(88 days)
The Neonate (Head, Body) Coil is a quadrature transmit/receive coil used for obtaining diagnostic images and spectra of the (pre- and term) infant head in 1,5 and 3,0 Tesla General Electric, Siemens Medical Solutions and Philips Medical Systems' Magnetic Resonance Imaging (MRI) scanners and magnetic resonance compatible incubator systems. Indications for use are same as that for standard MR imaging.
The Neonate Coils when used in conjunction with the MRI systems or Neonate coils when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
The Neonate (Head, Body) Coil is a 12 element quadrature, transmit/receive coil. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The coil design facilitates scanning of pre-term and term newborn babies with different head and body sizes and maximizes comfort and ease of use.
Here's a breakdown of the acceptance criteria and study information for the Advanced Imaging Research Neonate Coils based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not list specific numerical acceptance criteria or performance metrics (e.g., signal-to-noise ratio, image resolution, specific absorption rate limits with associated values). Instead, it describes general safety and functionality aspects that the device meets.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Safety - Mechanical/Exposure | Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. |
| Safety - RF Burns | Transmit and receive channels are isolated with pin-diodes; coil elements and associated circuitry are enclosed in plastic housing. |
| Safety - RF Absorption | Radio-frequency power deposition is limited in the coil specific file embedded in the MRI and by SAR algorithm of the MRI scanner. |
| Safety - Resonance Loops | Active diodes and RF fuses isolate the coil elements from whole body RF coil transmit; length and routing of output cable does not permit looping. |
| Functionality - Design | Coil design facilitates scanning of pre-term and term newborn babies with different head and body sizes and maximizes comfort and ease of use. |
| Functionality - Compatibility | Works with 1.5T and 3.0T GE, Siemens, and Philips MRI scanners and MRI-compatible incubator systems. |
| Functionality - Imaging Modalities | Proton 1H 1D, 2D, 3D T1, T2 weighting, proton density, chemical shift, diffusion weighted imaging, angiography, functional MRI, chemical shift imaging, spectroscopy. |
| Equivalence to Predicate | Substantially equivalent to Advanced Imaging Research's Neonate (Head, Body) Coils (K023929). |
| New Hazards | Testing and usage of the 3.0T Neonate Coils does not result in any new potential hazards. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative sample size (e.g., number of subjects, number of images) for the test set. It states "Testing was performed to demonstrate that the 3.0 T Neonate Head Coils meet the predetermined acceptance criteria." Test-set subjects would likely be phantoms or a limited number of human subjects for safety testing, but specific numbers are not provided.
- Data Provenance: Not specified. This type of device (MR coil) typically undergoes technical performance and safety testing, which often involves engineering tests and phantom studies rather than extensive clinical data. The document does not indicate if any human subject data, retrospective or prospective, was used for performance evaluation beyond safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For this product which is a coil, the "ground truth" during testing would likely be based on established engineering standards for MRI coil performance, safety limits, and image quality measurements, rather than clinical interpretation requiring expert radiologists to establish a diagnostic ground truth. The interpretation of images for diagnosis is stated to be by a "trained physician," but this is for clinical use, not for establishing ground truth during the device's technical acceptance testing.
4. Adjudication Method for the Test Set
Not applicable/Not specified. Given the nature of the device (MRI coil) and the type of testing implied (technical performance and safety), an "adjudication method" as typically used in clinical studies for diagnostic accuracy (e.g., 2+1 reads) is not relevant or described. Acceptance would be based on meeting engineering specifications and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not performed or described. This type of study assesses reader performance with and without an AI algorithm, which is not applicable to an MRI coil itself. The device is a hardware component.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was it done? No, a standalone algorithm performance study was not done. The device is an MRI coil, a hardware component, not a software algorithm.
7. Type of Ground Truth Used
The ground truth for the "testing" mentioned in the document would be based on engineering specifications, physical measurements, and safety standards (e.g., SAR limits, electrical isolation, signal-to-noise ratio measurements using phantoms, geometric distortion assessment). It is not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic medical device.
8. Sample Size for the Training Set
Not applicable. The device is an MRI coil (hardware). There is no "training set" in the context of machine learning or AI algorithms for this product.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this hardware 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.