(164 days)
The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively.
The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a cardiac introducer sheath and primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's why I cannot provide the requested information:
- No Acceptance Criteria or Performance Study: The document does not mention any specific quantitative acceptance criteria for device performance, nor does it describe any study (clinical or analytical) designed to prove the device meets such criteria.
- Focus on Substantial Equivalence: The content outlines the device's description, its intended use, and a comparison to a predicate device, concluding that it is "substantially equivalent." This type of submission relies on demonstrating the new device is as safe and effective as a legally marketed predicate, rather than detailing novel performance studies against specific acceptance metrics.
- Lack of AI-Related Information: All the specific questions you've asked (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are highly relevant to the evaluation of AI/ML-driven medical devices. This document describes a physical medical device (introducer sheath) and does not involve any AI components.
Therefore, providing a table of acceptance criteria and reported device performance, or details about studies involving test sets, training sets, experts, or AI performance, is not possible from this document.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).