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The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.

This document describes the acceptance criteria and study that proves the Micrus Ascent Occlusion Balloon Catheter meets these criteria, supporting its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• In-vitro tests: The exact sample size for each in-vitro test is not specified in the summary, but multiple tests were conducted across various performance aspects.
• In-vivo study: The test set for the in-vivo study consisted of 7 devices in a porcine model.
• Data Provenance: The data provenance is from in-vitro laboratory testing and an in-vivo animal study (porcine model). This is prospective data generated specifically for the 510(k) submission. No country of origin is explicitly stated, but it can be inferred the testing was conducted by or for Micrus Endovascular Corporation, based in San Jose, CA, USA.

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

For the in-vivo study, the summary states that "the trackability of the device met physicians' acceptance" and "the device deployed effectively and as expected." This implies subjective assessment by medical professionals.

• Number of experts: Not explicitly stated, but the phrasing "physicians' acceptance" suggests more than one, or at least a general consensus attributed to medical professionals involved in the study.
• Qualifications of those experts: Not explicitly stated, but it can be inferred they were veterinarians or medical researchers with expertise in animal models and catheter deployment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "physicians' acceptance" in the in-vivo study seems to refer to a qualitative observation and concurrence, rather than a structured adjudication process for ground truth establishment.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This was a substantial equivalence submission for a modified device, focusing on demonstrating performance against established benchmarks and the predicate device's performance, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" is not applicable. The studies assessed the physical device's performance characteristics.

7. The Type of Ground Truth Used

• In-vitro tests: The ground truth for in-vitro tests was based on engineering specifications, design parameters, and established industry standards for catheter performance (e.g., balloon burst pressure, cycling durability, coating integrity).
• In-vivo study: The ground truth for the in-vivo study was based on direct observation, successful deployment, stability, and "physicians' acceptance" within the porcine model, indicating successful functionality in a biological system.

8. The Sample Size for the Training Set

This device did not involve machine learning or AI algorithms requiring a training set. The term "training set" is not applicable in this context.

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

As there was no training set (see point 8), this question is not applicable.

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The Micrus Ascent and Summit Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent and Summit Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

The Micrus Ascent and Summit Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.

The provided text is a 510(k) Premarket Notification for medical devices (Micrus Occlusion Balloon Catheters). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data to prove the device meets specific acceptance criteria related to efficacy or performance in a clinical setting.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this 510(k) summary.

Here's a breakdown of what can be inferred and what is explicitly unobtainable from the provided text:

1. A table of acceptance criteria and the reported device performance

• UNOBTAINABLE from this document. This 510(k) focuses on demonstrating "substantial equivalence" based on design, specifications, materials, and intended use, not on specific performance metrics or clinical acceptance criteria. There are no performance criteria or corresponding results reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• UNOBTAINABLE from this document. There is no mention of a "test set" or clinical study data in the traditional sense. The submission likely relies on non-clinical (bench) testing and comparisons to the predicate device to demonstrate equivalence.

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)

• UNOBTAINABLE from this document. As no specific clinical test set is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• UNOBTAINABLE from this document. No clinical test set means no adjudication method.

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

• UNOBTAINABLE from this document. This document describes a medical device (balloon catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.

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

• UNOBTAINABLE from this document. This is not an algorithm or AI device.

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

• UNOBTAINABLE from this document. No clinical ground truth is established or discussed. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• UNOBTAINABLE from this document. This is not an AI device, so there's no concept of a "training set."

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

• UNOBTAINABLE from this document. Not applicable.

Summary of Device and 510(k) Approach (based on the provided text):

The Micrus Ascent and Summit Occlusion Balloon Catheters are being submitted for 510(k) clearance by claiming substantial equivalence to an existing predicate device: K080861, Micrus Ascent Occlusion Balloon Catheter.

Key points from the document regarding the "study" (which is primarily a comparison for substantial equivalence):

• Rationale for Equivalence: The submission asserts that the new devices are substantially equivalent to the predicate in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials. The modification to the device (new sizes or slight variations) has not altered the fundamental technology of the predicate devices.
• Intended Use: The devices are intended for temporary occlusion in peripheral and neuro vasculature, to stop/control blood flow, and to assist in the delivery of diagnostic/therapeutic agents.
• Device Description: Coaxial dual lumen balloon catheters with an inner guidewire lumen and an outer inflation/deflation lumen. Designed for use over 0.014" or smaller guidewires, with a vent hole and two radiopaque markers.
• Predicate Device: Micrus Ascent Occlusion Balloon Catheter (4x7mm) cleared under K080861.

In essence, the "study" here is the compilation of documentation and analysis demonstrating that the new devices are so similar to an already cleared device that they do not raise new questions of safety or effectiveness, and therefore do not require extensive clinical trials or performance studies as would be seen for novel devices.

Ask a specific question about this device

The Micrus Ascent Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

The Micrus® Ascent™ Occlusion Balloon Catheter is a coaxial dual lumen balloon catheter comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.

The provided text is a 510(k) Premarket Notification for the Micrus Ascent Occlusion Balloon Catheter. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing new clinical study data with specific acceptance criteria as would be found in a PMA (Premarket Approval) application for novel devices often involving AI/ML.

Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, details of a study proving such criteria, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies with AI assistance.

The document states that the Micrus Ascent Occlusion Balloon Catheter is considered substantially equivalent to predicate devices based on:

• Intended use
• Design
• Specifications
• Materials
• Methods and materials in construction, packaging, and sterilization

The "study" in this context refers to the comparison made to predicate devices to establish substantial equivalence, not a performance study against specific acceptance criteria.

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