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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 indicated for the 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'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 Stryker Neurovascular'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 ≥ 2mm, 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.

Stryker Neurovascular's 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 modifications described within this Special 510(k) have resulted in 70 new coil sizes to be added to the currently approved Target Coil product family. These 70 new UPNs use the same processes as the current Target Detachable Coil products with the only difference being the addition of a tapering process to taper the profile of a larger primary coil of 0.014 inches prior to assembly with the delivery wire for new coil sizes designated as Target XL Detachable Coils.

The provided 510(k) summary (K123377) describes the modifications made to the Target® Detachable Coils and assesses their substantial equivalence to predicate devices. This submission does not pertain to an AI/ML medical device, but rather to a physical medical device. Therefore, the questions related to AI/ML device performance metrics, such as sensitivity, specificity, F1-score, reader studies, training sets, and ground truth establishment methods for algorithms, are not applicable in this context.

Instead, the acceptance criteria and study focus on establishing the mechanical properties, biocompatibility, and intended use of the modified physical device compared to its predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance (Focus on Substantial Equivalence):

The document does not present a formal table of quantitative acceptance criteria with corresponding performance values for the specific modifications. Instead, the approach is based on demonstrating substantial equivalence to legally marketed predicate devices by verifying that the modified device's characteristics remain within acceptable limits or are comparable to the predicates across various performance aspects.

The overall reported device performance is that the modified Target Detachable Coils were found to be substantially equivalent to the predicate Target Detachable Coils.

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

The document describes several types of testing: functional, MR compatibility, pre-clinical, packaging, shelf-life, and biocompatibility.

• Sample Size for Functional & Packaging Testing: Not explicitly stated with specific numbers (e.g., N=X coils tested for tensile strength). The descriptions indicate "testing to assess" or "verification testing," implying a sufficient number of units were tested to demonstrate compliance and equivalence.
• Sample Size for Biocompatibility Testing: Not explicitly stated by number of samples. This type of testing typically follows established standards (e.g., ISO 10993 series), which specify sample requirements.
• Data Provenance: All testing appears to be prospective as it's conducted to verify the safety and effectiveness of the new coil sizes or modified components before market introduction. The testing was conducted by Stryker Neurovascular as part of their 510(k) submission, likely at their facilities or certified labs. The country of origin of the data is not explicitly stated beyond "Stryker Neurovascular, Fremont, CA. 94538".

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

The concept of "ground truth" as it applies to AI/ML models (e.g., labeling data by experts) does not directly apply here. However, expert involvement is mentioned:

• Design Validation Testing (from K112385): "Design Validation testing in which a physician assessed the new introducer sheath and new retention clip for the ability of the new configuration to: a) protect the finished device, b) provide acceptable introducer sheath friction, c) provide for proper hydration of the finished device within the new introducer sheath, d) enable easy removal of the finished device from the dispenser coil. Physician evaluation also assessed whether the revised DFU was clear, legible and easy to read."
  • Number of Experts: "a physician" (singular).
  • Qualifications: "physician" – implying a medical professional with clinical experience relevant to using such devices. No specific years of experience or subspecialty (e.g., interventional neurologist/radiologist) are detailed.

4. Adjudication Method for the Test Set:

Not applicable in the context of this physical medical device submission. Adjudication methods like 2+1 or 3+1 are typically used in AI/ML studies to resolve discrepancies in expert annotations or diagnoses. Here, the "truth" is established through engineering and biocompatibility testing against predefined specifications and predicate device performance. The physician assessment mentioned above is a qualitative validation by a single expert, not an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is a submission for a physical medical device (detachable coils), not an AI/ML device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted.

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

Not applicable. This is not an algorithm or software-only device. Performance is assessed through physical testing of the device components.

7. The Type of Ground Truth Used:

The "ground truth" (or basis for acceptance) for this physical medical device is established by:

• Compliance with established standards: Mention of ASTM (F2052, 2213, F2182, F2119, D6499-07) and ISO (EN ISO 10993-5:2009, 10993-10:2009, 10993-10:2010, 10993-11:2009, 10993-4:2009, 10993-18:2009) standards for testing.
• Comparison to predicate devices: Demonstrating that the modified device performs comparably to the legally marketed predicates across specified functional, mechanical, and biocompatibility criteria.
• Engineering specifications and design requirements: Functional testing against predetermined specifications (e.g., tensile strength, detachment time).
• Qualitative physician assessment: For aspects like ease of use and device hydration.

