(29 days)
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Microcoil Delivery System consists of (1) An embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile). (2) An Connecting Cable ("CCB") (3) A Detachment Control Box ("DCB")
The provided documentation is a 510(k) summary for the Micrus Microcoil Delivery System and related FDA correspondence. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.
Therefore, many of the requested categories (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted and a clear indication of what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices in terms of intended use, design, material, method of construction, and dimensions. | The modification (new Detachment Control Box - DCB) has not altered the fundamental technology of the sponsor's predicate device. Based on design, materials, function, intended use comparison with currently marketed device, and non-clinical testing, the new DCB is deemed substantially equivalent to predicate devices in safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. This submission relies on "non-clinical testing" and comparison to a predicate device, not a clinical study with a test set in the context of AI/ML.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The ground truth concept as typically applied to AI/ML devices for diagnostic accuracy is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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 Done?: No. This type of study is not relevant for this device submission which focuses on substantial equivalence of a physical medical device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm. The submission is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: For this submission, the 'ground truth' is implicitly the established safety and effectiveness profile of the legally marketed predicate devices (Micrus Microcoil Delivery System, 510(k) K002056 and K031578). The new device is shown to be substantially equivalent to these.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device trained on data.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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).