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Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Detachable Coils are indicated for endovascular embolization of:

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

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately).

Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils in the 360-shape, the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.

The Stryker Neurovascular InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

This document, K161429, concerns the 510(k) premarket notification for Stryker Neurovascular Target Detachable Coils, specifically the new Target XXL 360 Detachable Coils. The submission aims to demonstrate substantial equivalence to previously cleared Target Detachable Coils.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "Verification Testing" to demonstrate substantial equivalence. The acceptance criteria for the new Target XXL 360 Detachable Coils are explicitly stated as meeting the same criteria as the predicate device for each test. The reported device performance is that the new coils Met the same criteria as the predicate device.

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 does not specify the sample size used for the test set for any of the verification tests. It also does not provide information on the data provenance, such as country of origin or whether the data was retrospective or prospective. The tests described are laboratory-based engineering and material testing, not clinical studies involving human patients or 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 applicable and not provided in the document. The "ground truth" in this context refers to the defined engineering and material properties acceptable within the product specifications, not to clinical diagnoses or interpretations by medical experts. The tests are designed to measure physical and chemical properties against established internal specifications, which likely involve engineering standards and regulatory requirements.

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving observer variability in assessments (e.g., image interpretation). The verification tests performed are objective, measurable physical and chemical tests, not requiring human adjudication.

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

An MRMC comparative effectiveness study was not conducted. This document describes the clearance of a medical device (detachable coils) based on substantial equivalence through engineering and material testing, not an AI or imaging diagnostic device. Therefore, questions regarding human reader improvement with or without AI assistance are not applicable.

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

A standalone performance study for an algorithm was not conducted. This document pertains to the clearance of a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the verification tests performed is based on defined engineering specifications, material properties, and regulatory standards for similar predicate devices. The acceptance criteria are "the same criteria as the predicate device," indicating that the "truth" is established by the performance and specifications of previously cleared, substantially equivalent devices. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but from established physical and performance benchmarks for the device type.

8. The sample size for the training set

This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set." The coils are physical devices validated through engineering tests.

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

This information is not applicable and not provided. As there is no "training set" in the context of this device clearance, the method of establishing its ground truth is irrelevant.

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Target Detachable Coils are indicated for endovascular embolization of:

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

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano Target Helical Nano Target XL 360 Soft Target 360 Ultra Target Helical Ultra Target XL 360 Stand Target 360 Soft Target XL Helical Target 360 Standard Target 3D All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils in the 360-shape, the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops. The Stryker Neurovascular InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The provided document describes the verification testing conducted for the Stryker Neurovascular Target Detachable Coils, focusing on demonstrating substantial equivalence to a predicate device after minor design modifications. It does not contain information about an AI-powered device or a study involving human readers and AI assistance. Therefore, it is not possible to answer all categories of your request comprehensively. However, I can extract the relevant information from the document as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of an algorithm or AI model development. Instead, it describes various engineering and material tests performed on the physical device. The sample sizes for each specific test (e.g., number of coils for tensile strength, number of detachment tests) are not explicitly stated. The data provenance is related to in-house testing by Stryker Neurovascular.

3. 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 the document describes validation of a physical medical device, not an AI-powered diagnostic or decision-support system. Ground truth in this context refers to established engineering standards and performance targets.

4. Adjudication method for the test set

Not applicable. The testing described involves objective measurements and adherence to specified criteria rather than expert adjudication of interpretations.

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 pertains to the regulatory submission for a physical neurovascular embolization device, not an AI-powered medical device or software.

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

Not applicable. This document is about a physical medical device.

7. The type of ground truth used

For the engineering tests (tensile strength, buckling, detachment, packaging, simulated use), the "ground truth" or reference for acceptance was meeting the same criteria as the predicate device, implying adherence to established performance specifications for such devices.

For biocompatibility, the ground truth was meeting established criteria for biocompatibility tests (MEM Elution Cytotoxicity, Hemolysis, USP Physicochemical, FTIR, Natural Rubber Latex, ELISA Inhibition Assay).

For MRI testing, the ground truth was meeting the criteria specified in the referenced ASTM standards (F2052, F2213, F2182, F2119) and demonstrating performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as 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.

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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Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Target Coils are indicated for endovascular embolization of:

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

Boston Scientific Corporation's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Boston Scientific's InZone Detachment System (sold separately).

Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.

Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

On September 15, 2010 Boston Scientific submitted a Special 510(k) for modification of the grade of stainless-steel for two components of the finished device: 1) the stainless-steel wire sub-assembly and 2) the etched link component.

The stainless-steel wire sub-assembly is a component of the delivery wire to which the main coil is attached. During assembly, the wire is placed coaxially through the lumen of a coil-hypotube assembly. The etched link component joins the delivery wire to the main coil.

The modification was made to minimize magnetic resonance imaging (MRI) artifact during follow-up MRI.

The provided document describes the predicate devices and modifications made to the Target Detachable Coils, which are used for embolization of intracranial aneurysms and other vascular abnormalities. The document focuses on demonstrating substantial equivalence to predicate devices through various verification tests rather than presenting a study with specific acceptance criteria and detailed device performance results in a comparative format.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to product modifications, safety and effectiveness testing, and regulatory clearance.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

The document does not present a formal table of acceptance criteria with corresponding performance statistics. Instead, it lists the types of verification testing performed to demonstrate substantial equivalence to the predicate device after a modification to the stainless steel grade in two components. The "performance" is generally stated as the tests demonstrating substantial equivalence or successful completion.

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

The document does not explicitly state the sample sizes for the test sets in the verification testing. The tests conducted are primarily engineering/performance tests (e.g., tensile strength, detachment time, MR compatibility) and biocompatibility tests, rather than clinical studies with human patient data.

• Sample Size: Not specified for any of the verification tests.
• Data Provenance: Not specified, but likely from laboratory testing (functional, MR compatibility, biocompatibility) and pre-clinical animal models (for post-implant MR artifact data and aneurysm models). It is not human clinical data, and thus country of origin or retrospective/prospective nature is not applicable in the context of this submission.

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 because the tests performed are primarily laboratory and pre-clinical evaluations, not assessments requiring expert "ground truth" establishment in a diagnostic or clinical interpretation context.

4. Adjudication method for the test set

Not applicable, as the tests performed are objective measurements (e.g., tensile strength values, detachment times, MR signal characteristics) rather than subjective assessments requiring adjudication.

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

Not applicable. This submission concerns a physical medical device (detachable coils for embolization) and modifications to its material, not an AI-assisted diagnostic tool.

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

Not applicable, as this is not an algorithm or AI system.

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

For the functional and MR compatibility tests, the "ground truth" would be the established engineering specifications and test standards (e.g., ASTM standards). For biocompatibility, it would be the biological response criteria. For pre-clinical aneurysm models, it would be direct observation or imaging of the embolization outcomes in the animal model. This is not derived from expert consensus, pathology, or human outcomes data in the context of this submission.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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