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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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