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The Azur Peripheral HydroCoil Endovascular Embolization Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The Azur Peripheral HydroCoil Endovascular Embolization System- Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the detachment controller. The detachment controller is activated by the user and this detaches the coil. The Azur coils are designed for use with the Azur Detachment Controller, specifically designed for coil detachment.

Here's an analysis of the provided text regarding the Azur Peripheral HydroCoil Endovascular Embolization System - Detachable 35, specifically focusing on acceptance criteria and study details.

Based on the provided 510(k) summary, this submission is for a medical device (vascular embolization coil), not a software or AI-based diagnostic tool. Therefore, many of the requested categories, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and submission.

The "study" described is a bench testing verification, which is typical for physical medical devices to demonstrate safety and performance against established criteria, typically in a laboratory setting. There is no mention of clinical trials, patient data, or expert consensus being used for this specific 510(k) submission.

Here's the breakdown of the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text for each specific bench test. The phrase "Met established criteria" implies that a sufficient number of tests were performed according to a pre-defined protocol.
• Data Provenance: The tests are "Bench Testing," implying a laboratory or engineering environment. There is no indication of country of origin for data or if it's retrospective/prospective, as it's not based on patient data.

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

• Not Applicable. Ground truth, in the context of expert consensus or pathology, is not relevant for the bench testing of a physical medical device. The "ground truth" here is the engineering specifications and performance standards established for the device.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers/experts, which is not relevant for bench testing of a device's physical and functional properties.

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

• Not Applicable. This device is a physical embolization coil, not an AI software. No MRMC study was performed or is relevant for this submission.

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

• Not Applicable. This device is a physical embolization coil, not an algorithm. No standalone performance evaluation for an algorithm was performed.

7. The type of ground truth used

• Engineering Specifications and Performance Standards: For bench testing, the "ground truth" is defined by pre-established engineering specifications, performance requirements, and established industry standards for vascular embolization coils. The device's performance is measured against these objective, quantifiable criteria.

8. The sample size for the training set

• Not Applicable. This pertains to machine learning models. This submission describes a physical device, not an AI system.

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

• Not Applicable. This pertains to machine learning models.

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The Azur Peripheral HydroCoil Endovascular Embolization Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The Azur™ Peripheral HydroCoil® Endovascular Embolization System- Pushable 18 coils consist of an implantable coil packaged in an introducer along with a stylet. The stainless steel stylet is used to deploy the coil from the introducer into the delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. The Azur™ coil is platinum-based with a hydrogel polymer layer.

The provided text describes a medical device, the Azur™ Peripheral HydroCoil® Endovascular Embolization System - Pushable 18, and its regulatory clearance process, specifically related to substantial equivalence to predicate devices. It does not contain information about a study that assesses the device's performance against specific quantitative acceptance criteria or its effectiveness in a clinical setting.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be inferred and what is not available based on 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)
This information is not provided in the document. The "Verification and Test Summary Table" lists various bench tests, but does not specify sample sizes or data provenance.

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)
This information is not provided as there is no mention of a clinical test set or human expert involvement in establishing ground truth. The tests listed are bench tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a human-reviewed test set or 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
This information is not provided. This document describes a medical device for embolization, not an AI-assisted diagnostic tool or an imaging device directly involving human readers for interpretation. Therefore, an MRMC study as described is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This device is not an algorithm but a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the listed bench tests would be the established engineering specifications or performance standards for each test. For example, for "Visual Inspection," the ground truth would be that the device has no visible defects according to a defined spec. For "Dimensional Measurement," the ground truth would be that the dimensions fall within a specified range. These are not clinical "ground truths" like pathology or expert consensus.

8. The sample size for the training set
This information is not provided. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
This information is not provided as there is no AI/ML training set.

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