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POD is indicated for the endovascular embolization of:

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

The Penumbra Occlusion Device (POD), including the subject device, is a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. It is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. It is also intended for arterial and venous embolization in the peripheral vasculature. The POD System should only be used by physicians who have received appropriate training in interventional techniques.

The POD System consists of the following components:

• Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer . Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
• . Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
• . Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
• . Detachment Handle: The Detachment Handle is packaged separately. It is intended for use in multiple coil detachments performed during a single procedure

The Penumbra, Inc. POD Packing Coil is a Class II neurovascular embolization device. The testing described for this device is primarily "bench-top testing" and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device, the POD System (K141134). No clinical studies or AI/ML components are mentioned in the provided text.

Here's an analysis based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily shows specifications for various physical and mechanical properties, and the results confirm that these specifications were met (100% Pass).

In addition, biocompatibility tests were performed on the predicate and reference devices, with the following results:

2. Sample size used for the test set and the data provenance:

• Bench-top testing: The sample size for the bench-top tests is not explicitly stated as a number. For "Dimensional/Visual Inspection," "Fatigue Resistance," "Torsional Resistance," "Friction," and "Distal System Tensile Test," the result is "100% Pass," which implies all units tested passed, but the number of units is not given. For "Simulated Use Flow Model Testing," the result is also "100% Pass," but again, the number of simulations/devices tested is not specified.
• Biocompatibility testing: The biocompatibility testing was performed on the predicate and reference devices. The sample sizes for these tests are not provided in this summary.
• Data provenance: Not explicitly stated, but bench-top testing is typically conducted in a laboratory setting, and biocompatibility studies adhere to GLP (Good Laboratory Practices), implying controlled experimental conditions rather than patient-derived data directly.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a physical medical device, and its performance evaluation relies on objective measurements and established engineering and biocompatibility standards, not expert-derived ground truth from interpreting medical images or clinical outcomes in the context of an AI/ML study.

4. Adjudication method for the test set:

• Not applicable. As noted above, this involves objective measurements and standard test protocols for a physical device, not subjective interpretation requiring adjudication among experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. The document describes bench-top and biocompatibility testing for a physical device. There is no mention of an AI component or a comparative effectiveness study involving human readers.

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

• No. This is a physical medical device, not an algorithm or AI model.

7. The type of ground truth used:

• Bench-top testing: The "ground truth" here is defined by established engineering specifications and performance standards for medical devices (e.g., dimensional tolerances, mechanical strength, resistance to fatigue).
• Biocompatibility testing: The "ground truth" is determined by well-established international standards and guidelines for biological evaluation of medical devices (EN ISO 10993-1) and specific test methodologies (e.g., ISO Elution Test, Magnusson-Kligman Method, ASTM methods, USP tests) that define what constitutes "non-toxic," "non-irritant," etc. These are objective scientific measurements and observations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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