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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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The Penumbra Coil System is indicated for the embolization of:

• Intracranial aneurysms .
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous . fistulae
• Arterial and venous embolizations in the peripheral vasculature .

The Penumbra Coil System consists of the following components, which are sold separately:

• . Complex Standard Implantable Embolization Coils attached to detachment pusher
• . Complex Soft Implantable Embolization Coils attached to detachment pusher
• . J Soft Implantable Embolization Coils attached to detachment pusher
• . Curve Extra Soft Implantable Embolization Coils attached to detachment pusher
• . Detachment Handle

The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.

The Penumbra Embolization Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.

This document describes the Penumbra Coil System, which is an embolization coil system. The information provided is a 510(k) summary for premarket notification to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than the specific performance metrics of a diagnostic AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to this type of device and submission. The document primarily details biocompatibility and design verification tests, which are typical for medical implants.

However, I can extract information relevant to the acceptance criteria and study proving it, as available from the provided text.

Acceptance Criteria and Reported Device Performance

Explanation of the Study and its Findings:

The "study" presented here is a summary of non-clinical data for a 510(k) premarket notification. The primary goal is to demonstrate "Substantial Equivalence" to a legally marketed predicate device (Guglielmi Detachable Coil - GDC™). This is achieved by showing that the Penumbra Coil System has comparable indications for use, fundamental technological characteristics (materials, sterilization), and meets established safety standards through various testing.

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

   • Biocompatibility: The specific sample sizes for each test (e.g., number of animals for in-vivo tests, number of cells for in-vitro tests) are not provided in this summary. However, the tests were conducted "in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices)" and "pursuant to 21 CFR, Part 58, Good Laboratory Practices," implying standard and appropriate sample sizes were used for these types of studies. The provenance is internal testing conducted according to international standards for medical devices.
   • Design Verification (Bench-Top Testing): The document states "All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures." Specific sample sizes for each physical/mechanical test are not provided, but it notes "all sizes" for Dimensional/Visual Inspection. The provenance is internal bench-top testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert interpretation of results. The "ground truth" for biocompatibility tests is the biological response, and for design verification, it's the physical/mechanical properties measured against engineering specifications.

3. Adjudication method for the test set: Not applicable for this type of device testing. Results are typically objectively measured against pre-defined performance specifications (e.g., "non-toxic," "non-irritant," "passed successfully").

4. 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 an embolization coil, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.

6. The type of ground truth used:

   • Biocompatibility: Biological responses (e.g., cellular toxicity, systemic effects, sensitization, pyrogenicity, hemocompatibility, tissue reaction to implantation) as defined by ISO 10993 standards and measured by laboratory tests.
   • Design Verification: Established engineering specifications, physical and mechanical properties, and performance benchmarks for the device components.

7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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The HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.

The HydroSoft and HydroSoft Plus Embolization Coils Systems also are 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 embolization in the peripheral vasculature.

The HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are platinum embolization coils with an inner hydrogel core, and a V-TrakTM Delivery Pusher.

The provided document is a 510(k) premarket notification for a medical device called "HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not describe, nor does it require for a 510(k) submission, the specific information requested about acceptance criteria, a study proving device performance against such criteria, sample sizes, ground truth establishment, or clinical effectiveness studies in the format typically associated with a new device approval.

Instead, the submission focuses on comparing the new device to a predicate device (HydroCoil® Embolic System with (HES) with the HES-HC-HS (10) Coils (K070656)) to establish substantial equivalence based on material, design, and intended use. The performance attributes mentioned would typically refer to bench testing or animal studies demonstrating similar functional characteristics, rather than human clinical trials with performance metrics for an AI/algorithm-driven device.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's an attempt to address the request based on the available information, noting where information is not present:

Acceptance Criteria and Study for K080666: HydroSoft® and HydroSoft Plus Embolization Coil Systems

This 510(k) submission establishes substantial equivalence for the HydroSoft® and HydroSoft Plus Embolization Coil Systems to a predicate device (HydroCoil® Embolic System, K070656). The evaluation does not involve acceptance criteria or a study design in the context of an AI/algorithm-driven device's performance against clinical metrics. Instead, it relies on demonstrating similar technical and performance attributes to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria or detailed numerical performance metrics for the device, as it is focused on establishing substantial equivalence based on similarities to a predicate device, not on proving de novo clinical efficacy against predefined thresholds.

