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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 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/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 thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided document is a 510(k) Pre-Market Notification for the Optima Coil System. It focuses on demonstrating substantial equivalence to a predicate device through performance bench testing, animal testing, biocompatibility studies, sterilization validation, and shelf-life/packaging testing. It does not contain information about studies involving human readers, AI assistance, or expert-established ground truth which are typically associated with performance evaluations of diagnostic or AI-driven medical devices.

Therefore, I cannot provide information for points 1-9 as they are not applicable to the content of this document. The document describes a medical device (neurovascular embolization coil system) and its mechanical, material, and biological performance, not an AI or diagnostic tool.

The "device performance" mentioned in the document refers to how the physical device (the coil system) performs in various mechanical and biological tests, not its accuracy in diagnosing or interpreting medical conditions.

Here's an explanation of why the requested information isn't present in the document:

• Acceptance Criteria and Reported Device Performance (Table): The document lists "Test Method Summary" and "Results" for various tests (e.g., Corrosion Resistance, MRI Compatibility, Biocompatibility). The acceptance criterion for all these tests is implicitly "All test samples passed testing", which is consistently reported as the result. However, the exact numerical acceptance ranges or thresholds are not detailed for each specific test, only the pass/fail outcome.
• Sample Size (Test Set) and Data Provenance: Sample sizes are not explicitly stated for individual bench tests. For animal testing, it mentions "acute porcine model" but not the number of animals. Biocompatibility studies specify "3 Rabbits" for a 4-week implantation and "4 Rabbits" for a 13-week implantation. No data provenance in terms of country of origin is mentioned. All studies appear to be prospective lab/animal studies.
• Number of Experts and Qualifications (Ground Truth): Not applicable. This document does not describe studies that require human experts to establish ground truth, as it's not a diagnostic or AI-driven device.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The "device performance" shown is standalone performance of the physical device via bench and animal testing.
• Type of Ground Truth: For the mechanical and biological tests, the "ground truth" is defined by established scientific and engineering principles, international standards (e.g., ISO, ASTM), and the requirements for a safe and effective medical device. For example, for biocompatibility, the ground truth is that the device should not be cytotoxic, sensitizing, irritant, etc., as determined by standardized biological assays.
• Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.
• Ground Truth for Training Set: Not applicable.

In summary, the provided text details the regulatory submission for a physical medical device. The types of evaluations described are standard for such devices (mechanical, material, biological safety), and do not involve AI performance metrics or human reader studies.

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The Barricade Embolization Coil System is intended for the endovascular embolization of intracranial anewysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Embolization 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 venous embolizations in the peripheral vasculature.

The Barricade Embolization Coil System (BCS) is a series 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/tungsten, affixed to a delivery pusher with an introducer sheath 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 electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

This document describes the Barricade Embolization Coil System, a medical device, and its acceptance criteria as demonstrated by performance data. It is a 510(k) Summary, meaning the device is being compared to previously cleared predicate devices to establish substantial equivalence.

Here's the breakdown of the requested information:

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

The document doesn't provide a direct "acceptance criteria" table with specific numerical limits for each test. Instead, it states that the modified device met all specified criteria and performed as intended, demonstrating substantial equivalence to the predicate devices. The performance data section lists the types of tests conducted and concludes that the modified device "met all specified criteria and did not raise new safety or performance questions."

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

• Sample size: The document does not explicitly state the sample size for the "test units representative of finished devices."
• Data provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It describes "comparative simulated use testing," which implies laboratory or in-vitro testing rather than human clinical data.

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 in the document. The testing described (visual inspection, dimensional measurement, simulated use, tensile tests) does not typically involve expert review for "ground truth" in the way clinical studies or diagnostic AI algorithms do. It's focused on engineering and performance specifications.

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

This information is not provided and is not applicable to the type of engineering and performance testing described. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that may be ambiguous.

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

There was no MRMC comparative effectiveness study and no discussion of human readers or AI assistance. This device is a physical medical device (embolization coils), not an AI algorithm for diagnosis or interpretation.

