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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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The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit are intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS and HES are also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

The MicroVention 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 coil is delivered on the Delivery Pusher through standard neurointerventional microcatheters. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the coil into the microcatheter. The HydroLink Syringe Kit is packaged separately and includes a 1.0-cc syringe for system de-airing and a 0.25-cc and/or 0.5-cc syringe for coil detachment. An introducer needle is also included for use with the 0.25-cc or 0.5-cc syringe to fill the hub of the Delivery Pusher with contrast agent and eliminate any air.

The MicroPlex Coil System (MCS) is marketed in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that are used to establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide additional filling once the initial framework has been established by one or more complex coils. The MCS-CC-2D, MCS-CC-1D, MCS-HC-R and MCS-HC-S platinum coils were determined to be substantially equivalent on October 29, 2001 (reference K012145). The MCS-HC-SX platinum coils were determined to be substantially equivalent on July 9, 2002 (reference K021914). The complex and helical coils are provided in a number of diameters and lengths to meet the needs of the physician.

The MCS-HCP are platinum helical coils with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS platinum complex coils. The MCS-HCP coils were determined to be substantially equivalent on July 29, 2002 (reference K020434) and were originally included as part of the MicroPlex Coil System (MCS). In order to differentiate the platinum/polymer coils from the platinum coils, the system trade name has been changed to HydroCoil Embolic System (HES) and the coils are denoted as HES-HC-R.

This document is a 510(k) premarket notification for a medical device, the MicroPlex™ Coil System (MCS) and HydroCoil™ Embolic System (HES) with the HydroLink™ Syringe Kit. This type of submission is a declaration of substantial equivalence to a predicate device, and thus typically does not include extensive clinical studies or acceptance criteria tables as would be found in a PMA (Premarket Approval) application.

Based on the provided text, here's an analysis of the performance data:

The document states:
"Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit has equivalent performance to the predicate devices."

This indicates that the device's performance was compared to existing, legally marketed predicate devices rather than against specific, pre-defined acceptance criteria based on clinical outcomes. The study aims to show equivalence of performance, not necessarily superiority or meeting standalone performance thresholds as would be established in a clinical trial designed for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria (e.g., "tensile strength must be >X N") and detailed reported device performance values are not explicitly stated. The document only provides a high-level summary that "performance testing... demonstrated that the device has equivalent performance to the predicate devices."

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

The document mentions "Performance testing" but does not specify the sample size used for these tests. It also does not indicate the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) and the types of tests described (tensile strength, coil detachment, simulated use), these are typically benchtop or in vitro tests, not human clinical studies. Therefore, concepts like "country of origin" or "retrospective/prospective" data are not applicable in the context of this specific performance data summary.

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

This information is not applicable as the performance testing described (tensile strength, coil detachment, simulated use) pertains to the physical and functional characteristics of the device, not to diagnostic image interpretation or clinical outcomes that would require expert-established ground truth. These tests would involve engineering and materials science analyses.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as in point 3. Adjudication methods (like 2+1, 3+1) are relevant for clinical endpoints or expert consensus in diagnostic studies, not for benchtop performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit has equivalent performance to the predicate devices." This is a technical equivalence claim, not a clinical effectiveness study involving human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is an embolization coil system, a physical medical device for treatment, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is irrelevant.

7. The Type of Ground Truth Used:

For the performance testing mentioned (tensile strength, coil detachment, simulated use), the "ground truth" would be established by objective physical measurements and engineering standards, not clinical endpoints like expert consensus, pathology, or outcomes data. For example, tensile strength would be measured against ASTM standards, and coil detachment against defined functional specifications.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable for the same reason as in point 8.

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