Search Results

The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit ("DPU")

This document, K082739, is a 510(k) premarket notification for a medical device called the "Micrus Microcoil Delivery System." It aims to demonstrate substantial equivalence to previously cleared devices rather than prove the device meets specific acceptance criteria through a formal study with statistical endpoints. As such, the provided text does not contain the information required to populate most sections of your request.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence through design, material, function, and intended use comparison, along with non-clinical testing. It does not detail specific performance metrics and acceptance criteria for patient outcomes or diagnostic accuracy that would be found in a clinical study for a new device.

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

This information is not applicable/not present. No "test set" in the context of a clinical study for performance evaluation is described. The submission relies on "non-clinical testing" which typically refers to bench testing, engineering tests, and biocompatibility, not patient data for performance evaluation in the way you're asking.

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

This information is not applicable/not present. As there is no clinical test set described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

This information is not applicable/not present. No clinical test set or adjudication process is described.

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

This information is not applicable/not present. The document does not describe any MRMC study. The comparison is to predicate devices through design and function, not through a clinical performance comparison with human readers.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable/not present. This device is a physical medical device (microcoil delivery system), not an algorithm or AI-based diagnostic tool.

7. Type of Ground Truth Used:

This information is not applicable/not present in the context of a clinical performance study. For the substantial equivalence claim, the "ground truth" or basis of comparison is the safety and effectiveness of the predicate devices as established by their prior FDA clearance. The assessment is then whether the new device is "substantially equivalent" to these already cleared devices, meaning its design, materials, function, and intended use are similar enough that it raises no new questions of safety or effectiveness.

8. Sample Size for the Training Set:

This information is not applicable/not present. This is not a study involving a "training set" for an algorithm or a clinical trial with patient enrollment numbers.

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

This information is not applicable/not present.

Summary of what the document does state regarding acceptance criteria and "proof":

The document states that the Micrus Microcoil Delivery System with a new "Device Positioning Unit" has shown substantial equivalence to FDA-cleared and marketed Micrus Microcoil Systems.

The "proof" for this substantial equivalence is based on:

• Comparison of intended use, design, material, method of construction, and dimensions to predicate devices.
• The assertion that "The modification has not altered the fundamental technology of the predicate devices."
• Non-clinical testing performed by Micrus Endovascular Corporation. (The specifics of this testing, its acceptance criteria, and results are not detailed in this summary document.)

Conclusion:

This 510(k) summary is designed to demonstrate that the modified device is substantially equivalent to existing, cleared devices. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, etc.) that would be found for a novel device undergoing a performance study or a clinical trial with predefined endpoints. The "acceptance criteria" here implicitly align with the FDA's requirements for substantial equivalence for a Class II device.

Ask a specific question about this device

The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus Microcoil Delivery System consists of (1) An embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile). (2) An Connecting Cable ("CCB") (3) A Detachment Control Box ("DCB")

The provided documentation is a 510(k) summary for the Micrus Microcoil Delivery System and related FDA correspondence. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, many of the requested categories (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available from the provided text:

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

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: Not applicable/Not provided. This submission relies on "non-clinical testing" and comparison to a predicate device, not a clinical study with a test set in the context of AI/ML.
• Data Provenance: Not applicable/Not provided.

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 provided. The ground truth concept as typically applied to AI/ML devices for diagnostic accuracy is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

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

• Not applicable/Not provided.

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 Done?: No. This type of study is not relevant for this device submission which focuses on substantial equivalence of a physical medical device.
• Effect Size: Not applicable.

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

• Not applicable. This is not an AI/ML algorithm. The submission is for a physical medical device.

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

• Ground Truth Type: For this submission, the 'ground truth' is implicitly the established safety and effectiveness profile of the legally marketed predicate devices (Micrus Microcoil Delivery System, 510(k) K002056 and K031578). The new device is shown to be substantially equivalent to these.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device trained on data.

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

• Not applicable/Not provided.

Ask a specific question about this device

Ask a specific question about this device