(98 days)
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) is based on electrical coil detachment. The HES consist of an implantable coil attached to a delivery system called a V-TRAK™ Delivery Pusher. The Delivery Pusher is a variable stiffness, stainless steel and tapered mandrel. Two silver electrical leads run along the outside of the mandrel from the proximal to the distal end. Platinum and stainless steel wires are wound around the distal end of the mandrel to form the electrical heater and provide kink-resistance. Two outer layers of PET tubing cover the distal end of the pusher assembly. A layer of polyimide tubing covers the proximal end. The proximal end of the HES coils incorporates a platinum coupler for attachment to the Delivery Pusher. A polyolefin elastomer filament is attached to the proximal end of the coil. This filament runs through the inner lumen of the coil coupler and is attached to the distal end of the Delivery Pusher.
The Delivery Pusher is powered by a hand-held, battery-powered V-GRIP™ Detachment Controller designed specifically for the HES. A gold-plated stainless steel connector at the proximal end of the Delivery Pusher is used to connect it to the Detachment Controller, The Detachment Controller is provided separately. The coil is delivered to treatment site on the Delivery Pusher through standard neuro-interventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the HES into the micro-catheter. Once the coil is deployed, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the Detachment Controller is turned on, the flow of current melts the polyolefin elastomer filament at the coupler/pusher junction resulting in coil detachment.
The provided text describes a 510(k) premarket notification for the HydroCoil® Embolic System (HES) and states that performance testing has demonstrated its equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot populate the table or answer most of the questions directly from the provided text.
Here's a summary of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is equivalent in performance to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided document.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified in the provided document.
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 specified in the provided document. This device is an embolization coil system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a medical device (embolization coil system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the provided document. The performance testing aimed to show equivalence to predicate devices, likely based on engineering performance metrics (e.g., detachment reliability, coil stability, mechanical properties) rather than diagnostic accuracy against a "ground truth" as typically understood in AI/imaging studies.
8. The sample size for the training set
- Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as this is a medical device, not an AI/ML algorithm.
Additional Information from the text:
- Device Name: HydroCoil® Embolic System (HES)
- Intended Use: Endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae; also for vascular occlusion of blood vessels within the neurovascular system and peripheral vasculature.
- Regulatory Status: 510(k) cleared, determined to be "substantially equivalent" to predicate devices.
- Nature of Study: Performance testing was conducted to demonstrate equivalence to predicate devices, focusing on operating principle, method of applications for use, design, materials, packaging, and sterilization.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).