(37 days)
The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are 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 MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. 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 provided document contains information regarding the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). However, it focuses primarily on the regulatory submission and technical comparison to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly available in the provided text.
Here's an attempt to extract the information that is present and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides "Bench Test Summary" tables, which outline tests performed and their results. These represent acceptance criteria for the bench tests to demonstrate manufacturing quality and function. It does not provide acceptance criteria for clinical efficacy or safety, which would typically be part of a larger clinical study.
| Test | Acceptance Criteria (Implied by "met acceptance criteria") | Reported Device Performance |
|---|---|---|
| Visual Inspection | Product drawings | All test samples met the acceptance criteria and passed testing. |
| Pusher Resistance | Implied standard for digital multi-meter measurement (specific values not provided) | All test samples met the acceptance criteria and passed testing. |
| Simulated Use | Successful: • Introduction • Tracking inside microcatheter • Deployment • Microcatheter Movement • Detachment | All test samples met the acceptance criteria and passed testing. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for bench tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests are "bench tests," implying laboratory-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. (This would be more relevant for clinical ground truth, which is not described here).
4. Adjudication method for the test set
- Adjudication Method: Not specified. Bench tests typically involve direct measurement or observation against predefined specifications, often without peer adjudication in the way clinical studies do.
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
- MRMC Study: No, this document describes a regulatory submission for medical devices (coils) for neurovascular embolization, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related metrics are applicable or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is a medical device (coils) and not an algorithm.
7. The type of ground truth used
- Ground Truth Type: For the bench tests, the "ground truth" seems to be defined by engineering specifications, product drawings, and functional requirements for the device. For example, for "Visual Inspection," the ground truth is "product drawings."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document refers to physical device testing rather than machine learning algorithm training.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Summary of Missing Information:
The provided document is a 510(k) summary for a neurovascular embolization device. It details the device's description, indications for use, comparison to a predicate device, and bench testing results. It does not contain information about clinical trials, AI performance, or studies involving human readers or expert-established ground truth in a clinical context. The "acceptance criteria" and "performance" discussed are limited to manufacturing and functional bench tests.
§ 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).