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

The provided text describes a medical device, the Nexus Morpheus 3D CSR, and its premarket notification (510(k)) submission to the FDA. The submission focuses on establishing substantial equivalence to a predicate device, the Nexus Tetris 3D CSR, rather than proving the device meets acceptance criteria through a study demonstrating performance metrics in a clinical setting against a defined ground truth.

Therefore, many of the requested details related to a performance study (like sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as it describes a different type of regulatory submission. The verification and test summary focuses on bench testing to ensure the new device functions similarly to the predicate.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are the established engineering and functional benchmarks for the device, and "reported device performance" indicates whether these benchmarks were met.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for these bench tests. The data provenance is internal testing performed by Micro Therapeutics, Inc. (DBA ev3 Neurovascular) on the device components. This is not clinical data, but rather engineering and material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for clinical performance studies (e.g., expert consensus on medical images or pathology results) is not relevant for the bench testing described. The "ground truth" here would be engineering specifications and standards.

4. Adjudication method for the test set

Not applicable. This was bench testing against predefined engineering criteria, not a subjective assessment requiring adjudication.

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

No. This is a medical device (neurovascular embolization coil), not an AI diagnostic or assistance system. Therefore, an MRMC study related to AI assistance is not applicable.

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

No. This is a physical medical device. "Standalone" performance in this context refers to the device's functional integrity during bench testing, not an algorithm's performance.

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

The "ground truth" for the bench tests would have been the internal engineering specifications and standards that the device's performance was measured against. This is not clinical ground truth.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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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 Helix Super Soft CSR arc platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus Helix Super Soft CSR 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 Helix Super Soft CSR device:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a Special 510(k) submission for the Nexus Helix Super Soft CSR device. This type of submission relies on the concept of substantial equivalence to a previously cleared predicate device (K050543, Nexus Detachable Coil System). Therefore, the "study" is primarily a bench testing and comparative analysis rather than a full-scale clinical trial.

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

• Sample Size for Test Set: The document does not specify the sample size used for each bench test. It merely states that the tests "Met established criteria."
• Data Provenance: The data provenance is from Micro Therapeutics, Inc., the manufacturer. It is retrospective in the sense that the testing was conducted by the manufacturer for the purpose of the 510(k) submission, likely in a controlled laboratory setting. No country of origin for the data is explicitly mentioned beyond the company's address in Irvine, California, USA.

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

• Experts and Qualifications: This information is not provided in the document. For bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert consensus in the clinical sense. The "established criteria" would have been determined by the manufacturer based on these engineering and regulatory requirements.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not applicable/provided. Bench testing results are typically objectively measured against pre-defined engineering criteria, not adjudicated by a panel in the way clinical study outcomes might be.

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: No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (neurovascular embolization coils) through a 510(k) pathway, which primarily relies on bench testing and comparison to an existing predicate device. It is not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

• Standalone Performance: Not applicable. This device is a physical embolization coil, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Ground Truth Type: The "ground truth" for the bench tests is the pre-established engineering specifications, performance standards, and safety requirements for neurovascular embolization devices, as well as the performance characteristics of the predicate device. These are derived from a combination of scientific principles, regulatory guidelines, and industry best practices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a "training set." The development of the device would involve engineering design and iterative testing, but not in the context of a "training set" for an algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable. As explained above, there is no "training set" in the context of this device and submission type.

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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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