(11 days)
The TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is compatible with the 3T Magnetom Trio MR scanner manufactured by Siemens Medical Systems.
The TEM 3000 Head Coil is a 15-element quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent any exposure to patient or environment. The coil housing employs a large open viewing window on the top. The coil design facilitates the scanning of patients with different window on the top: "Ifizes patient comfort and ease of use. Included with the coil housing is a Head Support/Coil Base. It allows the coil to be slid back for better patient access.
The provided text describes a 510(k) premarket notification for the TEM 3000 Head Coil and does not contain information about acceptance criteria or a study proving the device meets them. The document is from 2004 and is a regulatory submission for a medical device rather than a scientific study report.
Therefore, most of the requested information cannot be extracted from this document, specifically:
- 1. A table of acceptance criteria and the reported device performance: Not available. The document is a regulatory filing, not a performance study report.
- 2. Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of a performance study is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method: Not available.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated.
- 6. If a standalone was done: Not indicated.
- 7. The type of ground truth used: Not available.
- 8. The sample size for the training set: Not available.
- 9. How the ground truth for the training set was established: Not available.
What the document does indicate:
The document describes the TEM 3000 Head Coil as a 15-element quadrature transmit/receive coil intended for 'H high-resolution whole-head adult and pediatric imaging, including functional MRI, spectroscopy, and angiography. It is compatible with the Siemens 3T Magnetom Trio MR System.
The submission focuses on establishing substantial equivalence to a predicate device, the Magnetom Trio Head Coil (K021330), based on similar construction and operation, despite using TEM technology instead of "Birdcage" technology. Substantial equivalence in this context means the new device is as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical performance study with acceptance criteria as typically understood in a scientific evaluation.
§ 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.