(196 days)
The Nova Medical 3T 32 Channel Head Coil is to be used in conjunction with a Magnetic Resonance (MR) Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
Model # 3832016 is used with GE 3T MRI Scanner Discovery MR750.
Model # 38320169 is used with GE 3T MR Scanners Signa Architect, Discovery MR750W and Signa PET/MR.
The Nova Medical 3T 32 Channel Head Coil is receive only MR coil for imaging the human head when used with GE Healthcare 3T MR Systems. The head coil has 32 RF elements that are tuned to 127.75 MHz. The head coil is constructed of a two part rigid plastic housing with an opening for patient viewing and comfort. The 3T 32 Channel Head Coil comprises a split design for easy patient positioning, measures approximately 17.5" long x 12″ high x 15″ wide without the tray and has an approximate weight of 20 lbs. The device comes with optional accessories; Mirror for patient viewing and Foam Cushions for patient comfort and head positioning.
The provided text describes a 510(k) summary for the "3T 32 Channel Head Coils." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical acceptance criteria for diagnostic performance.
Therefore, many of the requested details, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets, are not applicable to this type of submission.
The acceptance criteria and performance data provided are related to the safety and engineering characteristics of the head coil, ensuring it functions as intended and is safe for use in conjunction with an MRI scanner.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Requirements, National/International Standards) | Reported Device Performance |
|---|---|
| Biocompatibility testing per ISO 10993-1 | Passed |
| Electrical safety testing per IEC 60601-1 | Passed |
| Electrostatic discharge testing per IEC 61000-4-2 (per IEC 60601-1-2) | Passed |
| Safety & essential performance of magnetic resonance equipment per IEC 60601-2-33 | Passed |
| Magnetic Resonance Diagnostic Devices Testing per NEMA MS 6 | Passed |
| Transport Testing per ISTA Procedure 2B | Passed |
| Performance Testing (Internal, design & development process) | Results deemed acceptable |
| Clinical Image Quality | Acceptable Image Quality |
Regarding the other requested information:
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The performance testing described relates to engineering and safety standards, not a clinical diagnostic performance test on a specific patient dataset.
- Data Provenance: Not applicable for a clinical diagnostic test set. The clinical images obtained were to demonstrate acceptable image quality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable for a diagnostic performance ground truth.
- Qualifications: "A Chief Medical Physicist" certified the acceptable image quality of the clinical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no diagnostic test set requiring adjudication in this submission.
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:
- No. This submission is for an MRI head coil, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an MRI head coil, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and safety tests, the "ground truth" is adherence to established national and international standards (e.g., ISO, IEC, NEMA).
- For clinical images, the "ground truth" was an assessment of acceptable image quality by a Chief Medical Physicist. This is a technical assessment of image integrity, not a diagnostic accuracy ground truth.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of an AI/machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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.