Search Results

The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is 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.

The HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The modified HES is 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 text describes a Special 510(k) submission for a modification to the HydroCoil Embolic System (HES), specifically to the HydroFill component. This is a submission demonstrating substantial equivalence to a predicate device, not a de novo clearance or a novel device submission. Therefore, the "acceptance criteria" discussed are primarily related to bench testing demonstrating that the modified device performs similarly to the predicate device, rather than clinical efficacy endpoints. The study described is a series of bench tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k), the "acceptance criteria" are implied by demonstrating that the modified device met the same criteria as the predicate device in a series of bench tests. The reported performance is that all tests met these implied criteria.

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

The document does not specify the exact sample sizes (number of devices or tests performed) for each bench test. It only states that the modified device "Met same criteria as predicate." The data provenance is internal to MicroVention, Inc., and is derived from bench testing (presumably in a laboratory setting). It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in a clinical sense.

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

Not applicable. For bench tests demonstrating substantial equivalence, ground truth is established by engineering specifications, material properties, and performance benchmarks against the predicate device, not by expert clinical consensus.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is required to establish ground truth or resolve discrepancies. Bench tests rely on objective measurement and predefined engineering criteria.

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

Not applicable. This is a submission for a modification to a medical device (embolic coils), not an AI-powered diagnostic or therapeutic system. An MRMC study is not relevant to this type of device and submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests effectively consisted of the established performance and material specifications of the predicate device. The goal was to demonstrate that the modified device performed equivalently to these known specifications. This is an engineering/performance-based "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The data presented is from verification and validation bench testing of the physical device.

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

Not applicable. As noted above, there is no training set for this type of device.

Ask a specific question about this device