(71 days)
Magnetic resonance imaging (MRI) of the hand and wrist.
Model 445PH-64 Quadrature Wrist Coil. Compatible with Philips Gyroscan ACS-NT 1.5T MRI system.
This document describes the 510(k) summary for the Medical Advances, Inc. Model 445PH-64 Quadrature Wrist Coil, submitted on April 21, 1999 (K991434). This device is a Magnetic Resonance Imaging (MRI) coil intended for diagnostic imaging of the hand and wrist.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this submission are framed around demonstrating substantial equivalence to the predicate device (the Philips Gyroscan ACS-NT 1.5T MRI system operated without the Medical Advances Quadrature Wrist Coil). The key performance parameters are assessed by showing "No change" compared to the predicate device, indicating that the addition of the new coil does not adversely affect these fundamental MRI system capabilities. No specific quantitative numerical acceptance thresholds are provided in this summary.
| Acceptance Criteria Category | Specific Parameter | Reported Device Performance (with Medical Advances Quadrature Wrist Coil) |
|---|---|---|
| Safety Parameters | Maximum Static Magnetic Field | No change |
| Rate of Magnetic Field Strength Change | No change | |
| RF Power Deposition | No change | |
| Acoustic Noise Levels | No change | |
| Imaging Performance | Specification Volume | No change |
| Signal-to-Noise Ratio | No change | |
| Image Uniformity | No change | |
| Geometric Distortion | No change | |
| Slice Thickness and Gap | No change | |
| High Contrast Spatial Resolution | No change | |
| General Safety and Effectiveness | Instructions for Use (Indications, Precautions, Cautions, Contraindications, Warnings, QA Testing) | Device includes these to assure safe and effective use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a separate "test set" in the context of clinical studies with human subjects or detailed performance evaluations for the Quadrature Wrist Coil. The submission relies on demonstrating that the new coil, when integrated with an existing, legally marketed MRI system (Philips Gyroscan ACS-NT 1.5T), does not alter the system's safety and imaging performance parameters.
The data provenance is implied to be from engineering and technical testing of the coil's compatibility and performance characteristics within the specified MRI system, rather than a clinical study with patient data. No information on country of origin or whether it's retrospective/prospective is given, as it's not a clinical data-driven submission in the modern sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the nature of the submission, which focuses on demonstrating substantial equivalence through technical specifications rather than clinical diagnostic accuracy, no information is provided regarding experts used to establish ground truth for a test set. This type of submission does not involve a diagnostic accuracy study where ground truth would be established by medical experts for a set of cases.
4. Adjudication Method for the Test Set
As there is no specified test set involving human subject data or diagnostic interpretations, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed by the device manufacturer, as this submission is for an MRI coil and focuses on technical equivalence rather than comparing diagnostic efficacy with and without AI assistance. The device itself is an accessory to an MRI system, not an AI-enabled diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done as the device is a passive MRI coil and does not incorporate an algorithm that operates independently.
7. Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety specifications of the predicate Philips Gyroscan ACS-NT 1.5T MRI system when operating without the Medical Advances Quadrature Wrist Coil. The new coil is demonstrated to not alter these established parameters. This is based on technical specifications and engineering measurements rather than expert consensus, pathology, or outcomes data from a diagnostic study.
8. Sample Size for the Training Set
There is no mention of a training set as this device is a passive MRI coil and does not employ machine learning or AI algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
§ 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.