(45 days)
The intended use of the Noras OR head coil 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 1.5T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The OR Head Coil 1.5T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 1.5T, 63.6 MHz. Each coil is connected to the MAGNETOM system by a separate cable. Use of the OR Head Coil 1.5T requires the Siemens OR Head Holder.
This submission is for a medical device (OR Head Coil 1.5T) and not a diagnostic algorithm. Therefore, many of the requested criteria, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth definitions, are not applicable in the context of device clearance for an MRI head coil.
The regulatory approval for this device (K060758) is based on substantial equivalence to a predicate device, not on meeting specific quantifiable performance metrics for an AI algorithm.
However, I can extract the relevant information regarding the device itself and its safety and effectiveness considerations from the provided text.
Here's a breakdown of the relevant information:
Acceptance Criteria and Device Performance (in the context of a medical device submission)
| Criterion | Reported Device Performance/Compliance |
|---|---|
| Substantial Equivalence | The Noras OR Head Coil 1.5T is deemed substantially equivalent to the predicate device, "MRI Devices Corporation (now Invivo Corporation) High Resolution Head Coil - Model HRH-63-8" (K013159, cleared October 16, 2001). This is the primary "acceptance criterion" for 510(k) clearance. |
| Intended Use | The device's intended use matches the predicate device for MR examination. It is intended for MR examination of the human brain just before, during, and at the end of brain surgery in the operating room. It can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI. When used with 1.5T MAGNETOM Systems, it produces transverse, sagittal, coronal, and oblique images of head internal structures. These images, when interpreted by a trained physician, provide useful diagnostic information. |
| General Safety and Effectiveness Concerns (Standards Compliance) | The OR Head Coil 1.5T will conform to: FDA recognized NEMA Standards for the measurement of performance and safety parameters.IEC standards for safety issues with Magnetic Resonance Imaging Devices, specifically IEC 60601-2-33: 2002.NEMA tests were performed on Software platform syngo MR2004A, and the Common Risk Analysis for syngo MR2006A (same functionality) was included. The NEMA tests on the Symphony are deemed applicable to all MAGNETOM 1.5T systems. Performance is considered safe and effective when used with currently available MAGNETOM 1.5T systems. |
| Technological Characteristics | The device is an 8-channel phased array coil, divided into a bottom and top array of 4 channels each. Each channel is tuned to the Larmor frequency of the 1H spin in a 1.5T magnetic field (63.6 MHz). Each coil connects to the MAGNETOM system via a separate cable. It requires the Siemens OR Head Holder. These characteristics are considered "substantially equivalent" to those of the predicate device, despite the predicate being limited to use outside the operating room. |
Study Details (as inferable from the document, though not a typical "study" for an AI algorithm)
- Sample Size used for the test set and the data provenance: Not applicable. This is a device clearance for hardware. NEMA tests involve standardized phantoms and equipment, not patient data in the sense of a clinical trial for an algorithm. The "test set" here refers to the device itself being tested for compliance with engineering standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for device hardware testing. Ground truth (e.g., accurate measurements) for NEMA standards compliance is established by the test procedures themselves.
- Adjudication method for the test set: Not applicable. Compliance with NEMA and IEC standards is determined by achieving defined measured values.
- 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. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (head coil).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the NEMA and IEC standards, the "ground truth" is adherence to predefined technical specifications and safety limits for electromagnetic fields, image uniformity, signal-to-noise ratio, etc. These are engineering and physics-based measurements.
- The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.