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The 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 cach consist of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single usc, sterile).

This 510(k) premarket notification for the Micrus Microcoil Delivery System does not contain a study that establishes performance against acceptance criteria in the manner typically seen for AI/ML devices or novel technologies with specific performance metrics. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The provided document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, implying that the device performs similarly to devices already on the market.

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

Not applicable. There is no mention of a "test set" or specific study data, as the submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment is not relevant in a substantial equivalence filing for this type of medical device where performance is based on similarity to existing products, rather than novel diagnostic or interventional outcomes requiring expert-driven validation.

4. Adjudication Method

Not applicable. There is no mention of a study involving adjudication.

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

No. An MRMC study is not mentioned. This type of study is typically used for diagnostic devices involving human interpretation of data, often comparing AI-assisted performance to unassisted performance. This device is an interventional tool, not a diagnostic one.

6. Standalone Performance Study

No. A standalone performance study for the algorithm (without human-in-the-loop) is not applicable or mentioned, as the device itself is a physical medical instrument, not software.

7. Type of Ground Truth Used

Not applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI/ML algorithms is not relevant here. The "truth" in this context is that the device functions as intended and is safe and effective similarly to its predicates.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device that learns from data.

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

Not applicable.

Summary of the Document's Approach:

The core of this 510(k) submission for the Micrus Microcoil Delivery System is the argument of substantial equivalence to predicate devices. This means the manufacturer is asserting that:

• Intended Use: The device shares the same intended use as legally marketed predicate devices (endovascular embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral arterial/venous embolizations).
• Design and Specifications: The design, specifications, and materials are comparable to the predicate devices.
• Safety and Effectiveness: Because of the similarities in intended use, technology, and materials, the device is considered as safe and effective as the predicate devices.

The clearance letter from the FDA confirms this determination: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "study that proves the device meets the acceptance criteria" in this case is the comparison to predicate devices and the FDA's agreement that this comparison demonstrates substantial equivalence, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.

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