Search Results

The Penumbra Coil System is indicated 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:

• . Complex Standard Implantable Embolization Coils attached to detachment pusher
• . Complex Soft Implantable Embolization Coils attached to detachment pusher
• . J Soft Implantable Embolization Coils attached to detachment pusher
• . Curve Extra Soft Implantable Embolization 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 Embolization 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.

This document describes the Penumbra Coil System, which is an embolization coil system. The information provided is a 510(k) summary for premarket notification to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than the specific performance metrics of a diagnostic AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to this type of device and submission. The document primarily details biocompatibility and design verification tests, which are typical for medical implants.

However, I can extract information relevant to the acceptance criteria and study proving it, as available from the provided text.

Acceptance Criteria and Reported Device Performance

Explanation of the Study and its Findings:

The "study" presented here is a summary of non-clinical data for a 510(k) premarket notification. The primary goal is to demonstrate "Substantial Equivalence" to a legally marketed predicate device (Guglielmi Detachable Coil - GDC™). This is achieved by showing that the Penumbra Coil System has comparable indications for use, fundamental technological characteristics (materials, sterilization), and meets established safety standards through various testing.

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

   • Biocompatibility: The specific sample sizes for each test (e.g., number of animals for in-vivo tests, number of cells for in-vitro tests) are not provided in this summary. However, the tests were conducted "in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices)" and "pursuant to 21 CFR, Part 58, Good Laboratory Practices," implying standard and appropriate sample sizes were used for these types of studies. The provenance is internal testing conducted according to international standards for medical devices.
   • Design Verification (Bench-Top Testing): The document states "All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures." Specific sample sizes for each physical/mechanical test are not provided, but it notes "all sizes" for Dimensional/Visual Inspection. The provenance is internal bench-top testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert interpretation of results. The "ground truth" for biocompatibility tests is the biological response, and for design verification, it's the physical/mechanical properties measured against engineering specifications.

3. Adjudication method for the test set: Not applicable for this type of device testing. Results are typically objectively measured against pre-defined performance specifications (e.g., "non-toxic," "non-irritant," "passed successfully").

4. 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: Not applicable. This device is an embolization coil, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.

6. The type of ground truth used:

   • Biocompatibility: Biological responses (e.g., cellular toxicity, systemic effects, sensitization, pyrogenicity, hemocompatibility, tissue reaction to implantation) as defined by ISO 10993 standards and measured by laboratory tests.
   • Design Verification: Established engineering specifications, physical and mechanical properties, and performance benchmarks for the device components.

7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device