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Arterial and venous embolization in the peripheral vasculature

This embolization coil system is supplied sterile and is intended for one time use. The device is comprised of an introducer system with a premounted detachable embolization coil. The embolization coil is deployed when the interlocking threads between the coil and the delivery wire are "unscrewed" by turning the delivery wire counterclockwise approximately 25 times.

The introducer system consists of a delivery wire and a delivery wire inserter. The delivery wire inserter consists of a plastic delivery wire holder with the delivery wire and a cannula inserter containing the coil. A Detach Locking Device is also needed to use the set. This part is sold separately because several coils can be delivered through one Detach Locking Device. These components are further described below.

• Coil: The coil is constructed of platinum and is available in the following shapes: curled, straight, Tornado™, J-Coil Shape and Multiple J-Coil Shape. The coil is also available in three degrees of softness: Detach 18® standard, Detach 18® soft, and Detach 110.
• Delivery Wire: The delivery wire is comprised of four components: a handle, the delivery wire, a marker band and a detach tip. These are constructed of platinum and PTFE coated stainless steel. The delivery wires for Detach 11® and Detach 18® are available in a length of 200 cm. The diameter of the Detach 11@ delivery wire is 0.011 inches. The diameter of the Detach 18® delivery wire is 0.018 inches.
• Delivery Wire Inserter: The delivery wire inserter is also comprised of four components. These include a stainless steel tip, a polycarbonate tip fitting, polyethylene tubing and a nylon fitting.
• Detach Locking Device: The Detach Locking Device is basically a pin vise which ensures that the delivery wire does not move forward during coil detachment. This device does not contact the skin or the blood.

The Embolization Coil System (Detach 11® and Detach 18®) was evaluated for safety and effectiveness through a series of tests. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria with numerical targets. However, the tests performed serve to assure reliable design and performance, and successful completion of these tests implies that the device meets the implied acceptance criteria for its intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (Tensile tests, Performance Test). It simply states that Detach 11®/18® "was subjected to the following tests."

• Test Set Sample Size: Not specified.
• Data Provenance: The tests were conducted internally by COOK INCORPORATED ("COOK INCORPORATED was subjected to the following tests"). The country of origin of the data is therefore likely the USA, where Cook Incorporated is based. The nature of the tests (tensile tests, phantom performance tests) indicates they are prospective experimental tests conducted on the device prototypes or production samples.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

It is common for such internal engineering tests to be evaluated by qualified engineers and technical personnel within the company, but specific details are not provided in this regulatory submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

For the types of mechanical and performance tests described, "adjudication" in the sense of a consensus among multiple human reviewers for subjective outcomes is not typically applicable. The results are usually quantitative (e.g., force measurements for tensile tests) or observable functional outcomes (e.g., successful deployment in a phantom). The interpretation of these results against predefined engineering specifications would be handled by the testing personnel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done.

This submission is for a medical device (embolization coil), not an AI or imaging diagnostic tool. MRMC studies are primarily relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret medical images.

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

• Standalone Performance Study: No, a standalone performance study was not done, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Tensile Tests: The "ground truth" would be established by predefined engineering specifications for strength and durability. The device's performance (e.g., ultimate tensile strength, elongation at break) would be measured and compared against these specifications.
• Performance Test in a Microferret™ Catheter Mounted in a Phantom: The "ground truth" would be the successful, unhindered deployment and detachment of the coil within the simulated anatomy. This is a functional assessment against expected operational parameters.

In essence, the ground truth is based on engineering specifications and functional performance criteria for the device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable.

This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. Design and development are based on engineering principles and iterative testing, not by training a model on data.

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

• Ground Truth for Training Set: Not applicable.

As mentioned above, there is no training set for this type of device. The design specifications and performance requirements that guide the device's development are established through engineering analysis, clinical needs assessment, and regulatory standards.

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