(73 days)
The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2) and (3) display the internal structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The SSA coil is indicated for use in the following anatomic regions and with the designated nuclei:
Thoracic and Lumbar or spine and sternum Anatomic Regions:
Nuclei Excited: Hydrogen
The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential.
This 510(k) summary describes a new MRI coil, the Synergy Spine Array (SSA) coil, for the Panorama 0.6T MRI system. The primary goal of the submission is to demonstrate that the SSA coil is substantially equivalent to a predicate device, the Integrated Spine Array (ISA) coil for the Philips Infinion 1.5T system, in terms of safety and effectiveness.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets. Instead, the document relies on demonstrating "substantial equivalence" to the predicate device. The performance is assessed by confirming that key safety and performance parameters are "unaffected" by the new coil and that technological differences "do not raise new questions pertaining to safety and effectiveness."
| Parameter Category | Acceptance Criteria (Implied) | Reported Device Performance (SSA Coil) |
|---|---|---|
| Safety Parameters | Substantially equivalent to predicate, unaffected by SSA coil | Unaffected by the SSA coil |
| Static Field | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| dB/dt | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| SAR | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| Acoustic Noise | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| Performance Parameters | Substantially equivalent to predicate, unaffected by SSA coil | Unaffected by the SSA coil |
| SNR | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Image Uniformity | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Geometric Distortion | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Slice Thickness & Spacing | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Spatial Resolution | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Phantom and clinical studies were performed to support the claim of substantial equivalence," but it does not specify the sample size for either the phantom or clinical studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Intended Use" section mentions "When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis," which implies a physician reviews the images, but this is a general statement about clinical use, not a specific detail about the validation study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on equivalence of the device itself rather than human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an accessory device (MRI coil), not an algorithm or AI. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply to this submission. The evaluation is of the hardware's imaging capabilities.
7. The Type of Ground Truth Used
For the phantom studies, the ground truth would be precise, known physical properties and measurements within the phantom.
For the clinical studies, the document does not explicitly state the type of ground truth used. It's broadly implied that the images produced by the SSA coil are evaluated to determine if they provide "information that can be useful in the determination of a diagnosis." This suggests a comparison against a clinical "gold standard" or expert interpretation from other imaging modalities, but this is not detailed. Expert consensus or clinical diagnosis would be the most likely type of ground truth for human-interpreted clinical images, but it's not explicitly stated.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is expected as the submission is for an MRI coil, which is a hardware device, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As this is a hardware device and not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it does not apply.
§ 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.