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The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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.

HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher 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 provided text describes a 510(k) submission for the MicroPlex Coil System (MCS) – HyperSoft® 3D, which is a neurovascular embolization device. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (K131948, K153594). The document focuses on performance data from bench testing and biocompatibility assessments rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested details, such as human reader improvement with AI assist, ground truth establishment for training data, and expert adjudication, are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "All test samples passed testing" for bench tests and specific results for biocompatibility tests (e.g., "Non-toxic", "No sensitizer response").

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

• Sample Size for Test Set: The document states "All test samples passed testing" for bench tests, implying that the samples tested for each specific bench test (visual inspection, dimensional measurement, advancement/retraction force, simulated use, spring constant) constituted the test set for those attributes. However, the exact number of samples for each test is not specified in the provided text. For biocompatibility, the tests are performed on material samples rather than a "set" of clinical cases.
• Data Provenance: The data is generated from bench testing and biocompatibility studies conducted by the manufacturer, MicroVention, Inc., located in Tustin, California, USA. This is an in-vitro and ex-vivo type of data provenance, not human clinical data. The tests are prospective in the sense that they are specifically designed and performed to evaluate the device.

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

This information is not applicable as the study did not involve human interpretation of clinical data where a "ground truth" would be established by experts. The "ground truth" for the performance tests comes from engineering specifications, material science standards, and established biological safety protocols.

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

This information is not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). The presented studies are engineering and biological safety 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

This information is not applicable. This submission is for a physical medical device (embolization coils), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or evaluation of AI's effect on human readers was performed.

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

This information is not applicable. This submission is for a physical medical device, not an algorithm.

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

The "ground truth" for these studies is based on:

• Engineering Specifications: For visual inspection, dimensional measurement, advancement/retraction force, simulated use, and spring constant, the ground truth is adherence to the device's design specifications and functional requirements.
• International Standards (ISO): For biocompatibility tests, the ground truth is defined by the passing criteria outlined in the referenced ISO standards (e.g., ISO 10993-3, -4, -5, -6, -10, -11). These standards represent established scientific consensus on acceptable biological responses.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical device, not an AI algorithm that requires a training set.

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

This information is not applicable. No training set was used.

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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 is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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 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.

Here's an analysis of the acceptance criteria and supporting study for the MicroPlex Embolic System (MCS) Line Extension, based on the provided document:

Acceptance Criteria and Device Performance

The device, the MicroPlex Coil System (MCS) Line Extension (specifically MCS HyperSoft 3D), was subject to a series of bench tests. The acceptance criteria for these tests were established by demonstrating substantial equivalence to predicate devices (K091641 and K103758). The document explicitly states that the new device "Met the same acceptance criteria as the predicate devices" for all listed tests.

Study Details for Device Performance

It's important to note that this submission is for a Special 510(k) Line Extension, which primarily focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through bench testing and technological comparison, rather than extensive clinical studies. Therefore, many of the typical clinical study parameters (like sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this type of submission.

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

• Sample Size for Test Set: Not specified in the document. The testing described is bench testing of the device itself (coils and delivery system), not a study involving patient data.
• Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer, MicroVention, Inc. (based in Tustin, California, U.S.A.). The data is prospective in the sense that the new coils were manufactured and then tested according to established protocols.

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

• Number of Experts: Not applicable. For bench testing, "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards, rather than expert consensus on medical images or clinical outcomes.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests follow predefined protocols and acceptance criteria based on quantifiable measurements.

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

• MRMC Study Done: No. This submission is for a physical medical device (coils) and its delivery system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done: No. This is not an algorithmic or software-only device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on engineering specifications, established test methods, and the performance characteristics of the legally marketed predicate devices. The new device's performance was compared to these established benchmarks to demonstrate substantial equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no AI model involved that would require a training set. The "training" for this device's development would be the historical data and performance of previous iterations and predicate devices.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no AI training set. The design and validation of the new device are informed by the known and regulated performance of the predicate devices and general neurovascular device development principles.

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The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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 MCS VFC consists of an implantable coil made of bare platinum alloy. The MCS VFC implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end 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 MicroPlex Coil System (MCS), VFC is a neurovascular embolization device. The study performed to demonstrate its compliance with acceptance criteria was a bench test summary. This involved various physical and functional tests to ensure the device's safety and effectiveness and its equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly stated as "PASS, acceptance criteria met," indicating that the device must successfully perform the specified function or meet the measurement standard.

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

• Sample Size: The document does not explicitly state the specific number of units tested for each benchmark test. It only provides a summary of results.
• Data Provenance: The tests are described as "Bench Test Summary," implying they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these are not clinical studies.

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

This information is not applicable to this type of bench testing. "Ground truth" in the context of expert consensus, pathology, or outcomes data typically refers to clinical or image-based studies. For physical device testing, the "ground truth" is established by engineering specifications and objective measurement methods.

4. Adjudication Method for the Test Set

This information is not applicable to this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in clinical trials or image reads. For bench tests, the pass/fail criteria are objective and determined by measurement against established engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The MicroPlex Coil System, VFC is a physical neurovascular embolization device.

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

No, a standalone "algorithm only" study was not done. This device is a physical medical device, not a software algorithm. Its performance is evaluated through physical and functional bench tests, not algorithmic output against human interpretation.

