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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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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 Vector consists of an implantable coil made of bare platinum alloy. The Vector 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroPlex Coil System - Vector:

No clinical studies are mentioned in the provided text. This 510(k) summary primarily focuses on establishing substantial equivalence through bench testing and comparison of physical properties and intended use with predicate devices. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be addressed from this document.

1. Table of Acceptance Criteria and Reported Device Performance

Implicit Acceptance Criteria: The document states that the MicroPlex Coil System - Vector "Met same criteria as predicate" for all listed bench tests. This implies that the acceptance criteria for each test were the established performance benchmarks of the predicate devices: MicroPlex Coil System - Cosmos 10 (K082461, K093919, K103758) and MicroPlex Coil System - Cosmos 18 (K090891, K093358). The specific numerical values or ranges for these criteria are not provided in this summary.

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

• Sample Size: Not specified. The document refers to "bench tests" but does not provide details on the number of samples tested for each criterion.
• Data Provenance: The study is in-vitro bench testing, not involving human data.

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

• Not Applicable. This document describes bench testing, not a study requiring expert-established ground truth on patient data.

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

• Not Applicable. This document describes bench testing, not a study requiring adjudication of expert opinions on patient data.

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

• Not Applicable. No MRMC or human-in-the-loop study was described. This is a medical device for embolization, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a medical device for embolization, not an algorithm. Bench testing evaluates the physical and functional performance of the device itself.

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

• Physical Benchmarks/Engineering Specifications: The "ground truth" for the bench tests would have been the established engineering specifications and performance characteristics of the predicate devices, which the new device aimed to match or exceed.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

In summary: The provided 510(k) summary for the MicroPlex Coil System - Vector demonstrates the device meets acceptance criteria through bench testing, specifically by showing that its physical properties and simulated use performance "met same criteria as predicate" devices. The document does not contain information about clinical trials, human data, AI performance, or expert adjudication, as it relies on substantial equivalence to previously cleared devices based on non-clinical performance data.

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Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and 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 MCS Cosmos 10 consists of an implantable coil made of bare platinum alloy. The HES HydroFrame 10 consists of implantable coil made of platinum alloy with a biologically inert and stable inner hydrogel core. Both the Cosmos 10 and the HydroFrame 10 coils are available in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the delivery pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implantable coil detaches upon activation of the Detachment Controller.

Both the Cosmos 10 and the HydroFrame 10 coil implants have a PET member within the primary coil to provide stretch resistance properties. Both feature a 3-dimensional shape that creates a frame when placed within an aneurysm.

The HydroFrame 10 also has a hydrogel core member that runs parallel with the stretch resistant member within the coil. The expansion properties of the hydrogel allow for improved filling properties of the implanted coil.

The provided text describes a 510(k) submission for MicroPlex Coil System – Cosmos 10 and HydroCoil Embolic System - HydroFrame 10, which are neurovascular embolization devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against new, specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted in the way typically expected for a clinical performance study. The submission primarily relies on bench test comparisons to establish equivalence, implying that if the new devices perform similarly to the predicate devices in these tests, they meet the same implicit acceptance criteria as the legally marketed predicates.

Here's a breakdown of the available information based on your request:

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

Since this is a 510(k) addressing a line extension, explicit "acceptance criteria" for clinical performance are not stated in the provided documents. Instead, the "performance" is demonstrated by showing equivalence to the predicate devices through bench testing. The acceptance criterion for each test is implicitly "Met same criteria as predicate."

2. Sample sized 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 does not specify exact sample sizes for each bench test. These are typically performed on a statistically significant number of units according to internal quality standards, but the specific numbers are not provided in this summary.
• Data Provenance: The data is based on bench testing performed by MicroVention, Inc. (Tustin, California, U.S.A.). It is by nature prospective as it involves testing newly manufactured devices.

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):

This information is not applicable to the provided document. The "tests" described are bench tests of physical and mechanical properties, not clinical evaluations requiring expert interpretation of images or patient outcomes. The "ground truth" for these tests would be established by objective measurements and comparisons against engineering specifications and predicate device performance.

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 interpreting ambiguous clinical data or images. Bench tests rely on objective measurement and comparison.

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. The device is a physical embolization coil, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this device.

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

This information is not applicable. The device is a physical embolization coil, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

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

For the bench tests, the "ground truth" is derived from:

• Engineering specifications and design parameters.
• Measured physical and mechanical properties that demonstrate equivalence to the predicate devices.
• Pre-established performance characteristics of the predicate devices.

8. The sample size for the training set:

This refers to a training set for an algorithm, which is not applicable in this context. The devices are physical medical devices, not algorithms requiring a training set.

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

This question is not applicable as there is no algorithm or "training set" for this physical medical device.

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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 Cosmos coils 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 a V-Trak™ delivery pusher via a polymer filament. 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 (sold separately). The implant segment detaches upon activation of the Detachment Controller.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details as requested:

Device: MicroPlex Coil System - Cosmos 18 (Neurovascular Embolization Device)

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device submission (K102365), the acceptance criteria and reported performance are based on equivalence to the predicate device (MicroPlex Coil System - Cosmos 18, K093358, K090891). The study conducted was primarily a bench test comparison rather than a clinical study with performance metrics in terms of accuracy or clinical outcomes.

