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Temporary occlusion of intracranial blood verssels/aneurysms.

Permanent placement in the brain for occlusion of aneurysms.

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I am sorry, but the provided text from the FDA document (K972750) is a 510(k) clearance letter for the Taka Aneurysm Clip. This type of document primarily confirms that a medical device is substantially equivalent to a predicate device and is generally focused on regulatory approval rather than detailed performance study reports.

The document does not contain the information necessary to answer your request about acceptance criteria and the specifics of a study proving device performance, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Information on Multi-Reader Multi-Case (MRMC) studies or any effect sizes.
• Details about standalone algorithm performance.
• The type of ground truth used (pathology, outcomes data, etc.), or how it was established.
• Sample size for training sets.

The letter primarily covers:

• Confirmation of device clearance (K972750).
• Device name: Taka Aneurysm Clip.
• Regulation details (21 CFR 882.5200, Aneurysm clip, Class II).
• Indications for Use: Temporary occlusion of intracranial blood vessels/aneurysms, and permanent placement in the brain for occlusion of aneurysms.

To find the kind of detailed study information you're asking for, you would typically need to consult a different part of the 510(k) submission, such as the full premarket notification, or scientific publications related to the device, which are not included in this FDA clearance letter.

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