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The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that -- because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

The Nexus™ Detachable Coil are platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus™ Detachable Coils are designed for use with the NXT Detachment System, specifically designed for coil detachment. The NXT Detachment System is sold separately.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Detachable Coil System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document only mentions "Bench Testing" and states that a variety of tests were conducted. It does not specify the sample size used for individual tests, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). These appear to be laboratory-based engineering tests, not clinical studies involving human or animal subjects.

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

This information is not provided. Since the testing described is primarily bench testing for mechanical and material properties, it's unlikely that "experts" in the sense of medical professionals were establishing ground truth for these specific tests. Instead, the "ground truth" would be established by engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench testing, an adjudication method typically used in clinical studies (like 2+1) is not applicable. The results would likely be determined by meeting predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing and comparison to predicate devices, not on comparing human reader performance 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 assessment was not done. The Nexus Detachable Coil System is a physical medical device, not an AI or software algorithm.

7. The Type of Ground Truth Used

The ground truth for the "acceptance criteria" presented appears to be based on established engineering specifications, material standards, and performance benchmarks derived from the predicate devices. The document states "Met established criteria" for each test, implying that there were pre-defined quantitative or qualitative criteria for success.

8. The Sample Size for the Training Set

This concept is not applicable to this submission. The Nexus Detachable Coil System is a physical device, not an AI model that requires a "training set."

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

This concept is not applicable to this submission, as there is no "training set" for this physical medical device.

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