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The HydroCoil® Embolic System (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 HydroCoil® Embolic System (HES) consists of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The HES coils are platinum helical coils with an outer layer of a hydrophilic polymer. The polymer material is a cross-linked copolymer of acrylamide and acrylic acid. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heatshrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to the treatment site on the delivery pusher through standard neurointerventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.

Below is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Acceptance Criteria and Device Performance

The provided document describes the HydroCoil® Embolic System (HES), an embolization coil. The core of its acceptance for market entry (510(k) clearance) is based on its substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided text does not specify a "test set" in the context of a clinical study with real patient data. The evaluation is based on "performance testing" demonstrating equivalence to predicate devices. This typically refers to

• Bench testing: In-vitro mechanical, material, and functional tests.
• Animal studies: Pre-clinical evaluations of safety and performance in an animal model, if required.
• Comparison to existing clinical data from predicate devices: This is implied by the substantial equivalence claim, rather than new clinical data for this specific modified device.

Therefore, details like country of origin or whether it was retrospective/prospective are not applicable as a separate clinical "test set" for this specific device's clearance is not described. The substantial equivalence relies on the established safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided as the clearance is based on substantial equivalence and "performance testing," not a clinical study requiring expert ground truth assessment of patient cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided as a clinical test set requiring adjudication is not described.

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:

This is not applicable. The device (HydroCoil® Embolic System) is a medical implant (embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

This is not applicable. The device is an embolization coil, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the purpose of this 510(k) clearance, the "ground truth" for the device's acceptance is based on:

• Established safety and effectiveness of predicate devices: The primary ground truth is that the predicate devices (HydroCoil® Embolic System and Matrix™ Stretch Resistant Detachable Coils) have already been deemed safe and effective and are legally marketed.
• Performance testing (bench and potentially animal studies): These tests likely compared the new device's physical properties, mechanical performance, and perhaps immediate biological interactions to specifications or established performance of the predicate devices.

8. The sample size for the training set:

This information is not provided and is not applicable in the context of this device's regulatory submission, as it is not an AI/machine learning product requiring a training set.

9. How the ground truth for the training set was established:

This information is not provided and is not applicable for the reasons mentioned above.

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