biocompatibility testing, rather than a clinical study involving human subjects or algorithm performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the individual bench tests. It refers to "design verification and validation bench tests," which typically involve a specified number of units per test to ensure statistical significance or manufacturing quality. However, the exact number of coils or components tested is not provided.

The data provenance is pre-clinical bench testing conducted in a lab environment. There is no information regarding country of origin for this testing, but it can be inferred to be from the manufacturer, MicroVention, Inc., located in Tustin, California, U.S.A. This is retrospective in the sense that it's performed on manufactured devices for regulatory submission.

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

This information is not applicable as the reported tests are physical and functional bench tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "acceptance criteria" are based on engineering specifications and established industry standards (e.g., ISO for biocompatibility).

4. Adjudication Method for the Test Set

This is not applicable as there were no subjective expert assessments that would require adjudication. The tests were objective measurements against defined acceptance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted and is not described in this submission. This type of study would typically be performed for devices involving human interpretation (e.g., imaging devices with AI assistance), which is not the case for this neurovascular embolization device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was not conducted and is not described. This submission is for a physical medical device (coils and delivery system), not a software algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the bench tests was based on:

• Engineering Specifications: For visual inspection and measurements ("Per product drawing").
• Performance Ratings: Based on simulated use scenarios, likely defined by internal engineering or clinical experts within the company to assess deployment, repositioning, and detachment.
• Physical Properties/Standards: For pusher resistance and detachment zone tensile strength, these refer to measurable physical properties with specific numerical ranges.
• International Standards (ISO 10993 series): For biocompatibility testing, compliance with these established standards serves as the ground truth for biological safety.

8. Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device, not a machine learning model, so there is no "training set."

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

This is not applicable as there is no training set for a machine learning model.

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