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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, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra. All Target Coils are stretch resistant coils. Target Coils incorporate a length of monofilament stretch resistant fiber or in the case of the Target Tetra, 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sampling sizes, ground truth establishment, or clinical study results for the Target Detachable Coils.

The document appears to be a 510(k) premarket notification for the consolidation of instructions for use and patient information leaflets, along with other minor changes, for existing Target Detachable Coils. It asserts that the modifications do not alter the intended use, indications for use, or fundamental scientific technology of the predicate devices. Therefore, a comparative clinical study is not detailed here.

The document states:

• "This 510(k) requests clearance for the consolidation of three separate Target Instructions for Use (IFUs) into a single shared IFU and consolidates two separate Target Patient Information Leaflet (PIL) with Patient Information Card (PIC), making it a single PIL with PIC for all Target Detachable Coils, in addition to other changes made since the last 510(k) clearance resulting in a cumulative assessment that a new 510(k) is required."
• "The subject devices utilize the same design and materials of existing Target Coils, and the same manufacturing, packaging and sterilization processes."
• "The modified Stryker Neurovascular Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils. The modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the Predicate Devices."
• "Because the subject modifications do not alter the intended use or indications for use of the predicate devices, or the fundamental scientific technology of the predicate devices; and because the risk assessment of the modifications raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate device."

Therefore, the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.

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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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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'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.

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.

The provided text describes Boston Scientific Corporation's Target Detachable Coils and InZone Detachment System. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not present in the provided document.

However, based on the available information, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it states that "Verification testing has demonstrated Target Detachable Coils are substantially equivalent to the current legally marketed predicate devices" and similarly for the InZone Detachment System, electrical safety testing "has demonstrated the devices to be substantially equivalent to the current legally marketed predicate device."

The "performance" reported is that the devices are substantially equivalent to their respective predicate devices. This implies that their performance, in terms of safety and effectiveness for their intended use, is considered comparable to already approved devices.

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

The document states "Verification testing has demonstrated..." and "Verification testing of the InZone Detachment System, including electrical safety testing in accordance with applicable parts of the EN 60601-series of standards, has demonstrated..."

This indicates that pre-clinical verification testing was performed. However, specific sample sizes for these tests are not provided. The data provenance is also not specified, but given this is pre-clinical bench and electrical safety testing, it would largely be laboratory-generated data, not human patient data in the context of geographical origin or retrospective/prospective nature.

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

This information is not provided and is generally not applicable to a 510(k) submission for this type of device, which relies heavily on bench testing and comparison to predicate devices, rather than human expert evaluation of clinical cases or images.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable in the context of the reported verification testing.

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 (embolization coils and their detachment system) is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.

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.

7. The Type of Ground Truth Used:

For the "verification testing," the ground truth implicitly used would be established engineering specifications, performance standards (like EN 60601 for electrical safety), and the known characteristics/performance of the predicate devices. For example, if testing tensile strength, the "ground truth" would be the specified strength range for safe performance.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.

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

This information is not provided and is not applicable for the same reason as point 8.

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