(400 days)
The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The FX Detachable Coil System consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a handheld mechanical FX detachment actuator which facilities the release of the coil from the delivery pusher tip. The Nexus version of the FX Detachable coil is enlaced with absorbable polymer microfilaments. The FX Detachment Actuator is sold separately.
The provided text describes a 510(k) submission for the FX Detachable Coil System, focusing on its substantial equivalence to predicate devices rather than a study demonstrating performance against specific acceptance criteria for standalone device performance. The study described is primarily a set of bench tests designed to show that the new device performs similarly to or meets the same engineering specifications as the predicate devices.
Therefore, many of the requested categories, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, and details on training sets for AI algorithms, are not applicable or cannot be extracted from this document, as it does not describe a clinical trial or an AI/ML-based device performance study.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various bench tests and states that the device "Met established criteria" for each. The specific numerical acceptance criteria themselves are not provided in this summary.
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Dimensional & Visual Analysis | Met established criteria |
| Force Transfer | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | Met established criteria |
| Reliability After Fatigue & Premature Detachment | Met established criteria |
| Tensile Strength of Delivery Pusher | Met established criteria |
| Tensile Strength at Detachment Zone | Met established criteria |
| Particulate Generation - Adjusted Particles / 1 mL | Met established criteria |
| Delivery Pusher Distal Tip Buckling | Met established criteria |
| Delivery Pusher Distal Stiffness Profile | Met established criteria |
| Packaging Integrity | Met established criteria |
| Detachment Actuator Life Cycle and Reliability | Met established criteria |
| Time and Reliability of Detachment | Met established criteria |
| Radiopacity | Met established criteria |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document details bench tests, which often involve a specific number of units tested per criterion, but these numbers are not disclosed.
- Data Provenance: Not applicable in the context of a clinical test set. The data originates from internal engineering bench testing performed by the submitting company (Micro Therapeutics, Inc. / ev3 Neurovascular). It is not retrospective or prospective clinical data, nor does it refer to country of origin in that sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The "ground truth" for bench tests is typically established by engineering specifications, validated test methods, and industry standards, not by clinical experts.
4. Adjudication method for the test set
- Not applicable. Bench tests are typically pass/fail against predefined criteria, not subject to expert adjudication in the same way clinical image reviews would be.
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 applicable. This is not an AI/ML device, and no MRMC study was performed or described. This submission is for a physical medical device (neurovascular embolization coil).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device. "Standalone performance" here refers to the physical device's performance as measured by the bench tests.
7. The type of ground truth used
- The "ground truth" for the bench tests is based on established engineering specifications, validated test methodologies, and material standards, presumably benchmarked against the predicate devices or industry requirements.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and no "training set" in that context is used. The development of the device would involve engineering design and verification, not machine learning training.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm is involved.
§ 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).