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The Retracta" Detachable Embolization Coil is intended for arterial and venous embolization in the peripheral vasculature.

The Retracta." Detachable Embolization: Coil consists of a fibered embolization coil constructed of platinum and a detachable delivery system. The implant consists of coiled wire and synthetic fibers which increase thrombogenesis. Embolization fibers are spaced along the coil until nearly the proximal tip. The fibers extend perpendicular to the long axis of the coil. Once deployed, the coil forms a curl, which varies in curl diameter and spacing. The embolization coil is delivered to the vasculature by means of a coll delivery wire.

The provided text describes a 510(k) submission for the Retracta" Detachable Embolization Coil. This submission focuses on demonstrating substantial equivalence to predicate devices through technical and performance testing, not on clinical effectiveness studies involving human readers or sophisticated AI algorithms. Therefore, much of the requested information regarding AI performance, human expert evaluation, and MRMC studies is not applicable to this document.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of units tested) for each of the performance tests. The data provenance is not explicitly mentioned, but as this is a device submitted to the FDA, it is presumed to be laboratory testing conducted by the manufacturer (Cook Incorporated, based in Bloomington, IN, USA) to U.S. regulatory standards. These are retrospective engineering/bench tests, not clinical data.

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)

This information is not applicable. The tests performed are engineering and material science tests (tensile strength, biocompatibility, corrosion, etc.) and do not require expert human interpretation of medical images or conditions to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. The tests are objective, quantifiable measurements against predetermined engineering specifications, not evaluations requiring adjudication by multiple human experts.

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. This submission is for a physical medical device (embolization coil), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. This submission is for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests was defined by predetermined acceptance criteria based on regulatory guidance (FDA Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (2004)) and industry standards (e.g., ISO 10993-1 for biocompatibility). These criteria are objective, measurable thresholds for physical properties and performance characteristics.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" for such a device would be the design and manufacturing process iterative improvements.

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set in the context of AI, there's no ground truth established for one. The "ground truth" for the device design would be established through engineering principles, material science, and adherence to performance specifications derived from regulatory and clinical needs.

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