(460 days)
The Head Coil is indicated for use as diagnostic device extension for a Philips, Siemens or GE 3.0 T MR system to provide cross-sectional 1H and/or any X nucleus images, spectroscopic images and/or spectra in any orientation of the internal structure of the head of the patient. These images when interpreted by a trained physician yield information that may assist in diagnosis.
The Head Coil is used in Magnetic Resonance Imaging and Spectroscopy (MRI, MRS). The Head Coil has been designed to be used on Siemens, Philips or GE 3.0 T MR systems. The Head Coil is a transmit/receive coil to excite and detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23 Na) nuclei. Excitation of the nuclei is achieved by applying an RF magnetic field. The detected signal is an RF voltage being induced in the Head Coil by the nuclei observed. The Head Coil mainly offers passive antenna technology for linking the MR system to the patient (and reverse).
The provided text is a 510(k) Summary for a medical device (31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil). It describes the device, its intended use, and why it is considered substantially equivalent to a previously cleared predicate device.
However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance. The document mentions "equivalent or better SNR and Image Uniformity performance" but doesn't provide specific quantitative criteria or results in a table format.
- Sample size used for the test set and data provenance. The document states "Nonclinical tests were performed on a phantom" and "Clinical images were acquired," but does not specify the sample size for either (e.g., number of phantoms, number of clinical cases/patients). It also doesn't specify data provenance beyond "in vivo" for clinical images.
- Number of experts used to establish ground truth and qualifications. This information is absent. Ground truth is only mentioned conceptually for image interpretation by a "trained physician" for diagnosis, not for a test set validation.
- Adjudication method for the test set. Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study. Not mentioned.
- Standalone (algorithm-only) performance. This is not relevant here as the device is a hardware coil, not an AI algorithm.
- Type of ground truth used. For non-clinical tests, physical phantom measurements are the "ground truth." For clinical images, it mentions "images when interpreted by a trained physician," but this isn't a formalized ground truth establishment for a study.
- Sample size for the training set. There's no mention of a training set as this is a hardware device submission, not an AI algorithm.
- How ground truth for the training set was established. Not applicable.
The document primarily focuses on demonstrating substantial equivalence through:
- Comparison of Indications for Use and Intended Use: Stating they are the same or very similar to the predicate.
- Technological Characteristics: Highlighting similarities in coil technology and safety.
- Nonclinical Tests: Phantom studies for SNR and Image Uniformity, showing "equivalent or better" performance, and compliance with NEMA standards (NEMA MS 1-2008 and NEMA MS 3-2008). It also mentions ESD tests per IEC 60601-2-33.
- Clinical Images: Stating that "adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good."
In summary, the provided text describes a medical device (an MRI coil) submission, which relies on demonstrating substantial equivalence to a predicate device through non-clinical performance data and compliance with relevant standards. It does not present a formal clinical study with detailed acceptance criteria, ground truth establishment, or reader studies typical for AI/software-as-a-medical-device (SaMD) submissions.
§ 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.