(25 days)
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System 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 Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
The provided document describes the Optima Coil System, a neurovascular embolization device. The submission is a Special 510(k) to obtain market clearance for a modified device, primarily involving the addition of new sizes (coil OD, length) and combinations of primary wind and filar diameters. The document asserts that the modified device is substantially equivalent to the predicate device (Optima Coil System K172390).
Here's an analysis of the acceptance criteria and supporting study information:
1. A table of acceptance criteria and the reported device performance
| Testing Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and dimensional inspection | All samples must show no sign of visual physical damage and meet specified secondary diameter and length requirements. | Pass |
| Simulated Use | All samples must achieve a performance rating of 3 or greater for introduction, tracking, deployment, and repositioning. | Pass |
| Detachment | All samples must detach by the third attempt. | Pass |
| Detachment Zone tensile testing | All samples must meet a specified minimum tensile strength. | Pass |
| Stretch-resistance thread tensile testing | All samples must meet a specified minimum tensile strength. | Pass |
| Usability | All samples must meet established clinical performance metrics in the benchtop model. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for each test set. It repeatedly mentions "All samples," suggesting that a representative number of devices were tested for each criterion.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the types of tests conducted (bench testing, simulated use), it is safe to infer that this is prospective bench testing data conducted by the manufacturer (Balt USA, LLC) as part of their design verification and validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes a 510(k) submission for a physical medical device (embolization coils) and the performance data presented is from bench testing. The "ground truth" here is defined by engineering specifications and objective measurements (e.g., visual inspection, dimensional requirements, tensile strength, detachment attempts, performance rating for simulated use). Human expert evaluation for establishing ground truth in the way it's typically understood for AI/diagnostic studies (e.g., radiologists interpreting images) is not relevant for this type of device and testing.
4. Adjudication method for the test set
This section is not applicable for the same reasons as point 3. Bench testing of a physical medical device does not typically involve adjudication among human experts to establish ground truth. The acceptance criteria are objective measurements and pass/fail results based on predefined engineering limits.
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 section is not applicable. The device described is a neurovascular embolization coil system, not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical implant (embolization coils) and a delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the test results in this document is established by engineering specifications and quantifiable physical properties. This includes:
- Dimensional requirements: For secondary diameter and length.
- Visual inspection criteria: For physical damage.
- Performance ratings: For introduction, tracking, deployment, and repositioning in simulated use. These ratings would be based on predefined operational standards and potentially expert observation during the simulated procedure.
- Objective detachment criteria: Detachment within a specified number of attempts.
- Minimum tensile strength values: For detachment zone and stretch-resistance thread.
- Established clinical performance metrics: For usability in the benchtop model, likely reflecting real-world performance expectations.
8. The sample size for the training set
This section is not applicable. The device is a physical medical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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).