(20 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) 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 dc-airing and coil detachment. The HES prominer 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 junetion 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.
The provided document is a 510(k) premarket notification for the HydroCoil® Embolic System (HES). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria based on detailed performance studies with clinical outcomes in the way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving it, sample sizes for test/training sets, expert consensus details, or MRMC studies.
Instead, it states the following:
1. Table of Acceptance Criteria and Reported Device Performance:
- This information is not present in the document. The document states that "Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils is equivalent in performance to the predicate devices." However, it does not provide specific acceptance criteria or the numerical results of this performance testing.
2. Sample size used for the test set and the data provenance:
- This information is not present in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not present in the document.
4. Adjudication method for the test set:
- This information is not present in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not present in the document. The device in question is an embolization coil, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not present in the document. The device is an embolization coil, not an algorithm.
7. The type of ground truth used:
- This information is not present in the document.
8. The sample size for the training set:
- This information is not present in the document.
9. How the ground truth for the training set was established:
- This information is not present in the document.
In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, indications for use, design, materials, packaging, and sterilization. It does not provide the detailed performance study data, acceptance criteria, or ground truth establishment methods typically found in clinical trials or AI algorithm validation studies.
§ 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).