(29 days)
The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.
The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.
This document is a 510(k) premarket notification for a medical device, specifically a 48CH Head Coil for MRI systems. The FDA letter and the 510(k) summary provided indicate that this device is being submitted as substantially equivalent to a previously cleared predicate device (48CH Head Coil, K163205).
Key takeaway: The regulatory submission explicitly states that clinical studies were not required to support substantial equivalence for this device. This means the information requested about acceptance criteria, detailed study design (sample size for test/training sets, number of experts, adjudication, MRMC, standalone performance, ground truth establishment) is largely not applicable in the context of this specific 510(k) submission.
The submission focuses on non-clinical testing to demonstrate that the device is as safe and effective and performs in a substantially equivalent manner to the predicate, despite a minor design change (decoupling circuit).
Therefore, I cannot provide the requested information about acceptance criteria for a clinical study or a detailed study description because the submission states that no clinical studies were performed or required.
Here's what can be extracted and inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study" for this specific type of submission:
Acceptance Criteria and Study for Substantial Equivalence (Non-Clinical Focus)
Since this 510(k) relies on substantial equivalence established through non-clinical testing, the "acceptance criteria" are not for clinical performance metrics (like sensitivity/specificity of an AI algorithm), but rather for demonstrating that the new device performs equivalently to the predicate in terms of safety and technical specifications.
1. Table of "Acceptance Criteria" and "Reported Device Performance" (Non-Clinical Context):
| Acceptance Criterion (Implied) | Reported "Device Performance" (from 510(k) Summary) |
|---|---|
| Functional Equivalence: Device performs its intended use reliably and effectively. | "The 48CH Head Coil device performs as intended." |
| Safety Compliance: Device meets recognized safety standards. | "The predicate and modified devices have been subject to the same risk management testing to demonstrate substantial equivalence of safety and performance." |
| "Testing included: AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 MS6-2008 Maximum B1 Peak Blocking Network Analysis Surface Temperature Testing" | |
| "The 48CH Head Coil complies with the same safety and performance testing as the predicate device." | |
| Technical Equivalence: Core technology and operational principles are the same as the predicate. | "The 48CH Head Coil employs the same fundamental scientific technology as its predicate device." |
| "Coil Design: The 48CH Head Coil design is the same as the predicate device but implements a design change to the decoupling circuit." (Acknowledged difference, but deemed not to raise new safety/effectiveness questions). | |
| "Operating Principles: The 48CH Head Coil operates on the same principles as the predicate device." | |
| "Materials: The 48CH Head Coil uses the same materials as the predicate device." | |
| Intended Use Equivalence: Indications for Use are identical to the predicate. | "The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen." |
| "The intended use statements are identical [to the predicate]." |
2. Sample Size Used for the "Test Set" and Data Provenance:
- Not Applicable. No clinical test set data was reported as part of this 510(k) submission. The testing performed was non-clinical (e.g., electrical, thermal, mechanical bench testing).
- The document explicitly states: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence."
3. Number of Experts Used and Qualifications:
- Not Applicable. No clinical ground truth was established by experts for a test set, as no clinical study was performed or required.
4. Adjudication Method:
- Not Applicable. No clinical test set to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. No clinical study comparing human reader performance with or without AI assistance was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic algorithm.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. This device is an MRI coil, not a standalone algorithm.
7. Type of Ground Truth Used:
- Not Applicable for clinical ground truth. For the non-clinical testing, the "ground truth" would be established engineering specifications, safety standards (e.g., IEC 60601 series), and performance metrics of the predicate device against which the new device was compared (e.g., signal-to-noise ratio measurements, temperature limits, B1 field uniformity targets).
8. Sample Size for the Training Set:
- Not Applicable. This device is an MRI coil, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set exists for this type of device.
In summary, the provided document clearly states that this 510(k) submission for the 48CH Head Coil did not require clinical studies to demonstrate substantial equivalence, relying instead on non-clinical testing. Therefore, the detailed questions related to clinical study design, data, experts, and ground truth are not applicable to the information contained within this regulatory filing.
§ 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.