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

• Sample Size (Test Set): Not applicable or not specified. A clinical "test set" in the context of a new AI algorithm's performance is not part of this 510(k) submission for an embolization coil.
• Data Provenance: Not applicable or not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or not specified. Ground truth establishment by experts for a test set is relevant for AI/diagnostic algorithms, not for physical medical devices in a 510(k) substantial equivalence submission.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is typically conducted for diagnostic devices (e.g., imaging software) to assess reader performance with and without AI assistance. This document describes a physical neurovascular embolization coil.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No. This is not an AI/algorithm device.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of an AI/algorithm device. For this physical device, the "ground truth" for demonstrating substantial equivalence lies in comparing its material composition, design, and intended use against the legally marketed predicate device, and ensuring that any differences do not raise new questions of safety or effectiveness. This is implicitly established through engineering specifications, material testing, and a comparison of intended uses.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable or not specified. There is no AI algorithm being trained.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment (Training Set): Not applicable.

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Arterial and venous embolization in the peripheral vasculature

This embolization coil system is supplied sterile and is intended for one time use. The device is comprised of an introducer system with a premounted detachable embolization coil. The embolization coil is deployed when the interlocking threads between the coil and the delivery wire are "unscrewed" by turning the delivery wire counterclockwise approximately 25 times.

The introducer system consists of a delivery wire and a delivery wire inserter. The delivery wire inserter consists of a plastic delivery wire holder with the delivery wire and a cannula inserter containing the coil. A Detach Locking Device is also needed to use the set. This part is sold separately because several coils can be delivered through one Detach Locking Device. These components are further described below.

• Coil: The coil is constructed of platinum and is available in the following shapes: curled, straight, Tornado™, J-Coil Shape and Multiple J-Coil Shape. The coil is also available in three degrees of softness: Detach 18® standard, Detach 18® soft, and Detach 110.
• Delivery Wire: The delivery wire is comprised of four components: a handle, the delivery wire, a marker band and a detach tip. These are constructed of platinum and PTFE coated stainless steel. The delivery wires for Detach 11® and Detach 18® are available in a length of 200 cm. The diameter of the Detach 11@ delivery wire is 0.011 inches. The diameter of the Detach 18® delivery wire is 0.018 inches.
• Delivery Wire Inserter: The delivery wire inserter is also comprised of four components. These include a stainless steel tip, a polycarbonate tip fitting, polyethylene tubing and a nylon fitting.
• Detach Locking Device: The Detach Locking Device is basically a pin vise which ensures that the delivery wire does not move forward during coil detachment. This device does not contact the skin or the blood.

The Embolization Coil System (Detach 11® and Detach 18®) was evaluated for safety and effectiveness through a series of tests. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria with numerical targets. However, the tests performed serve to assure reliable design and performance, and successful completion of these tests implies that the device meets the implied acceptance criteria for its intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (Tensile tests, Performance Test). It simply states that Detach 11®/18® "was subjected to the following tests."

• Test Set Sample Size: Not specified.
• Data Provenance: The tests were conducted internally by COOK INCORPORATED ("COOK INCORPORATED was subjected to the following tests"). The country of origin of the data is therefore likely the USA, where Cook Incorporated is based. The nature of the tests (tensile tests, phantom performance tests) indicates they are prospective experimental tests conducted on the device prototypes or production samples.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

It is common for such internal engineering tests to be evaluated by qualified engineers and technical personnel within the company, but specific details are not provided in this regulatory submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

For the types of mechanical and performance tests described, "adjudication" in the sense of a consensus among multiple human reviewers for subjective outcomes is not typically applicable. The results are usually quantitative (e.g., force measurements for tensile tests) or observable functional outcomes (e.g., successful deployment in a phantom). The interpretation of these results against predefined engineering specifications would be handled by the testing personnel.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.

This submission is for a medical device (embolization coil), not an AI or imaging diagnostic tool. MRMC studies are primarily relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret medical images.

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

• Standalone Performance Study: No, a standalone performance study was not done, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Tensile Tests: The "ground truth" would be established by predefined engineering specifications for strength and durability. The device's performance (e.g., ultimate tensile strength, elongation at break) would be measured and compared against these specifications.
• Performance Test in a Microferret™ Catheter Mounted in a Phantom: The "ground truth" would be the successful, unhindered deployment and detachment of the coil within the simulated anatomy. This is a functional assessment against expected operational parameters.

In essence, the ground truth is based on engineering specifications and functional performance criteria for the device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable.

This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. Design and development are based on engineering principles and iterative testing, not by training a model on data.

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

• Ground Truth for Training Set: Not applicable.

As mentioned above, there is no training set for this type of device. The design specifications and performance requirements that guide the device's development are established through engineering analysis, clinical needs assessment, and regulatory standards.

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