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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

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Raptor Aspiration Catheter:
The Raptor Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Balt Aspiration Tubing Set:
The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered in various sizes that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The distal tip of the catheter shaft includes a markerband and the proximal end of the catheter has a luer fitting to allow for the attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The Raptor Aspiration Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Raptor Aspiration Catheters are compatible with 0.014" – 0.018" guidewires.

A peelable split Introducer Sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Raptor Aspiration Catheter into an appropriate vascular sheath. The catheter and Introducer Sheath are provided sterile, non-pyrogenic, and intended for single use only.

The Balt Aspiration Tubing Set consists of one 100" HPF proximal tubing with a suction connector on one end and male rotator on the other, one 1-way Large Bore Stopcock, and one 10" HPF distal tubing with a female luer connector on one end and a male rotator on the other.

The Balt Aspiration Tubing Set facilitates the supply of vacuum from a compatible aspiration pump to the distal tip of the Raptor Aspiration Catheter. Balt Aspiration Tubing Set is provided sterile, non-pyrogenic and it is intended for single use only.

The provided FDA 510(k) clearance letter pertains to the Raptor Aspiration Catheter and Balt Aspiration Tubing Set, medical devices used for revascularization in acute ischemic stroke patients. The document describes various performance tests conducted to demonstrate substantial equivalence to predicate devices.

However, it's crucial to note that this document does not describe the acceptance criteria and study for a software/AI device. The tests listed are for the physical catheter and tubing set. There is no mention of an algorithm, AI, or any software component that would require the specific information requested in the prompt (e.g., test set, ground truth, expert adjudication, MRMC study, standalone performance).

Therefore, I cannot provide information for points 1 through 9 of your request, as they are not applicable to the content of this FDA clearance letter. The device described is a physical medical instrument, not an AI/software-based diagnostic or assistive tool.

Key takeaway: The provided text is for a physical medical device (catheter and tubing) and does not involve AI or software-based performance. Therefore, the specific criteria requested for AI/software devices (like sample size, ground truth, expert adjudication, MRMC studies) are not present in this document.

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The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.

The Prestige Coil System is intended for use in the peripheral vasculature to endovascularly obstruct or occlude blood flow in vascular abnormalities of the peripheral vessels.

The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be permanently placed in the peripheral vessels to create blood stasis, reducing flow into the anomaly, and thrombosing the target site.

The provided FDA 510(k) Clearance Letter for the Prestige Coil System (Prestige Packing Coil Line Extension) does not describe a study involving an AI/Machine Learning device, human readers, or image interpretation. Instead, it describes a vascular embolization device and its mechanical and physical performance testing.

Therefore, many of the requested points in your prompt are not applicable to this document, as they relate to studies of AI performance or human reader studies in diagnostic imaging, which is not the subject of this 510(k) clearance.

However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the performance testing conducted.

Here's the breakdown based on the provided document:

Device: Prestige Coil System (Prestige Packing Coil Line Extension)

Type: Vascular Embolization Device (mechanical medical device)
Purpose: Arterial and venous embolizations in the peripheral vasculature.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document repeatedly mentions "test samples" but does not specify the exact number of samples used for each test (Visual Inspection, Dimensional Inspection, Resistance Check, and Simulated Use).
• Data Provenance: Not applicable in the context of clinical data. This refers to bench testing involving physical device samples. No specific country of origin or retrospective/prospective data collection is mentioned as this relates to device manufacturing and testing, not 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 this context refers to the defined engineering specifications and performance characteristics of the device. These are established through design controls, manufacturing standards, and engineering principles, not through expert consensus on medical image interpretation. The "experts" would be engineers and quality control personnel involved in the device's design and testing.

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

• Not Applicable. This is a concept related to consensus building among human readers (e.g., radiologists) for establishing ground truth in image-based studies. For physical device bench testing, the "adjudication" is based on objective measurements against pre-defined engineering specifications and Pass/Fail criteria. No multi-reader adjudication method applies here.

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 document describes a vascular embolization device, not an AI/Machine Learning diagnostic device. Therefore, no MRMC study or AI assistance was involved.

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

• Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the device's inherent functional capabilities as demonstrated in the bench tests, which are independent of a human operator's actions beyond following the instructions for use during the test.

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

• The "ground truth" for this device's performance testing is based on pre-established engineering specifications, design requirements, and manufacturing tolerances for the physical device. The device passes if its measured physical and functional characteristics meet these objective, pre-defined criteria. There is no biological "ground truth" (like pathology or outcomes data) in this specific submission, as it focuses on demonstrating the substantial equivalence of a modified mechanical device through bench testing.

8. The sample size for the training set

• Not Applicable. This applies to AI/Machine Learning models, not physical medical devices undergoing bench testing. The device itself is not "trained."

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

• Not Applicable. As above, this applies to AI/Machine Learning models.

