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The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is intended to operate with the Signa® 1.5T Magnetic Resonance System. The coil is simply to improve the signal-to-noise performance of the MR system in specific anatomical areas.

The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is intended for general diagnostic use to present magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance of phosphorus (31P) spectra.

The coil consists of two 5 inch by 6.5 inch surface coils that are electronically summed to create a corotating "saddle-coil" pair. The two coils are contained in a flexible material, covered with fabric. This allows the flex coil to bend in one direction, making it easy to wrap around the anatomy of interest. The unit is 21" long (not including straps) by 8" wide.

The Signa® 1.5T Phosphorus (3) Transmit/Receive Flex Coil consists of two overlapped loop coils . with an octogonal shape. The two coils are contained in a flexible foam material with a cleanable coated surface.

The flexibility of the coil makes it easy to wrap the coil around the anatomy of interest.

The 31P Flex Coil performs best when closest to a circular shape, and less well when in flatter configuration.

The coils are 13cm by 16.5cm surface coils that are electronically summed to create co-rotating "saddle" coil pair. When the coil pair is aligned properly, this saddle design provides good uniformity across the senstive volume of the coil.

The 1.5T Phosphorous (31P) Transmit/Receive Flex Coil is available in configurations for fixed sites and relocatable units.

The subject magnetic resonance surface coil has the same technological characteristics as the legally marketed predicate magnetic resonance surface coils. Specifications, specifications, materials, and mode of action are equivalent.

The provided text does not contain information about acceptance criteria and a study to prove a device meets those criteria. The document is primarily a 510(k) premarket notification for a medical device: the "Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil."

This notification focuses on demonstrating substantial equivalence to previously marketed devices, rather than presenting a performance study against specific acceptance criteria. The key aspects of the document are:

• Device Identification: Naming the device and manufacturer.
• Predicate Devices: Identifying similar devices already on the market to establish substantial equivalence.
• Indications for Use: Defining how the device is intended to be used.
• Device Description: Explaining the physical characteristics and function of the coil.
• Clinical Benefits & Features: Highlighting the design and expected performance improvements (e.g., improved signal-to-noise ratio).
• FDA Clearance: The letter from the FDA stating that the device is substantially equivalent to predicate devices and can be marketed.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The document's purpose is a regulatory submission for market clearance based on substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria.

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