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

This question is not applicable as the device is a physical embolization coil system, not an algorithm.

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

The concept of "ground truth" as it applies to an AI model or diagnostic test is not directly applicable here. For this physical device, the "truth" is whether it meets its engineering specifications and performs its intended function safely and effectively in simulated environments. This would be verified through:

• Engineering specifications and measurements (dimensional, tensile).
• Functional performance in controlled simulated environments (e.g., fluid dynamics models for embolization).

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for this physical device.

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The Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS 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 Barricade Embolization Coil System (BCS) is a series 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/tungsten, affixed to a delivery pusher with an introducer sheath 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 electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

This document is a 510(k) premarket notification for the Barricade Embolization Coil System. It does not describe an AI/ML powered medical device, but rather a traditional medical device (embolization coil system). Therefore, most of the requested information regarding AI/ML device performance and study design (sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the study performed based on the provided text, as it relates to the substantial equivalence determination for this particular medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study was a series of verification and validation tests comparing the modified Barricade Embolization Coil System to its predicate devices (K134482, K131475, K123338, K140104). The goal was to assure substantial equivalence and demonstrate that the device performs as intended.

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

• Sample Size for Test Set: The document states that "All testing was performed on test units representative of finished devices," but does not explicitly provide the specific number of units or data points used for each test.
• Data Provenance: The data is generated from laboratory testing ("verification and validation testing") on the device itself. This is not clinical data from patients (e.g., country of origin is not applicable in this context). The testing is prospective for the purpose of this 510(k) submission.

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

• This is not applicable as the tests performed are primarily engineering and simulated use performance tests on the physical device, not interpretative tasks requiring expert ground truth (e.g., radiology interpretation).

4. Adjudication Method for the Test Set:

• Not applicable for the types of engineering and simulated use performance tests described. The results are objective measurements against defined specifications.

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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" for these performance tests is based on pre-defined engineering specifications and performance standards. For example, a tensile strength test would have a specific range of acceptable values, or a simulated use test would have defined operational outcomes (e.g., successful deployment, detachment). The comparison is also made against the performance of predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

• Not applicable. As above, this is not an AI/ML device.

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The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade 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 Barricade Embolization Coil System (BCS) is a series 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/tungsten, affixed to a delivery pusher with an introducer sheath 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 electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

Here's an analysis of the provided text regarding the Barricade Embolization Coil System's acceptance criteria and study information:

This document is a 510(k) summary for a medical device (Barricade Embolization Coil System), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical trial with detailed acceptance criteria for a novel AI algorithm. Therefore, many of the requested points related to AI performance, ground truth, and expert adjudication are not applicable to this type of submission.

The "study" in this context refers to the non-clinical performance testing conducted to show the device functions as intended and is comparable to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated. The document mentions "test units representative of finished devices," but does not provide specific numbers for each test.
• Data provenance: Not explicitly stated. The testing was performed internally by the manufacturer, Blockade Medical. Given it's a 510(k) summary, the tests are typically conducted in a laboratory setting. No information on country of origin of data (likely USA, where Blockade Medical is located) or retrospective/prospective nature is provided, as these are non-clinical engineering tests.

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

• Not applicable. This device is a physical medical implant, not an AI algorithm requiring expert ground truth for image or data analysis. The "ground truth" here is adherence to engineering specifications and functional performance.

4. Adjudication method for the test set

• Not applicable. See point 3. Testing involved standard engineering measurements and visual inspections against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI diagnostic, prognostic, or assistive device. It is a physical embolization coil system. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or is relevant.

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

• Not applicable. See point 5.

7. The type of ground truth used

• Engineering Specifications and Functional Performance Benchmarks: The "ground truth" for this device's performance is adherence to established engineering specifications (e.g., dimensions, material properties, detachment mechanism) and functional performance observed during simulated use testing that demonstrates its intended operation and comparability to predicate devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is based on physical device testing, not data training.

