(74 days)
The FARADRIVE Sheath is intended for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.
The FARADRIVE Steerable Sheath is used to facilitate access to the vasculature and into the chambers of the heart. The handle is furnished with a rotating Actuator Knob that enables a single plane unidirectional deflection and has the ability to actively straighten the distal end of the FARADRIVE Steerable Sheath curve when rotated.
The FARADRIVE Steerable Sheath includes an integral hemostasis valve to minimize blood loss or air ingress during catheter and dilator manipulation and a side flush line with three-way stopcock for blood aspiration, fluid infusion, blood sampling and pressure monitoring. The sheath also includes distal vent holes to facilitate aspiration and minimize cavitation. The supplied dilator is shaped to assist in facilitating vascular or chamber access when fully inserted into the sheath. The proximal end of the dilator includes a feature that will lock to the sheath hub when fully inserted.
The provided text is a 510(k) summary for the FARADRIVE™ Steerable Sheath. This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance testing. It does not describe a study involving an algorithm or AI, nor does it establish ground truth with experts or involve human readers.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving a device meets acceptance criteria using an AI/algorithm-based evaluation. The available information pertains to the regulatory clearance of a medical device (a steerable sheath), not a diagnostic algorithm.
Specifically, the document details physical and performance characteristics of the FARADRIVE™ Steerable Sheath and compares them to a predicate device (POLARSHEATH™ Steerable Sheath 12F) to establish substantial equivalence for regulatory approval.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No AI/Algorithm: The submitted device, FARADRIVE™ Steerable Sheath, is a physical medical device (a catheter sheath), not an AI or algorithm-based diagnostic tool.
- No "Test Set" or "Training Set": These terms are relevant to machine learning studies. The "test set" mentioned in the document refers to performance testing of the physical device per design specifications, not an image or data set used for evaluating an algorithm.
- No "Ground Truth" by Experts: The "ground truth" concept is typically used to establish the correct diagnosis or finding in data used for training/testing AI. This document does not describe such a process.
- No "MRMC Comparative Effectiveness Study": This type of study compares the diagnostic performance of human readers with and without AI assistance. This is not applicable to a physical steerable sheath.
- No "Standalone Performance": "Standalone performance" refers to the algorithm's performance without human intervention. Again, this is not relevant to a physical device.
What the document does provide is a summary of non-clinical performance testing for a physical device:
The "Summary of Non-Clinical Performance Testing" on page 8 confirms that the testing aimed to show the device "conforms to user needs and its intended use and is thus substantially equivalent to the predicate." The listed tests include:
- Sterilization validation
- Biocompatibility assessment
- Design verification testing (at nominal and accelerated aging timepoints)
- Design validation testing summary for the FARAPULSE Pulsed Field Ablation System (presumably to show compatibility or a larger system context, not a performance study of the sheath itself)
These tests are standard for physical medical devices to ensure they meet safety and performance requirements, but they do not involve the concepts of AI, algorithms, ground truth, or expert readers as outlined in your request.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).