(113 days)
The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.
The Aptus 18Fr HeliFX Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the 18Fr HeliFX Applier, and the 18Fr HeliFX Guide.
This 510(k) summary describes a medical device, the Aptus 18Fr HeliFX Aortic Securement System, and states its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of accuracy or efficacy against a defined ground truth, especially not in the context of an AI/ML algorithm.
Here's why and what information is missing:
- No AI/ML Algorithm: The document describes a physical medical device (an endovascular suturing system) for mechanical fixation and sealing of aortic grafts. It is not an AI/ML powered device. Therefore, concepts like AI performance, test sets, training sets, ground truth establishment by experts, adjudication, or MRMC studies do not apply.
- Focus on Substantial Equivalence: The primary goal of this 510(k) summary is to demonstrate that the new Aptus 18Fr HeliFX Aortic Securement System is "substantially equivalent" to a previously cleared predicate device (Aptus HeliFX Aortic Securement System per K102333). This typically involves showing similar materials, method of operation, and intended use, and that any differences do not raise new questions of safety or effectiveness.
- "Data Relied Upon" is Different: The "Data relied upon for substantial equivalence" section lists performance and simulated use testing, mechanical integrity testing, endograft compatibility testing, sterilization, biocompatibility, and shelf-life evaluations. These are standard engineering and biological tests for a physical medical device, not performance metrics for an AI algorithm.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and AI/ML performance because the provided document does not pertain to an AI/ML device and does not contain that type of information.
§ 870.3460 Endovascular Suturing System.
(a)
Identification. An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device should be demonstrated to be biocompatible;
(2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment;
(4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment;
(5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety;
(6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and
(7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.