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

• Not applicable. See point 8.

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The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysm and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade 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 Barricade Embolization Coil System (BCS) is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other The system consists of an embolization coil implant comprised of vascular anomalies. platinum/tungsten, affixed to a delivery pusher with an introducer sheath 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 electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided text describes a 510(k) summary for the Barricade Embolization Coil System, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of a new AI or diagnostic device is not applicable here.

This submission is for a modification to an existing neurovascular embolization device (Barricade Embolization Coil System) and aims to show that the modified device is substantially equivalent to the previously cleared predicate devices (K123338 and K131475). The modifications primarily relate to the inclusion of an optional Handheld Detachment Cable.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state numerical or specific performance acceptance criteria. Instead, the acceptance criteria are implicitly defined by "sameness" or "no adverse effect" compared to the predicate device's established performance, and meeting general standards like "adequate tensile strength" and "Sterility Assurance Level 10^-6". This is typical for 510(k) submissions demonstrating substantial equivalence for minor modifications.

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size (N) for each test (Simulated Use, Tensile Test, Packaging Validation, Sterility).

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." Given that these are bench and lab tests, the data would originate from the testing facility (most likely in the US, where Blockade Medical is located). These tests are typically conducted prospectively as part of the verification and validation process for the device modification.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" and "experts" in this context typically refer to clinical or diagnostic evaluation where human interpretation is involved (e.g., radiologists reading images). This submission pertains to the physical and functional performance of a medical device, evaluated through engineering and laboratory tests.

4. Adjudication Method for the Test Set

This is not applicable as there is no clinical test set requiring adjudication of findings (e.g., image interpretations). The tests performed are objective, quantitative measurements in a laboratory setting.

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 is not applicable. The device is a physical embolization coil system, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. The device is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., tensile strength, sterility) is based on objective engineering and laboratory measurements against established standards and internal specifications, and comparison to the predicate device's known performance. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reasons as above.

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The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade 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 Barricade Embolization Coil System (BCS) is a series 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/tungsten, affixed to a delivery pusher with an introducer sheath 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 electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided text describes a 510(k) summary for the Barricade Embolization Coil System, focusing on demonstrating substantial equivalence to a predicate device. It details the technical characteristics and the performance data that was collected.

Here's an analysis of your requested information 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)

The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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 in the text. The testing conducted was focused on engineering performance (visual inspection, dimensional measurement, simulated use, detachment zone tensile) rather than clinical evaluation requiring expert ground truth in the context of diagnostic or interpretive tasks.

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

This information is not applicable and therefore not provided in the text. The type of testing described (engineering verification and validation) does not involve adjudication by multiple human experts in the way clinical studies or image-based diagnostic device studies do.

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 MRMC comparative effectiveness study was done or mentioned. This document pertains to a medical device (embolization coil system) and its physical and functional performance, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This is not applicable. The device is a physical embolization coil system, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

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

The "ground truth" for the engineering performance tests would be the engineering specifications and design requirements for the device. For example, a "visual inspection" would verify that the device meets visual quality standards, a "dimensional measurement" would confirm it meets specified dimensions, and "simulated use" would confirm its functional performance in a simulated environment as designed. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.

8. The sample size for the training set

This is not applicable. The device is a physical medical implant, not an AI model that requires a training set.

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

This is not applicable. As mentioned in point 8, there is no training set for this device.

Ask a specific question about this device

The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade 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 Barricade Embolization Coil System (BCS) is a series 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/tungsten, affixed to a delivery pusher with an introducer sheath 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 electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided text describes the 510(k) summary for the Barricade Embolization Coil System, a neurovascular embolization device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies is not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets for device performance in the way an AI/software device would. Instead, it lists various verification and validation tests and their results, primarily focusing on proving safety and substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion of these tests and their favorable outcomes, indicating non-toxicity, appropriate mechanical properties, and similar performance to predicate devices.

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