(88 days)
The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system.
The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Shoulder and other related joint structures Anatomic Regions:
Nuclei Excited: Hydrogen
The Picker Phased Array Shoulder Coil is a receive-only coil designed to provide imaging of the shoulder and other joint structures. The coil is designed to give improved signalto-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil.
This document describes a medical device, the Phased Array Shoulder Coil, and asserts its substantial equivalence to a predicate device. However, it does not contain the type of study data, acceptance criteria, or performance metrics typically associated with AI/ML device evaluations.
Instead, this document focuses on comparing a new MRI coil (a hardware accessory) to a previously cleared MRI coil. The determination of "safety and effectiveness" is based on showing that the new coil is "substantially equivalent" to an existing, legally marketed device (the predicate device) in terms of its design, materials, and intended use, rather than demonstrating performance against specific clinical metrics.
Therefore, many of the requested categories for AI/ML device studies are not applicable to the information provided in this document.
Here's an analysis based on the provided text, highlighting what is and is not present:
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Phased Array Shoulder Coil) |
|---|---|---|
| Intended Use | Same as predicate device (MAI Phased Array Shoulder Coil: receive only antenna of RF energy, signal dependent on MRI parameters, images correspond to nuclei distribution, indicated for shoulder and related joint structures, Hydrogen nuclei excited). | "The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system." "Indicated for use in the following anatomic regions and with the designated nuclei: Shoulder and other related joint structures, Nuclei Excited: Hydrogen." (This matches the predicate's intended use.) |
| Compatible MRI Systems | Must be compatible with an MRI system; specific system for predicate is GE 1.5 T Signa. | Picker International 1.5 T EDGE |
| Mode of Operation | Same as predicate device (Receive-Only Array). | Same (Receive-Only Array) |
| Antenna Configuration | Same as predicate device (Multi-channel Array). | Same (Multi-channel Array) |
| Tuning/Impedance Matching | Same as predicate device (Fixed tuning and matching, Factory set). | Same (Fixed tuning and matching, Factory set implied by "Same") |
| Method of Decoupling | Same as predicate device (Passive diode decoupling). | Same (Passive diode decoupling implied by "Same") |
| Coil Enclosure | Same as predicate device (Flame rated thermoplastic enclosure and vinyl pads). | Same (Flame rated thermoplastic enclosure and vinyl pads implied by "Same") |
| Number of Receive Channels | Same as predicate device (Four). | Same (Four) |
| Performance (general) | Improved Signal-to-Noise Ratio (SNR), image resolution, and image acquisition time over the Body Coil. | Claims "improved signal-to-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil." (No quantitative data provided to substantiate this claim for the substantial equivalence comparison). |
Note: The "acceptance criteria" here are implied by the substantial equivalence framework – the new device must be sufficiently similar to the predicate device in terms of design, operation, and intended use as not to raise new questions of safety or effectiveness. There are no explicit quantitative performance metrics or user study results presented to prove specific performance targets were met. The claim of "improved SNR, image resolution and image acquisition time" is a design goal statement, not a quantified performance result relative to the predicate or a specific benchmark in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A). This document does not detail a clinical study with a "test set" in the context of AI/ML validation. The "study" is a comparison of technical specifications and intended use to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. No expert ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This device is an MRI coil, not an AI/ML algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is an MRI coil, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. The assessment is based on a comparison of device specifications and intended use to a predicate device, not on clinical ground truth data from specific diagnostic cases.
8. The sample size for the training set
- N/A. This product is an MRI coil and does not involve AI/ML training.
9. How the ground truth for the training set was established
- N/A. This product is an MRI coil and does not involve AI/ML training or ground truth establishment in this context.
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SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
1. General Information
| Classification: | Class IIMagnetic Resonance Imaging (MRI) Accessory |
|---|---|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Phased Array Shoulder Coil |
| Establishment Registration: | Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965 |
| Performance Standards: | Not Applicable |
2. Intended Uses
The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system.
The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Shoulder and other related joint structures Anatomic Regions:
Nuclei Excited: Hydrogen
{1}------------------------------------------------
3. Device Description
The Picker Phased Array Shoulder Coil is a receive-only coil designed to provide imaging of the shoulder and other joint structures. The coil is designed to give improved signalto-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil.
4. Safety and Effectiveness
The Picker Phased Array Shoulder Coil is substantially equivalent in safety and effectiveness to the MAI Phased Array Shoulder Coil for the GE 1.5 T Signa system. The following chart has been compiled to demonstrate the Shoulder Coil's substantial equivalence to this device.
| Parameter | Phased Array Shoulder Coil | Predicate DeviceMAI Phased Array ShoulderCoil (K945778) |
|---|---|---|
| Compatible MRI Systems | Picker International 1.5 TEDGE | GE 1.5 T Signa with PhasedArray Hardware Option |
| Mode of Operation | Same | Receive-Only Array |
| Antenna Configuration | Same | Multi-channel Array |
| Tuning/Impedance Matching | Same | Fixed tuning and matching.Factory set. |
| Method of Decoupling | Same | Passive diode decoupling. |
| Coil Enclosure | Same | Flame rated thermoplasticenclosure and vinyl pads. |
| Number of Receive Channels | Same | Four |
| Parameter | Phased Array Shoulder Coil | Predicate DeviceMAI Phased Array ShoulderCoil (K945778) |
| Intended Use | The MAI Phased Array Shoulder Coil is indicated for use as areceive only antenna of RF energy at a specific frequency. Thesignal received by the coils is dependent upon MRI parameters(T1 or spin-lattice relaxation time, T2 or spin-spin relaxationtime, density of nuclei, flow velocity, and chemical shift). Theimages produced by the imaging coil correspond to thedistribution of nuclei exhibiting nuclear magnetic resonance.The MAI Phased Array Shoulder Coil is indicated for use in thefollowing anatomic regions: shoulder and other related jointstructures.The Phased Array Shoulder Coil does not change the intended | |
| The Phased Array Shoulder Coil is indicated for use in thefollowing anatomic regions and with the designated nuclei: | ||
| Anatomic Regions: | Shoulder and other relatedjoint structures. | |
| Nuclei Excited: | Hydrogen |
The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Shoulder and other related joint structures Anatomic Regions:
Nuclei Excited: Hydrogen
{2}------------------------------------------------
PICKER INTERNATIONAL, INC.
(PASC) 8/19/96
§ 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.