Search Results

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.

Ask a specific question about this device

The HydroFrame HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula. 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 embolization in the peripheral vasculature.

The HydroFrame coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop with miller hydroget core. he a V-Trak™ MCS delivery pusher via a polymer fillament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. The proximal end is niscreed into nell onecry powered. Costroller Controller.

This document describes the HydroFrame - HydroCoil Embolic System (HES), a neurovascular embolization device. The information provided is from a 510(k) summary (K090357) for FDA clearance. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to demonstrate substantial equivalence to previously cleared predicate devices, not a clinical trial with specific performance metrics like sensitivity/specificity.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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

The document describes bench testing, which typically does not involve human subjects or clinical data. The "test set" in this case would refer to the physical units of the HydroFrame coils subjected to the various bench tests. The specific sample sizes for each test are not provided in this summary.

The data provenance is MicroVention, Inc., Aliso Viejo, California, U.S.A. The data is from prospective bench tests performed by the manufacturer to demonstrate the device's physical and functional properties.

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

This question is not applicable to the type of testing described. Bench testing is a physical verification process against established engineering and design specifications. It does not involve medical experts establishing "ground truth" in the way clinical studies do (e.g., diagnosing a condition). The "ground truth" for these tests would be the pre-defined engineering specifications and performance targets for each test, which are determined by the manufacturer based on their design requirements and comparison to predicate devices.

4. Adjudication method for the test set

This is not applicable to bench testing as described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image review where multiple human readers are involved in making subjective assessments or diagnoses, and their disagreements need to be resolved. Bench tests involve objective measurements and comparisons against defined criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical implant (an embolic coil), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance does not apply.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the bench tests would be the established engineering specifications, design parameters, and performance criteria for each test (e.g., specific dimensions, tensile strengths, detachment forces, gel expansion rates). These criteria are derived from the device's design, manufacturing standards, and the performance characteristics of its predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this device's testing, as it is a physical product and not an AI/machine learning model.

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

This question is not applicable for the same reason as point 8.

Ask a specific question about this device