Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)

• K Number: K143252
• Device Name: Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
• Manufacturer: NEEDLETECH PRODUCTS, INC.
• Date Cleared: 2015-04-23 ( 161 days)
• Product Code: DQX
• Regulation Number: 870.1330
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K040498 , K910969

Intended Use

The QuikTork guide wire torque device is intended to facilitate guide wire interventional procedures.

Device Description

The QuikTork torque device is designed and intended to be used for the manipulation and placement of guide wires used during interventional procedures. The QuikTork device is not body contacting as the device is used by threading the guide wire end, which is outside the body, through the device lumen to provide an easier grip for manipulation of the guide wire. Once the guide wire is positioned, the QuikTork is removed. The device consists of one piece of molded polyoxymethylene, and is yellow or orange depending on the diameter of the guide wire that will be used with the device. The yellow device supports guide wire diameters 0.010 to 0.020 inches, and the orange device supports guide wire diameters 0.025 to 0.040 inches.

AI/ML Overview

This document describes the QuikTork Torque Device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification from the FDA for a medical device called the "QuikTork Torque Device," which is a manual tool used to manipulate guide wires in interventional procedures. It is not an AI-powered device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them, as the provided input does not describe an AI device or a study of its performance against acceptance criteria.

To answer your request, I would need a document that describes:

1. An AI-powered medical device.
2. Specific acceptance criteria for that AI device.
3. A study evaluating the performance of that AI device against those criteria, including details on sample size, data provenance, ground truth establishment, expert involvement, and study design (standalone vs. MRMC).

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.