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The Next Generation Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Next Generation Access Platform consists of the Next Generation Access Sheath, Dilator, Introducer Sheath, Rotating Hemostasis Valve (RHV), and Hemostasis Valve Adapter (HVA). The Next Generation Access Sheath is a single lumen, braid-reinforced, variable stiffness sheath with a radiopaque zone on the distal end and a luer hub on the proximal end. The Next Generation Access Sheath is compatible with introducer sheaths appropriately sized for the outer diameter of the Next Generation Access Sheath. The Next Generation Access Platform is provided sterile, non-pyrogenic, and is intended for single use only. The Dilator facilitates the percutaneous entry of the Next Generation Access Sheath by forming an atraumatic transition of the Next Generation Access Sheath through the skin and subcutaneous tissue to the vessel. The distal 40 cm portion of the Next Generation Access Sheath is covered with a hydrophilic coating to aid in reducing friction.

The provided text describes the regulatory clearance for the "Next Generation Access Platform" and includes performance data from bench tests, but it does not include information about AI/ML algorithm performance, ground truth, or study designs typically associated with AI/ML evaluations. Therefore, I cannot generate a response that directly addresses acceptance criteria and studies for an AI device.

It explicitly states:
"No animal study was conducted because bench performance testing was deemed sufficient for verification and validation and to support substantial equivalence."
"No clinical study was conducted because bench performance testing was deemed sufficient for verification and validation and to support substantial equivalence."

The available information pertains to a conventional medical device (a catheter platform) and its physical and biological performance characteristics, not an AI/ML device.

However, if you would like me to summarize the performance data for this conventional medical device based on the provided text, I can do that. Please clarify if that is what you would like.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text describes a 510(k) premarket notification for a medical device called the Optima Coil System (OptiBlock Line Extension). This submission focuses on demonstrating substantial equivalence to a predicate device (Optima Coil System, K223386) for which it is a modification or line extension.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance:

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

The document explicitly states "The following non-clinical bench testing was performed to evaluate the device changes and to demonstrate substantial equivalence...". It mentions "test samples" but does not specify the sample size for either of the tests performed. The data provenance is from bench testing for a medical device line extension, not involving human subjects or clinical data in this submission. Therefore, country of origin is not applicable in the context of clinical data.

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

This information is not provided in the document. Given that the studies are non-clinical bench tests, the "ground truth" would be established by engineering specifications and objective measurements rather than expert consensus on clinical cases.

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

This information is not provided and is generally not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases.

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 applicable as the described device is a neurovascular embolization coil system, not an AI software or a device that assists human readers in interpreting medical images. There is no mention of AI in the document.

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

This information is not applicable for the same reasons as point 5. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For the "Visual Inspection, Dimensional Inspection, and Resistance Check," the ground truth would be engineering specifications and manufacturing tolerances. For "Simulated Use," the ground truth would be pre-defined performance criteria within a clinically relevant model, also based on engineering and functional specifications for the device's intended operation. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these non-clinical tests.

8. The sample size for the training set:

This information is not provided and is not applicable given that this is not an AI/machine learning device. The concepts of "training set" and "ground truth for the training set" are relevant to machine learning model development, not for a physical medical device.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Next Generation Access Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liguids through the system. The Next Generation Access Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Next Generation Access Catheter is visible under fluoroscopy. The Next Generation Access Catheter dimensions are included on the individual device label. The Next Generation Access Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Next Generation Access Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.

The provided text describes the 510(k) premarket notification for the "Next Generation Access Catheter" (K234074). This documentation focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a study involving human readers with or without AI assistance, or any specific AI component that would require a ground truth established by experts. Therefore, many of the requested sections related to AI performance, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable here.

Here's a summary of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" for each test but rather states whether the device "Passed" or "Met requirements." The "Test Method Summary" implicitly defines the criteria being evaluated.

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

The document does not specify exact sample sizes for each bench test conducted. The provenance of the data is from Balt USA, LLC and describes non-clinical bench testing. There is no mention of human data, so concepts like "country of origin of the data" or "retrospective or prospective" do not apply.

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

This section is not applicable. The tests performed are engineering and biocompatibility tests on a physical medical device, not a diagnostic algorithm requiring ground truth established by medical experts.

4. Adjudication Method for the Test Set

This section is not applicable. There was no human interpretation or subjective assessment that would require an 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

This section is not applicable. This submission is for a physical medical device (catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was conducted.

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

This section is not applicable. This submission is for a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, USP) and the physical properties and performance characteristics of the device itself (e.g., directly measured dimensions, observed leakage, visual inspection for defects, comparison to a predicate device's performance).

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This section is not applicable. There is no "training set" as this is not an AI/machine learning device.

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Next Generation Aspiration Catheter:

The Next Generation Aspiration Catheter with a compatible aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment.

Balt Aspiration Tubing Set:

The Balt Aspiration Tubing Set is intended to connect the Next Generation Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The Next Generation Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite catheter that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The Next Generation Aspiration Catheter is comprised of a hollow cylindrical tube which incorporates a standard luer fitting to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The wall of the tube is constructed using a combination of metal coils and medical grade polymers. The distal portion of the Next Generation Aspiration Catheter has a hydrophilic coating which provides a lubricious surface during use to aid in tracking through the vasculature. The catheter includes a radiopaque marker providing the user with visual confirmation of the distal tip location under fluoroscopy. The Next Generation Aspiration Catheter is offered in various working lengths and nominal inner diameters and outer diameters.

