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The MicroPlex Coil System (MCS) and 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 MCS and 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 MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. 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 provided document contains information regarding the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). However, it focuses primarily on the regulatory submission and technical comparison to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly available in the provided text.

Here's an attempt to extract the information that is present and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Bench Test Summary" tables, which outline tests performed and their results. These represent acceptance criteria for the bench tests to demonstrate manufacturing quality and function. It does not provide acceptance criteria for clinical efficacy or safety, which would typically be part of a larger clinical study.

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

• Test Set Sample Size: Not explicitly stated for bench tests.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests are "bench tests," implying laboratory-based testing rather than patient data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. (This would be more relevant for clinical ground truth, which is not described here).

4. Adjudication method for the test set

• Adjudication Method: Not specified. Bench tests typically involve direct measurement or observation against predefined specifications, often without peer adjudication in the way clinical studies do.

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

• MRMC Study: No, this document describes a regulatory submission for medical devices (coils) for neurovascular embolization, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related metrics are applicable or mentioned.

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

• Standalone Performance: Not applicable, as this is a medical device (coils) and not an algorithm.

7. The type of ground truth used

• Ground Truth Type: For the bench tests, the "ground truth" seems to be defined by engineering specifications, product drawings, and functional requirements for the device. For example, for "Visual Inspection," the ground truth is "product drawings."

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document refers to physical device testing rather than machine learning algorithm training.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of Missing Information:

The provided document is a 510(k) summary for a neurovascular embolization device. It details the device's description, indications for use, comparison to a predicate device, and bench testing results. It does not contain information about clinical trials, AI performance, or studies involving human readers or expert-established ground truth in a clinical context. The "acceptance criteria" and "performance" discussed are limited to manufacturing and functional bench tests.

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Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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.

Treatment of cerebral aneurysms can be performed either by surgical clipping or endovascular techniques (e.g., embolization coils). Endovascular methods to embolize intracranial aneurysms with implantable platinum embolization coils were developed in the 1970s. Embolization coils including the MicroVention MCS and HES products are now widely used to treat all aneurysms.

The MCS consists of an implantable coil made of bare platinum alloy (Platinum/Tungsten), and the HES consists of an implantable coil made of the same platinum alloy with a hydrogel inner core. The coil is attached to a delivery pusher via a polyolefin elastomer material. 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. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment. The V-Grip is packaged and sold separately.

The modified MCS and HES devices are substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

The provided Special 510(k) K132952 describes the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The submission primarily focuses on the substantial equivalence of these devices to previously cleared predicate devices, with a minor modification related to the V-Trak Advanced delivery pusher. As such, the study summarized is a design verification and validation bench test, along with biocompatibility testing, rather than a clinical study involving human subjects or algorithm performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the individual bench tests. It refers to "design verification and validation bench tests," which typically involve a specified number of units per test to ensure statistical significance or manufacturing quality. However, the exact number of coils or components tested is not provided.

The data provenance is pre-clinical bench testing conducted in a lab environment. There is no information regarding country of origin for this testing, but it can be inferred to be from the manufacturer, MicroVention, Inc., located in Tustin, California, U.S.A. This is retrospective in the sense that it's performed on manufactured devices for regulatory submission.

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

This information is not applicable as the reported tests are physical and functional bench tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "acceptance criteria" are based on engineering specifications and established industry standards (e.g., ISO for biocompatibility).

4. Adjudication Method for the Test Set

This is not applicable as there were no subjective expert assessments that would require adjudication. The tests were objective measurements against defined acceptance criteria.

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

A MRMC comparative effectiveness study was not conducted and is not described in this submission. This type of study would typically be performed for devices involving human interpretation (e.g., imaging devices with AI assistance), which is not the case for this neurovascular embolization device.

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

A standalone performance study was not conducted and is not described. This submission is for a physical medical device (coils and delivery system), not a software algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the bench tests was based on:

• Engineering Specifications: For visual inspection and measurements ("Per product drawing").
• Performance Ratings: Based on simulated use scenarios, likely defined by internal engineering or clinical experts within the company to assess deployment, repositioning, and detachment.
• Physical Properties/Standards: For pusher resistance and detachment zone tensile strength, these refer to measurable physical properties with specific numerical ranges.
• International Standards (ISO 10993 series): For biocompatibility testing, compliance with these established standards serves as the ground truth for biological safety.

8. Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device, not a machine learning model, so there is no "training set."

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

This is not applicable as there is no training set for a machine learning model.

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The MicroPlex™ Coil System (MCS) and 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 MCS and 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 MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) consist of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heat-shrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to treatment site on the delivery pusher through standard neuro-interventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the MCS and HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that the document is a 510(k) summary, not a detailed clinical study report. Therefore, specific details like sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this type of document.

This summary focuses on showing substantial equivalence to predicate devices, rather than establishing performance against novel criteria through detailed human reader studies.

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented in such submissions is typically comparative rather than absolute, aiming to show that the new device performs at least as well as, or equivalently to, the predicate.

Here's a breakdown of the specific questions based on the provided text:

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

   • See the table above. The "acceptance criteria" for a 510(k) are implicitly tied to demonstrating "substantial equivalence" to a predicate device across various characteristics (operating principle, method of application, indications for use, design, packaging, sterilization, and performance). The reported performance is that the device is substantially equivalent and has equivalent performance in specific tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not specified in the provided document. 510(k) summaries typically do not contain this level of detail for performance testing. The "Performance Data Summary" refers to testing documented in previous 510(k)s (K012145, K021914, K020434) and states "tensile strength, coil detachment, simulated use and animal testing." Details about the number of coils tested, the number of animals used, or the origin/nature of that data are not included in this high-level summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable/Not specified. This document describes a medical device (embolization coil), not an AI or diagnostic imaging device that would typically rely on expert ground truth for performance evaluation in a clinical setting. The performance testing mentioned (tensile strength, coil detachment, simulated use, animal testing) are engineering and pre-clinical tests, not human-read clinical studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable/Not specified. As mentioned above, this type of adjudication is relevant for studies involving human interpretation (e.g., radiology readers) where a consensus ground truth needs to be established. The tests described are objective engineering and animal tests.

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, this was not done. This is a physical medical device (embolization coil), not an AI algorithm or diagnostic aid that would involve 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, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • For the "performance data" mentioned (tensile strength, coil detachment, simulated use, animal testing), the "ground truth" would be established by objective physical measurements (e.g., force required for detachment, dimensions, material integrity post-simulation) and observation of physiological effects/outcomes in animal models, rather than expert consensus on clinical images or pathology.

8. The sample size for the training set

   • Not applicable/Not specified. This pertains to machine learning algorithms, which this device is not. The "performance data" refers to validation testing, not training of an algorithm.

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

   • Not applicable/Not specified. This pertains to machine learning algorithms.

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