(30 days)
The Retracta Detachable Embolization Coil is intended for arterial and venous embolization in the peripheral vasculature.
The Retracta Detachable Embolization Coil is comprised of a fibered platinum embolization coil connected to a delivery wire. The delivery wire is composed of a tapered nitinol mandril soldered to two segments of coiled Inconel wire. The device is packaged in a spiral holder with an attached loading cartridge.
The provided document is a 510(k) summary for a medical device (Retracta Detachable Embolization Coil) and does not describe an AI/ML study. Therefore, most of the questions regarding AI/ML study parameters cannot be directly answered from the given text.
However, based on the Test Data section, I can extract information related to the device's performance criteria and how they were met through various engineering tests.
Here's an attempt to answer your request based on the provided text, while acknowledging the limitations due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Deployment Friction | Not statistically greater than that of the current (predicate) design. | The delivery friction of the proposed design is not statistically greater than that of the current design. (Acceptance criterion met.) |
| Retraction Friction | Not statistically greater than that of the current (predicate) design. | The retraction friction of the proposed design is not statistically greater than that of the current design. (Acceptance criterion met.) |
| Tensile Testing | Statistically greater than the predefined criterion. | The tensile strength of the proposed design of the delivery wire is statistically greater than that of the current design and statistically greater than the predefined criterion. (Acceptance criterion met.) |
| Torque Testing | Number of rotations to failure > 10. | The number of rotations to failure of the proposed delivery wire is statistically greater than that of the current design and greater than 10. (Acceptance criterion met.) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Swine Arterial Model Study | Performance ratings of "adequate" or "good" for all performance parameters. | The proposed design achieved performance ratings of "adequate" or "good" for all performance parameters. (Acceptance criterion met.) |
The requested information primarily pertains to AI/ML device studies. This document, a 510(k) premarket notification, describes a conventional medical device (embolization coil) and its safety and effectiveness testing, which are primarily engineering and animal model tests. As such, the concepts of "test set," "training set," "ground truth" (in the context of image interpretation), "experts for ground truth," "adjudication method," "MRMC study," and "standalone algorithm performance" are not applicable to this submission.
Therefore, the remaining questions cannot be answered from the provided text as they relate to AI/ML specific study designs not present in this regulatory document.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).