(28 days)
The intended use of the Noras OR Head Coil 3T 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 3T 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 Noras OR Head Coil 3T 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 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable.
The provided document describes a 510(k) premarket notification for a medical device, the Noras OR Head Coil 3T, which is an MRI coil. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested details, such as specific acceptance criteria, detailed device performance metrics, sample sizes for test and training sets, and information about expert-established ground truth, are not available in the provided text.
Here is an analysis based on the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and conformity to general safety and performance standards, rather than proving performance against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided as there is no mention of a clinical test set or data from human subjects for performance evaluation specific to this device. The assessment relies on conformity to NEMA and IEC standards, which are likely tested with phantoms or in controlled laboratory environments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as there is no mention of a test set with expert-established ground truth in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a test set requiring adjudication.
5. 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
This information is not applicable/provided. The device is an MRI head coil, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided. The device is an MRI head coil, not an algorithm. Performance assessment is based on its physical and electrical characteristics and ability to produce images, not on standalone algorithm performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not provided as there is no specific "ground truth" mentioned in the context of a clinical performance study for this device. The document emphasizes conformity to recognized standards (NEMA, IEC) for performance and safety parameters. These standards often rely on objective physical measurements using phantoms rather than clinical "ground truth" from patients.
8. The Sample Size for the Training Set
This information is not provided as there is no mention of a "training set" in the context of the device's development or evaluation. As an MRI coil, it does not involve machine learning algorithms that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as there is no mention of a training set.
Based on the provided document, the study demonstrating that the device meets (implicitly, rather than explicitly stated acceptance criteria) is the conformity to recognized standards and substantial equivalence to a predicate device.
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Acceptance Criteria (Implied):
- Conformity to FDA recognized NEMA Standards for the measurement of performance and safety parameters.
- Conformity to IEC standards for safety issues with Magnetic Resonance Imaging Devices, specifically IEC 60601-2-33:2002.
- Substantial equivalence to predicate devices (Noras OR Head Coil 1.5T and MRI Devices Corporation High Resolution Head Coil Model HRH-63-8) in terms of intended use, technological characteristics, and safety/effectiveness.
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Study That Proves the Device Meets the Implied Acceptance Criteria:
- "The NEMA Tests were done on software platform version VB15A." (Page 3) This statement indicates that specific tests outlined by NEMA (National Electrical Manufacturers Association) standards were performed. These tests would evaluate various performance characteristics of the MRI coil, such as signal-to-noise ratio, uniformity, spatial resolution, etc.
- Conformity Statements: The document explicitly states, "The Noras OR Head Coil 3T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002." (Page 3). This serves as the primary evidence provided for meeting safety and performance expectations through adherence to established industry standards.
- Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the Noras OR Head Coil 3T is "substantially equivalent" to predicate devices (Noras OR Head Coil 1.5T and MRI Devices Corporation High Resolution Head Coil Model HRH-63-8). This implies that its performance and safety are comparable to devices already cleared for market.
In summary, the document does not contain details of a specific clinical study with explicit acceptance criteria and performance results for the Noras OR Head Coil 3T. Instead, it relies on demonstrating compliance with recognized industry standards (NEMA, IEC) and establishing substantial equivalence to previously cleared devices to prove its safety and effectiveness.
§ 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.