MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:

• K Number: K964813
• Device Name: MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
• Manufacturer: MEDICAL ADVANCES, INC.
• Date Cleared: 1997-02-26 ( 89 days)
• Product Code: MOS
• Regulation Number: 892.1000
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging.

Device Description

Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.

AI/ML Overview

This document is a 510(k) summary for a medical device (a Peripheral Vascular Coil for MRI systems) and does not include information about AI/ML device performance or a study design to meet specific acceptance criteria in the way a modern AI/ML submission would.

Therefore, I cannot extract the requested information points as they pertain to AI/ML device performance and testing. This document focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness in the context of hardware (an MRI coil), not software/AI performance for diagnostic tasks.

Here's why the requested information cannot be found:

• No AI/ML Component: The device described is a physical MRI coil. There is no mention of algorithms, artificial intelligence, machine learning, or any software that performs diagnostic analysis.
• Focus on Substantial Equivalence (Hardware): The entire summary is dedicated to proving that this new coil is "substantially equivalent" to an existing, legally marketed predicate device. This means it has the same intended use and technological characteristics without changing the safety or imaging performance parameters of the MRI system it connects to.
• "Acceptance Criteria" are for Safety Parameters: The "acceptance criteria" you might infer from this document are related to maintaining the safety parameters (e.g., maximum static magnetic field, RF power deposition) and imaging parameters (e.g., signal-to-noise ratio, image uniformity) of the existing MRI system when this new coil is attached. It's about ensuring the new coil doesn't degrade or alter the established performance of the MRI system itself, not about the coil achieving a specific diagnostic performance metric.
• No Diagnostic Performance Study: Since the coil doesn't perform diagnostic interpretation, there's no study to evaluate its diagnostic accuracy, sensitivity, specificity, or reader improvement.

If you have a document related to an AI/ML medical device, I would be happy to try and extract that information.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.