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The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is 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 HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The RD11-006 HES is a line extension which is substantially the same as the predicate devices (K070656, K080666, K091641). The implantable coil portion of both the predicate and the subject device is constructed from platinum alloy wire. The RD11-006 implantable coil is constructed of an oval-shaped platinum alloy wire, whereas the predicate devices are constructed of a round platinum alloy wire. All other materials and design features are the same for both the predicate and subject devices.

This document describes an FDA 510(k) summary for the HydroCoil Embolic System (HES) and asserts its substantial equivalence to a predicate device. It specifically focuses on a line extension with an oval-shaped platinum alloy wire, while the predicate devices used a round wire. There is no information in the provided text about a study (clinical or otherwise) that uses human readers, ground truth, or statistical analysis in the context of device performance. The entire submission is a declaration of equivalence based on bench testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document indicates that the acceptance criteria for the subject device are the "same criteria as predicate" for all bench tests. The reported device performance is that it "Met same criteria as predicate."

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

• Sample Size for Test Set: Not explicitly stated. The "Bench Test Summary" implies testing of device features, but the number of units tested is not provided.
• Data Provenance: The data is from bench testing, presumably conducted by the manufacturer, MicroVention, Inc., in the USA (Tustin, California). It is not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.

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

This is not applicable as the provided document details a 510(k) submission for a medical device (embolic coils) where the primary evidence presented is bench testing for substantial equivalence to a predicate device. There is no mention of a performance study involving human readers or experts to establish ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set:

This is not applicable for the reasons stated above. The evaluation is based on objective measurements from bench tests, not expert adjudication of diagnostic images or outcomes.

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:

This is not applicable. The device is an embolic coil, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device based on the information provided.

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

This is not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is related to the physical and mechanical properties of the device. The "acceptance criteria" for the bench tests effectively serve as the ground truth against which the subject device's performance is measured. This includes:

• Meeting dimensional specifications.
• Achieving established thresholds for mechanical properties (e.g., spring constant, weld tensile strength, advancement/retraction force).
• Performing as expected during simulated use (introduction, tracking, deployment, detachment).
• Exhibiting expected gel expansion characteristics.

These are objective, measurable characteristics that confirm functional equivalence to the predicate device.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of an embolic coil device submission for bench testing. The device is not learning from data.

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

This is not applicable for the reasons stated above.

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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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