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The Penumbra LP 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 LP Coil System is comprised of the Penumbra LP Coil, a platinum embolization coil attached to a composite delivery pusher with a radiopaque positioning marker and the Penumbra LP Coil Detachment Handle.

The coil/delivery pusher is packaged separately from the Penumbra LP Coil Detachment Handle. Penumbra LP Coil includes the following coil configurations:

• Ruby Coil LP ●
• Packing Coil LP ●
• PTC Coil LP ●
• Helical Coil LP ●
• Hybrid Coil LP ●

The provided text is a 510(k) summary for the Penumbra LP Coil System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through an independent study with a defined ground truth, a test set, or expert adjudication.

Therefore, many of the requested data points (sample size of test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of submission.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes bench-top testing performed to evaluate the physical and mechanical properties of the subject device and demonstrate substantial equivalence to the predicate device. For each attribute, the "Specification" acts as the acceptance criteria, and the "Results" indicate the device met these criteria.

Additionally, the document states:

• Biocompatibility Testing: The Penumbra LP Coil System was determined to be biocompatible according to the requirements of ISO 10993-1. Specific tests for the Detachment Pusher (Cytotoxicity, Hemocompatibility) and Introducer Sheath (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Material-Mediated Pyrogenicity) were performed.
• Sterilization Testing: The device was tested to be sterile using identical acceptance criteria and testing methods as the predicate device in accordance with ISO 11135 and ISO 10993-7. The Sterilization Assurance Level (SAL) requirement is ≥10-6.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or images for an AI/CAD/software device. The tests performed are bench-top mechanical, chemical, and biological evaluations. The sample size for each bench-top test is not explicitly mentioned.

Data Provenance: Not applicable in the context of clinical data for this type of submission. The data is from laboratory testing (bench-top, biocompatibility, sterilization).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a physical medical device (embolization coil system), not a diagnostic device relying on expert interpretation of images or clinical data. Ground truth, in this context, refers to established engineering specifications and international standards (e.g., ISO 10993-1, ISO 11135, ISO 10993-7).

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The "Pass" results for bench-top tests indicate compliance with predefined engineering specifications.

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

Not applicable. This is a physical medical device; it is not an AI/CAD/software device intended to assist human readers.

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

Not applicable. This is a physical medical device; it is not a standalone algorithm.

7. The Type of Ground Truth Used

For the bench-top testing, the "ground truth" or reference for evaluating performance was engineering specifications, product specifications, and relevant international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 and ISO 10993-7 for sterilization).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set.

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The Penumbra LP 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 LP Coil consists of a Coil Implant attached to a Detachment Pusher, both contained within a Sheath. The Detachment Pusher comprises a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT), and a pull wire. A Detachment Handle (packaged separately) is used to detach the Coil Implant from the Detachment Pusher. The LP Coil is designed for endovascular embolization in the neuro and peripheral vasculature. Intended users for this device are physicians who have received appropriate training in interventional radiology. The LP Coil is a line extension to the Penumbra Smart Coil System (hereinafter referred to as Smart Coil) that uses the existing Sheath, Detachment Pusher, and Detachment Handle from the Smart Coil. This line extension includes two configurations:

• Ruby LP .
• Finish LP ●

This document describes the Penumbra LP Coil System, a neurovascular embolization device. The information provided outlines the device's indications for use, its classification, and a comparison to predicate and reference devices, as well as a summary of non-clinical data.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The provided text does not specify the exact sample sizes used for each individual bench-top test (Dimensional/Visual Inspection, Friction Testing, Fatigue Resistance, Simulated Use Flow Model Testing, Distal System Tensile Test, and Sterilization Testing). It generally states "all tests passed," implying that the tested samples met the criteria.

The data provenance is from non-clinical data (bench-top testing and sterilization testing) performed by Penumbra, Inc. in Alameda, CA, USA. The studies are prospective in nature, as they involve actively testing the device against predefined specifications.

3. Number of Experts and Qualifications for Ground Truth:

This document describes a premarket notification for a medical device (510(k)) based on substantial equivalence, primarily supported by non-clinical bench-top and sterilization testing. The concept of "ground truth established by experts" in the context of clinical interpretation, such as by radiologists, is not directly applicable here.

For non-clinical tests, the "ground truth" is defined by the engineering specifications and industry standards (e.g., ISO 11135, ISO 10993-7), which are set by qualified engineers and scientists during the design and development process. The testing itself is conducted by trained technicians or engineers to verify adherence to these established specifications. The document doesn't specify the number of individuals involved in setting these specifications.

4. Adjudication Method for the Test Set:

For the non-clinical tests described, a formal adjudication method like "2+1" or "3+1" is typically not used, as these are more common in clinical studies involving interpretation of data by multiple human observers.

Instead, the results are likely determined by direct measurement against objective criteria and specifications. A "Pass" or "Fail" outcome is generally determined by whether the device performance falls within the predefined acceptable range for each attribute. Any discrepancies during testing would likely be handled through standard quality control and engineering review processes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

The document discusses a non-clinical substantial equivalence determination for a physical medical device (coils) and does not involve AI or human interpretation of images requiring an MRMC study. The comparison is between the subject device and predicate devices based on design, materials, and non-clinical performance characteristics.

6. Standalone Performance Study:

Since this is a physical medical device and not an algorithm/AI system, the term "standalone performance" in the context of an algorithm's performance without human-in-the-loop is not applicable. The "standalone performance" of the device is demonstrated by the bench-top and sterilization testing results, which show the device's intrinsic mechanical and material properties meet specifications.

7. Type of Ground Truth Used:

The ground truth used for this study is:

• Engineering Specifications and Design Requirements: For dimensional/visual inspection, friction testing, fatigue resistance, distal system tensile test, and overall simulated use performance. These specifications define the expected physical and mechanical properties.
• International Standards: For sterilization testing (ISO 11135 for sterilization, ISO 10993-7 for ethylene oxide residuals). These standards define acceptable levels and methods for sterilization.

8. Sample Size for the Training Set:

Not applicable. This document describes non-clinical testing for a physical medical device. It does not involve machine learning or AI, and therefore there is no "training set" in the computational sense. The "training" in the context of manufacturing would involve calibrating machinery, training personnel, and establishing processes, which are part of good manufacturing practices, but not a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it. The "ground truth" for the device's design and manufacturing is established through engineering design processes, risk analysis, and adherence to relevant industry standards and regulations.

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