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

• Sample Size: Not explicitly stated. The bench tests are typically conducted on a set number of devices to demonstrate consistency and adherence to specifications. However, the exact quantity of coils tested is not provided in this summary.
• Data Provenance: The data is presumed to be from prospective bench testing conducted by MicroVention, Inc. at their facility in Tustin, California, U.S.A. It is not patient or clinical data.

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

• This information is not applicable as the study was a bench test comparison to a predicate device, not a study requiring expert clinical ground truth on patient data. The "ground truth" here is adherence to engineering specifications.

4. Adjudication Method for the Test Set

• This information is not applicable as the study was a bench test, not a clinical study involving human assessment that would require adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for a device modification (larger coil sizes) demonstrated through bench testing and comparison to an existing predicate device, not for an AI-assisted diagnostic tool or a therapy where human reader performance improvements would be measured.

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

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

7. Type of Ground Truth Used

• The "ground truth" used for this submission is based on engineering specifications and performance characteristics of the predicate device. The new device's performance was compared to meet the same specifications as the predicate.

8. Sample Size for the Training Set

• This information is not applicable. The 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

• This information is not applicable as there is no training set for this type of device.

Summary of the Study:

The submission for the MicroPlex Coil System - Cosmos 18 (K102365) primarily relies on bench testing to demonstrate substantial equivalence to its predicate device (K093358, K090891). The new device introduces larger coil outer diameters and lengths but maintains the same design attributes, materials, and operating principles as the predicate. The "study" consisted of a series of standard engineering performance tests (e.g., visual inspection, dimensional measurement, simulated use, tensile strength, spring constant) where the subject device was shown to meet the same specifications as the predicate device. This approach is common for 510(k) submissions of modified devices where material or fundamental operating principles have not significantly changed, and clinical performance is assumed to be equivalent to the predicate.

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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 Cosmos 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 a V-Trak™ MCS delivery pusher via a polymer filament. 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 implant segment detaches upon activation of the Detachment Controller.

The MicroPlex Coil System - Cosmos (K093919) is a neurovascular embolization device. The provided document is a 510(k) summary, which indicates that the device's acceptance criteria and performance are typically evaluated through substantial equivalence to a predicate device, rather than a clinical study with detailed statistical endpoints.

Based on the provided information, here's a breakdown of the acceptance criteria and the "study" (bench testing) that demonstrates the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MicroPlex Coil System - Cosmos are defined by the predicate device's established performance and design specifications. The "reported device performance" in this context refers to the results of bench tests conducted to demonstrate that the new device meets these pre-established criteria. The document states that all listed tests "Met established criteria," implying satisfactory performance against predefined internal specifications or industry standards.

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

The document explicitly states that the submission is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" and that the "Cosmos Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal."

This indicates that the primary "study" proving the device meets acceptance criteria is bench testing to demonstrate performance similar to the predicate device. The document does not specify the sample size used for each of the listed bench tests.

Regarding data provenance:

• Country of Origin: The submitting company, MicroVention, Inc., is based in Tustin, California, U.S.A. Therefore, the bench testing was likely conducted in the USA.
• Retrospective or Prospective: Bench testing, by its nature, is a prospective evaluation where tests are designed and performed to assess the device's characteristics. It is not based on historical patient data.

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

Since this is a 510(k) for a device demonstrated through substantial equivalence and bench testing, there is no mention of experts involved in establishing ground truth for a test set in the clinical sense. Ground truth for bench testing would typically be engineering specifications, established scientific principles, or comparison to the predicate device's known performance. These are not typically established by clinical experts in the same way as, for example, a radiologist establishing ground truth for an imaging AI algorithm.

4. Adjudication Method for the Test Set

As there is no clinical test set or human expert review described for establishing ground truth, there is no adjudication method mentioned. The "acceptance criteria" are likely engineering specifications or performance metrics derived from the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned in this 510(k) summary. This type of study is common for evaluating the effectiveness of AI-assisted diagnostic tools, which is not the nature of this device (a physical neurovascular embolization coil).

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 implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria for this device is based on:

• Engineering Specifications: Pre-defined technical requirements for the device's visual, dimensional, and mechanical properties.
• Performance of the Predicate Device: The MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891) serves as the benchmark against which the new device (Cosmos) is compared for substantial equivalence. The predicate device's established safety and effectiveness dictate the expected performance of the new device.

There is no mention of pathology, outcomes data, or expert consensus in a clinical setting establishing "ground truth" for these bench tests.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven model development.

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

Not applicable. As stated above, there is no training set for this device.

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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.

The Cosmos 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 a V-Trak™ MCS delivery pusher via a polymer filament. 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 implant segment detaches upon activation of the Detachment Controller.

The provided 510(k) summary describes a neurovascular embolization device, the MicroPlex Coil System - Cosmos, and primarily focuses on demonstrating its substantial equivalence to a predicate device through bench testing. As such, the study does not involve AI or human reader 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 the data provenance

The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory-based testing of the device components. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to bench testing.

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

Not applicable. Bench testing does not involve human experts to establish ground truth in the way clinical studies or AI performance validations do. The "ground truth" for bench tests is defined by established engineering and manufacturing specifications and test methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" are used in clinical trials or evaluations where there's subjectivity and disagreement among human reviewers. Bench tests follow objective, predefined protocols and measurements.

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 device (neurovascular embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for these bench tests would be the pre-defined engineering specifications, material properties, and functional performance requirements for the device. These are objective and measurable parameters established during the device's design and development.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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