(20 days)
The Millennium III 4 Channel Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest in Magnetic Resonance Imaging Systems. The Millennium III 4 Channel Neurovascular Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.
Indications for Use: The Millennium III 4 Channel Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 4 Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.
Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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 Millennium III 4 Channel Neurovascular Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided text is a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the Millennium III 4 Channel Neurovascular Coil. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria for a diagnostic algorithm.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness will not be found in this document, as it pertains to a physical medical device (an MRI coil) and not a diagnostic AI algorithm.
However, I can extract the information that is present and indicate where information is not applicable or not provided.
Here's an analysis of the provided text based on your request:
Acceptance Criteria and Device Performance
Since this is a physical MRI coil, the "acceptance criteria" and "device performance" are typically related to its physical characteristics, safety, and imaging capabilities in comparison to a predicate device, rather than diagnostic accuracy metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance and Comparison to Predicate |
|---|---|
| Intended Use | Acceptance: To obtain diagnostic images of the brain, cervical spine, soft tissues, and vasculature of the head, neck, and upper chest in MRI systems. |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - The intended use is directly stated as Imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. | |
| Indications for Use | Acceptance: Identical to routine MRI imaging, specifically for GE 3.0T scanner. Images should correspond to proton distribution, depend on NMR parameters (T1, T2, proton density), and display soft tissue structure, providing information useful for diagnosis when interpreted by a trained physician. |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - Stated as "Identical to routine MRI imaging." | |
| Coil Enclosure Material | Acceptance: Fire rated with high impact and tensile strength, made of specified flame retardant materials. |
| Performance: "Similar to the Alpha 5000 Wrist coil manufactured by USA Instruments, Inc. (K031143)" - Materials include Flame Retardant Polyurethane, Flame Retardant Polycarbonate, Delrin Acetal. | |
| Coil Design | Acceptance: Multi-element phased array receive-only RF coil. |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - Described as "Receive-only phased array coil." | |
| Decoupling | Acceptance: Mechanisms to isolate coil elements from RF fields during transmission. |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - Stated as "Switching diode decoupling." | |
| Prevention of RF Burns | Acceptance: No transmission of RF power; decoupling isolates coil elements; coil elements and circuitry enclosed in non-conductive housing. |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - Device does not transmit RF power, uses decoupling, and has elements/circuitry enclosed in a non-conductive housing. | |
| Radio Frequency Absorption | Acceptance: No transmission of RF power. |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - Coil is receive-only and does not transmit RF power. | |
| Formation of Resonant Loop | Acceptance: Design that prevents resonant loop formation (e.g., decoupling, cable length/stiffness). |
| Performance: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)" - Decoupling isolates elements; cable length and stiffness prevent looping. |
Study Information
As this is a 510(k) for a physical medical device (an MRI coil), the "study" demonstrating its performance is primarily based on comparative analysis of its technical specifications and intended use against a legally marketed predicate device. This is a common approach for demonstrating substantial equivalence for devices that are not "diagnostic algorithms" or "AI/ML devices" in the modern sense. Therefore, many of the questions regarding clinical study design for AI are not applicable.
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm. The equivalence is based on device features and intended use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic outcome is not established for this device, which is a hardware component.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI-enabled diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and performance of the predicate devices.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for this physical device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided K032415 document serves as a 510(k) premarket notification for an MRI coil, establishing its substantial equivalence to previously cleared predicate devices based on technical characteristics, intended use, and safety features. It does not involve a clinical study for diagnostic performance in the way an AI/ML diagnostic algorithm would.
§ 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.