7. Type of Ground Truth Used

The "ground truth" for this device's performance validation is based on engineering specifications and objective physical measurements. For example, dimensions are compared to device drawings, and tensile strength is measured against a required specification.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As in point 8, there is no training set for a physical medical device.

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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 neurovascular abnormality, 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 delivery system called a Delivery Pusher. The Delivery Pusher is powered by a hand-held, battery-powered Detachment Controller designed specifically for the MCS and HES. The Detachment Controller is provided separately.

The coil is delivered to treatment site on the Delivery Pusher through standard neurointerventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the MCS and HES into the micro-catheter. During deployment, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the controller is turned on, the coil detaches.

The provided documentation describes a 510(k) premarket notification for the MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES). This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, and performance metrics in the typical sense of a de novo or PMA submission is not explicitly available in this document. The document emphasizes equivalence through design, materials, and existing performance.

Here's an analysis based on the information provided, highlighting what is and isn't available:

There are no specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) provided in this document as it is a 510(k) for substantial equivalence. The "performance data" referred to is primarily comparative testing against predicate devices to demonstrate equivalent performance, rather than a standalone study establishing new performance benchmarks.

Acceptance Criteria and Reported Device Performance

Study Information (Based on Substantial Equivalence Approach)

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

   • Not Applicable (N/A) / Not provided in this document. No "test set" in the sense of a clinical or analytical performance study is detailed. The performance data mentioned relates to comparative testing for substantial equivalence, likely bench or animal testing, not a clinical trial with a defined test set of patients or medical images.

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

   • N/A / Not provided. Ground truth establishment by experts is typically done for diagnostic or prognostic devices, often involving human interpretation of medical data. This document describes a medical device for embolization, where performance is assessed through engineering and possibly animal studies, not expert ground truth on a test set.

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

   • N/A / Not provided. As no clinical "test set" requiring expert interpretation and adjudication is described, this information is not relevant to this submission type.

4. 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, an MRMC study was not done. This device is an embolization coil system, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies are not applicable.

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

   • N/A / Not applicable. This is a physical medical device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A / Not explicitly stated for performance testing. For a mechanical device, ground truth often relates to engineering specifications, material properties, detachment mechanisms, and possibly animal studies demonstrating successful embolization. The document only vaguely mentions "performance testing."

7. The sample size for the training set:

   • N/A / Not applicable. There is no "training set" in the context of an AI/ML algorithm or a device that learns from data.

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

   • N/A / Not applicable. As there is no training set, this information is not relevant.

In summary: The provided document is a 510(k) submission for substantial equivalence. It does not detail specific acceptance criteria or a comprehensive study with the types of metrics and methodologies commonly found in submissions for AI/ML devices or novel diagnostic tools. The "performance data" mentioned refers to comparative testing that established equivalence to predicate devices in design, materials, manufacturing, and intended use.

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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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The MicroPlex Coil System (MCS) is 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 is 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) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. 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 implantable coil into the microcatheter.

The MCS-CC is a platinum complex coil that establishes the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC is a platinum helical coil that provides additional filling once the initial framework has been established by one or more complex coils. The complex and helical coils are provided in a number of diameters and lengths. The MCS-HCP is a platinum helical coil 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-CC complex coils.

The MCS-CC and MCS-HC are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters. The MCS-HCP is available in 14-compatible systems and may be delivered through 14-type micro-catheters.

The provided text is a 510(k) premarket notification for a medical device, the MicroPlex™ Coil System (MCS). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device. The document is for a physical embolization coil system.

Here's a breakdown of why the requested information cannot be extracted from the provided text, based on the nature of a 510(k) for a physical medical device:

1. Table of acceptance criteria and reported device performance: This document does not present specific acceptance criteria in a quantitative table format. It states that "Performance testing including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices." This implies that the performance was deemed acceptable if it was equivalent to the predicate, but no specific numerical targets or results are provided.

2. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to the physical device being tested (e.g., coils for tensile strength). The document does not specify sample sizes for these tests, nor the provenance of such "data" in the epidemiological sense.

3. Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth, in the context of AI or diagnostic studies, refers to the definitive determination of a condition. For a physical device like an embolization coil, ground truth would be established through engineering tests, material science evaluations, and potentially animal studies, not typically by human experts adjudicating cases of patient data as described.

4. Adjudication method: Not applicable, as there's no diagnostic task involving human expert review of cases.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, sometimes aided by AI) to assess inter-reader variability and the impact of the device on reader performance. The MCS is a therapeutic device.

6. Standalone (algorithm only) performance: Not applicable. The MCS is a physical medical device, not an algorithm.

7. Type of ground truth used: For the performance tests mentioned (tensile strength, coil detachment, simulated use, biocompatibility, animal testing), the "ground truth" would be established by the physical measurements, chemical analyses, and physiological responses observed in the animal models, rather than expert consensus, pathology, or outcomes data from human subjects in a clinical trial for a diagnostic device.

8. Sample size for the training set: Not applicable. The MCS is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) notification for a physical medical device. The types of questions asked are highly specific to AI/ML software as a medical device (SaMD) or diagnostic devices that involve human interpretation. This document does not contain information relevant to those types of questions.

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