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The HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.

The HydroSoft and HydroSoft Plus Embolization Coils Systems also are 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 embolization in the peripheral vasculature.

The HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are platinum embolization coils with an inner hydrogel core, and a V-TrakTM Delivery Pusher.

The provided document is a 510(k) premarket notification for a medical device called "HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not describe, nor does it require for a 510(k) submission, the specific information requested about acceptance criteria, a study proving device performance against such criteria, sample sizes, ground truth establishment, or clinical effectiveness studies in the format typically associated with a new device approval.

Instead, the submission focuses on comparing the new device to a predicate device (HydroCoil® Embolic System with (HES) with the HES-HC-HS (10) Coils (K070656)) to establish substantial equivalence based on material, design, and intended use. The performance attributes mentioned would typically refer to bench testing or animal studies demonstrating similar functional characteristics, rather than human clinical trials with performance metrics for an AI/algorithm-driven device.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's an attempt to address the request based on the available information, noting where information is not present:

Acceptance Criteria and Study for K080666: HydroSoft® and HydroSoft Plus Embolization Coil Systems

This 510(k) submission establishes substantial equivalence for the HydroSoft® and HydroSoft Plus Embolization Coil Systems to a predicate device (HydroCoil® Embolic System, K070656). The evaluation does not involve acceptance criteria or a study design in the context of an AI/algorithm-driven device's performance against clinical metrics. Instead, it relies on demonstrating similar technical and performance attributes to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria or detailed numerical performance metrics for the device, as it is focused on establishing substantial equivalence based on similarities to a predicate device, not on proving de novo clinical efficacy against predefined thresholds.

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

• Sample Size (Test Set): Not applicable or not specified. A clinical "test set" in the context of a new AI algorithm's performance is not part of this 510(k) submission for an embolization coil.
• Data Provenance: Not applicable or not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or not specified. Ground truth establishment by experts for a test set is relevant for AI/diagnostic algorithms, not for physical medical devices in a 510(k) substantial equivalence submission.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified.

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

• MRMC Study Done: No. This type of study is typically conducted for diagnostic devices (e.g., imaging software) to assess reader performance with and without AI assistance. This document describes a physical neurovascular embolization coil.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No. This is not an AI/algorithm device.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of an AI/algorithm device. For this physical device, the "ground truth" for demonstrating substantial equivalence lies in comparing its material composition, design, and intended use against the legally marketed predicate device, and ensuring that any differences do not raise new questions of safety or effectiveness. This is implicitly established through engineering specifications, material testing, and a comparison of intended uses.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable or not specified. There is no AI algorithm being trained.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment (Training Set): Not applicable.

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