8. The Sample Size for the Training Set:

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

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

Not applicable. As there's no training set for an AI/ML model, there's no ground truth to establish for it in this context.

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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

Stryker Neurovascular's (Boston Scientific) 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 Stryker Neurovascular'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. The coils are designed to be delivered and deployed under fluoroscopic guidance. Once placement in the anatomy. is appropriate, the coil is detached from the delivery wire through the use of the battery-operated power supply. This is accomplished by means of an electrolytic reaction where the anode is the delivery wire and the cathode (or ground) is the return electrode. The body's electrolytes serve as an electrolytic carrier between the two electrodes. The cross section of the stainless steel delivery wire and coil junction is designed in such a manner that when current is applied to the wire, the current causes the exposed stainless steel at the junction to dissolve due to electrolysis, which subsequently disconnects the wire from the coil material. The design of coils allows the electrolytic dissolution to occur only in the detachment zone. Once circuitry in the power supply detects coil detachment, the power supply emits audible beeps signaling detachment and the flow of current is halted. Using fluoroscopy, the physician verifies that the coil has detached and removes the delivery wire without disturbing the newly placed coil. In order to achieve optimum occlusion, it is usually necessary to deploy multiple coils at a single embolization site. The coil properties, namely, the secondary coil shape and stiffness, in concert with each other, impact conformability and optimal packing of the coils in the aneurysm sac. These properties help the coil conform to the contours of the space within which it is deployed. It is important that the coil is able to do this without disrupting the rest of the coil mass. In addition, the coil stretch resistance incorporates an element to help it resist stretching or unraveling under the typical forces exerted upon it during deployment and retraction. Stryker Neurovascular's (Boston Scientific) 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 is a 510(k) summary for a medical device (Target Detachable Coils) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, much of the requested information regarding acceptance criteria, study design for AI models, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies is not applicable or not present in this type of submission.

However, I can extract the relevant information from the document as it pertains to the device's verification testing and regulatory acceptance:

1. Table of acceptance criteria and the reported device performance

The document describes "Verification Testing" for the Target Detachable Coils, primarily to demonstrate that modifications do not alter safety or effectiveness, and that the device remains substantially equivalent to predicate devices. The acceptance criteria are implicitly met by successful completion of these tests, which were previously approved for predicate devices (K102672 and K112385).

2. Sample sized 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 exact sample sizes for each test set. The provenance of the data is generally from laboratory testing and pre-clinical animal models (for MR artifact), as well as physician evaluations. This is a 510(k) submission for a physical medical device, not an AI/ML software. Therefore, the concept of "test set" in the context of an AI model does not apply directly. The testing described is primarily in vitro and pre-clinical.

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)

For the "Design Validation testing," the document states "a physician assessed the new introducer sheath and new retention clip." It does not specify the number of physicians or their specific qualifications (e.g., number of years of experience, specialty). It refers to "Boston Scientific's Corporate Toxicology group" for assessing the new grade stainless steel, but no specific number or detailed qualifications. Given this is a physical device, the "ground truth" for functional and biocompatibility tests is based on established engineering and biological standards, not expert consensus as in image interpretation.

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

The document does not describe any adjudication method. The testing involves physical and chemical property verification, and physician assessment, but not a process that would typically require adjudication as seen in clinical trials or AI model validation where multiple readers provide 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

No such MRMC comparative effectiveness study was done or is applicable. This submission is for a physical medical device (detachable coils), not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This is for a physical medical device.

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

The "ground truth" for the verification testing described is primarily based on:

• Established engineering standards (e.g., ASTM standards for MR compatibility, tensile strength measurements).
• Biocompatibility standards (e.g., EN ISO 10993 series).
• Pre-clinical animal model observations (for post-implant MR artifact and assessment in coiled aneurysm models).
• Physician qualitative assessment for usability and protection of the device.

8. The sample size for the training set

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

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

Not applicable, as there is no training set for an AI/ML model for this device.

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