(155 days)
The Merit Prelude™ Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/ or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Merit Medical System's Prelude™ Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The device is marketed with and without an appropriately sized guide wire and/ or access needle.
The provided text is a 510(k) Premarket Notification for the Merit Prelude™ Sheath Introducer and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of clinical metrics or AI performance.
This document describes a medical device (a sheath introducer) and its submission for FDA clearance based on substantial equivalence to a predicate device. The "Performance Testing" section states: "Verification and Validation Studies, as identified in the Clinical Risk Assessment, were completed and demonstrated that the modified devices met all of their pre-determined acceptance criteria." However, it does not provide the specific acceptance criteria or the reported device performance in a quantifiable manner (e.g., sensitivity, specificity, accuracy, or other clinical metrics).
Crucially, this is not an AI/ML device, so questions related to AI performance, such as human reader improvement with AI, standalone algorithm performance, training set details, or ground truth establishment for an AI model, are not applicable.
Here's a breakdown of what can be extracted from the provided text, along with explanations for the unanswerable questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| Pre-determined acceptance criteria based on Verification and Validation Studies identified in the Clinical Risk Assessment. | The modified devices met all of their pre-determined acceptance criteria. |
Note: The document does not provide specific quantifiable acceptance criteria (e.g., "burst pressure > X psi", "hemostasis valve leakage
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).