An introducer sheath is provided in the package to support and facilitate the insertion of the Next Generation Aspiration Catheter's distal tip into an appropriate vascular sheath.

The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.

The Balt Aspiration Tubing Set is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Next Generation Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Balt Aspiration Tubing Set is made of common medical grade polymers, is provided sterile, and is intended for single use only.

The Next Generation Aspiration Catheter and Balt Aspiration Tubing Set are intended to be used with:

• Guidewires
• Guide Sheaths
• Aspiration Pump

The provided text is a 510(k) Summary for a new medical device, the "Next Generation Aspiration Catheter" and "Balt Aspiration Tubing Set." It details the device description, indications for use, comparison to a predicate device, and various performance tests conducted.

However, the question asks about acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI software. The provided document does not describe an AI/software device or related performance studies. Instead, it outlines the regulatory submission for a physical medical device (catheter and tubing set) and its non-clinical (biocompatibility, bench, and animal) testing for substantial equivalence to a predicate device.

Therefore, I cannot extract the information requested regarding acceptance criteria and studies proving an AI device meets them from this document. The document simply doesn't contain that type of information.

To answer your question based only on the provided text, the answer is that the document does not contain information about an AI device, its acceptance criteria, or studies proving it meets those criteria.

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The NG Delivery Catheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

The NG Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the NG Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the NG Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The NG Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

This document is a 510(k) Pre-market Notification for a medical device (NG Delivery Catheter) and, as such, does not contain information about studies related to AI/ML device performance or acceptance criteria in the context of diagnostic accuracy. The data provided focuses on the physical and biological performance of the catheter itself, demonstrating substantial equivalence to predicate devices, rather than an AI component.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study data. The document confirms that:

• No clinical testing was conducted for the NG Delivery Catheter.
• No animal testing was conducted for the NG Delivery Catheter.
• The performance data provided is for bench testing of the physical device.

The tables in the document describe biocompatibility testing and performance bench testing for the NG Delivery Catheter, along with their respective results and conclusions (all samples passed acceptance criteria or were acceptable/comparable). These tests are relevant to the safety and functionality of the physical catheter, not an AI/ML component.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text is a 510(k) Summary for a medical device called the "Optima Coil System." It describes the device, its intended use, and its comparison to a predicate device. It also includes a table of performance data from bench testing. However, this document does not contain information about a study involving human readers or AI assistance, or any data related to diagnostic accuracy, sensitivity, or specificity.

The "acceptance criteria" and "device performance" described are for bench testing only, which evaluates the physical and functional characteristics of the device itself, not its performance in a clinical scenario involving human interpretation or AI.

Therefore, I cannot fulfill the request for information related to:

• A table of acceptance criteria and reported device performance in a human-AI study. The provided table only covers bench tests.
• Sample size used for the test set and data provenance for a human-AI study.
• Number of experts used to establish ground truth and their qualifications for a human-AI study.
• Adjudication method for a human-AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a human-AI study.
• Sample size for the training set for an AI study.
• How ground truth for the training set was established for an AI study.

The document's "Performance Data - Bench" section is directly relevant to the acceptance criteria of the device's physical properties and functionality, not an AI or diagnostic performance study.

Here's the information that can be extracted from the provided text regarding device acceptance criteria and performance (bench testing):

Device Acceptance Criteria and Reported Performance (Bench Testing)

Explanation of the Bench Study (based on the provided text):

The performance data presented is from non-clinical bench testing. Its purpose was to evaluate changes made to the Optima Coil System (e.g., new coil sizes and combinations of dimensions) and to demonstrate its substantial equivalence to the previously cleared predicate device (K200030).

• Sample size: Not explicitly stated for each bench test, but implied to be "test samples."
• Data provenance: Bench testing results, implying in-house lab testing, not clinical data from patients or specific countries. It is retrospective in the sense that it evaluates a final product design.
• Experts for ground truth: Not applicable for this type of bench testing. Ground truth is based on engineering specifications, physical measurements, and performance standards.
• Adjudication method: Not applicable. Results are based on physical measurements and functional checks against pre-defined engineering criteria.
• MRMC Comparative Effectiveness Study: No, this document does not describe such a study.
• Standalone Performance: Not applicable in the context of AI; this refers to the physical device's performance.
• Type of Ground Truth: Engineering specifications, physical dimensions, material properties, and functional performance in simulated environments.
• Training Set Sample Size/Ground Truth for Training Set: Not applicable, as this document describes bench testing of a physical medical device, not the development or training of an AI algorithm.

In summary, the provided document focuses solely on the substantial equivalence of a physical neurovascular embolization device based on bench testing of its modifications. It does not contain any information related to AI performance, human-in-the-loop studies, or diagnostic efficacy.

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