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The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are single tuned surface type transmit and receive coils for usage in magnetic resonance systems, the operating frequency and interface being adapted for usage on Philips 3.0 T MR Systems. The coils are for transmit and receive (T/R) and provide the required magnetic RF field for excitation of the spins and receive the MR signal of 31P, 23Na or 13C spins. This is used for axial, sagittal, coronal and oblique imaging, spectroscopic imaging and/or spectroscopy, which display the internal structure and/or function of the human anatomy, e.g. of the calf, liver or heart.The coils are optimized for local examinations of human subjects. The housing is flexible for better adaption to the anatomical region of interest. The coils consist of a single loop (linear) with a diameter of 14 cm, RF routing (T/R switch), a low noise preamplifier and a connector to the Philips 3.0 T MR Systems. The coils are fixed tuned and matched to the typical load of human tissue at the Larmor frequency of 31P (51.7 MHz), 23Na (33.8 MHz) or 13C (32.1 MHz) at 3.0 T. There is no detuning or switching mechanism in the loops. The loops are tuned permanently to the working frequencies of 31P, 23Na or 13C while being decoupled from the 1H body coil at the 1H frequency.

The provided text is a 510(k) summary for MRI coils. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specified performance criteria through a human-in-the-loop or standalone AI study.

The document discusses:

• The indications for use of the P-140-Flex Coil, Na-140-Flex Coil, and C-140-Flex Coil as diagnostic device extensions for Philips 3.0T MR Systems to produce cross-sectional spectroscopy images and/or spectra.
• The device description, noting they are single-tuned surface transmit and receive coils.
• Comparisons to a predicate device (Philips P-140 Coil), highlighting improvements like flexible housing for better patient comfort without detrimental effects on safety, reliability, or other performance topics.
• Conformity to IEC standards (60601-1 and 60601-2-33) to assure safe and effective performance.
• A brief statement that "Testing was performed to support this claim of substantial equivalence and to show that the modifications do not raise any new questions pertaining to safety and effectiveness."

Based on the provided text, I cannot answer the specific questions about acceptance criteria for device performance, the study design, sample sizes for test/training sets, ground truth establishment, or human reader performance with/without AI assistance, as this information is not present. The document focuses on demonstrating substantial equivalence to a predicate device based on similar technology, intended use, and compliance with general safety standards for MR coils, rather than a clinical performance study with defined acceptance criteria for image interpretation or diagnostic accuracy.

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