(26 days)
The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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 HydroSoft coils consist of an implant made of plantinum alloy with an inner hydrogel core. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-TrakTM delivery pusher via a polymer filament. 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. The implant segment detaches upon activation of the Detachment Controller.
The HyperSoft coils consist of an implant coil made of platinum alloy. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher via a polymer filament. 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. The implant segment detaches upon activation of the Detachment Controller.
The provided text describes a 510(k) summary for the HydroCoil Embolic System - HydroSoft and MicroPlex Coil System - HyperSoft, which are neurovascular embolization devices. The submission primarily focuses on establishing substantial equivalence to predicate devices through bench testing. There is no clinical study described in this document that would involve human subjects, data analysis for performance metrics relevant to AI/diagnostic devices, or the establishment of ground truth by medical experts.
Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and AI performance cannot be answered from the provided text. The document is essentially a regulatory filing proving that the new devices are functionally similar to existing ones based on engineering tests.
Here is an attempt to answer the questions based only on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Result from Bench Testing) |
|---|---|
| Simulated Use (Functionality) | Met established criteria |
| Detachment Test (Functionality) | Met established criteria |
| Detachment Zone Tensile (Strength) | Met established criteria |
| Advancement/Retraction Force (Handling) | Met established criteria |
| Coil to Coupler Weld Tensile (Strength) | Met established criteria |
| Spring Constant (Mechanical Property) | Met established criteria |
Note: The document states "Met established criteria" for each test. The specific numerical values or ranges for these criteria are not provided in this summary.
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The tests performed are bench tests on the device itself, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. The "ground truth" in this context refers to the defined engineering specifications or performance standards for the device's mechanical properties and functionality, not medical diagnoses established by experts.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication typically refers to the resolution of disagreements among experts when establishing ground truth for diagnostic studies. For engineering bench tests, failure to meet a criterion is generally unambiguous.
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 information is not applicable/not provided. This document describes a medical device (coils for embolization), not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This document pertains to a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
For the bench tests, the "ground truth" was likely predetermined engineering specifications, design requirements, and performance standards for the device's various mechanical and functional aspects.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this device's regulatory submission, as it's not an AI or machine learning product.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.
§ 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).