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The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HydroFrame coils in the HydroCoil Embolic System (HES) consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment.

This document describes the HydroCoil Embolic System (HES), specifically the HydroFrame® 10 for neurovascular and peripheral vascular embolization.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the nature of the "Result" column, which uniformly states "All test samples passed testing", "Non-toxic", "No sensitizer response", "Non-irritant", "Non-hemolytic", "No adverse effect on coagulation time", "Non-pyrogenic", and "Negative response for mutagenicity". The specific quantitative thresholds for "passing" are not explicitly stated in this summary but would be detailed in the full test reports (e.g., PDH-HFRM-ATP for visual inspection).

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

• Sample Size: The document repeatedly states "All test samples passed testing" but does not specify the precise number of samples used for each test. This information would typically be found in the detailed test protocols or reports referenced (e.g., PDH-HFRM-ATP).
• Data Provenance: The tests performed are pre-clinical bench and biocompatibility laboratory tests. The country of origin of the data is not explicitly stated, but the company, MicroVention, Inc., is based in Tustin, California, USA, suggesting the testing was likely conducted in the USA or by labs compliant with US regulatory standards. Since these are in-vitro and animal tests, they are inherently prospective as they are specifically conducted for this submission.

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

This document describes technical and biological tests, not studies requiring expert human interpretation of medical images or conditions to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists, pathologists) does not apply here. The "ground truth" for these tests is established by the predefined pass/fail criteria and objective quantitative measurements of the device's physical and biological performance against established standards (e.g., ISO 10993 series for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus processes among multiple human reviewers for clinical endpoints or image interpretation. The tests described are objective performance and biocompatibility assays with predefined pass/fail criteria.

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

No MRMC comparative effectiveness study was mentioned or performed. The document focuses on demonstrating substantial equivalence through technical and biocompatibility performance data, not through human reader performance with or without AI assistance.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Not applicable. The HydroCoil Embolic System is a physical medical device (coils for embolization), not an algorithm or AI software. Therefore, an "algorithm only" performance study is not relevant. The performance evaluated is the device's physical and biological function.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Quantitative Bench Test Specifications: Predefined engineering and performance specifications for physical characteristics like dimensions, forces, and material properties.
• Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological response to medical devices. These standards define the acceptable biological reactions (e.g., non-toxic, non-irritant).

8. Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this type of medical device.

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