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The Penumbra Coil System is intended for the embolization of:

• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

The Penumbra Coil System consists of the following components, which are sold separately:

• Standard Complex Coils attached to detachment pusher
• Soft Complex Coils attached to detachment pusher
• Soft Coils attached to detachment pusher
• Curve Extra Soft Coils attached to detachment pusher
• Curve Complex Extra Soft Coils attached to detachment pusher
• Detachment Handle

The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.

The Penumbra Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.

The provided text is a 510(k) Summary for the Penumbra Coil System/Penumbra Coil 400. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific clinical acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in the prompt regarding a study that proves the device meets acceptance criteria, an effects size for MRMC studies, or detailed information about ground truth establishment for a test set. This type of information is typically found in clinical trial reports or performance study reports, which are not part of a 510(k) summary focused on substantial equivalence.

However, based on the non-clinical data presented, I can extract and present the acceptance criteria for those tests and their reported performance.

Non-Clinical Acceptance Criteria and Reported Device Performance

For the non-clinical tests, the "acceptance criteria" are implied by the expected outcome for a safe and effective medical device, and the "reported device performance" are the results obtained.

Information Not Available in the Provided Text:

• Sample size used for the test set and the data provenance: The document is a 510(k) summary demonstrating substantial equivalence for a labeling change. It does not contain information about a test set for clinical performance. The non-clinical tests were conducted using statistical sampling methods as required by Penumbra Design Control procedures, but specific sample sizes are not detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set for performance is described.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical implant, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the biocompatibility and design verification tests, the "ground truth" is established by the validated methods themselves and the specified acceptance criteria for each test (e.g., "non-toxic," "non-irritant," "passed successfully").
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

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