FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

Device Description

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.

AI/ML Overview

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.

Summary

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Test	Test Method Summary/Purpose	Acceptance Criteria	Reported Device Performance
Delivery Wire Tensile Strength	Determine the force at break at bond joints for delivery wire via tensile testing.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Proximal Contact Buckling	Determine the maximum buckling force to kink the proximal contact.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Proximal Contact Tensile Strength	Determine the maximum tensile force to break the proximal contact joint.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Coil Detachment	Measure coil detachment time in bovine serum using the InZone Detachment System.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Biocompatibility	MEM Elution Cytotoxicity, Hemolysis Direct/Extract Contact, USP Physicochemical USP , FTIR, Natural Rubber Latex, ELISA Inhibition Assay for Antigenic Protein ASTM D6499-12.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Packaging	Assess the ability of the packaging system to protect the finished device.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Simulated Use	Detachment unit compatibility with coil, Introducer sheath friction acceptability, Removal of coil from the packaging hoop without damaging the device.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - Magnetically induced displacement	ASTM F2052	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - Magnetically induced torque	ASTM F2213	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - Magnetically induced heating effect	ASTM F2182	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - MR induced image artifact	ASTM F2119	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - Magnetically induced displacement	ASTM F2052	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - Magnetically induced torque	ASTM F2213	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - Magnetically induced heating effect	ASTM F2182	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - MR induced image artifact	ASTM F2119	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.