Search Results

Ask a specific question about this device

Ask a specific question about this device

Imaging of:

• The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels, small parts which include: wrist, elbow, ankle, shoulder, hand, knee). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
• Fluid Visualization
• 2D/3D Imaging
• MR Angiography/MR Vascular Imaging

The Flexible Small Parts coil is comprised of a flexible coil winding, tune box, and clamp. The flexible coil winding is fabricated from a single strip of copper and encased in soft closed cell foam. The winding conforms to the irregular surface of anatomy and keeps the shape it is formed to while the foam provides consistent spacing between the windings and anatomy.

Decoupling is dual active and achieved with PIN diodes. The impedance of the coil is 50 ohms nominal and it is a solenoid type coil.

The Flexible Small Parts coil is constructed with the same materials that are currently in use for the released coil set for OPART™.

This request cannot be fulfilled. The document does not contain information about acceptance criteria and device performance for the K991740 submission. It describes a medical device accessory (Flexible Small Parts coil for OPART™ MRI system) and states its intended use, but it does not include performance metrics or a study. The document is primarily a 510(k) summary and the FDA's clearance letter, which focus on substantial equivalence to a predicate device rather than detailed performance studies against specific acceptance criteria.

Ask a specific question about this device

Imaging of: The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] Fluid Visualization 2D/3D Imaging MR Angiography/MR Vascular Imaging

The Large and Medium Flexible QD Body coils are essentially a QD (quadrature) extension and a flexible version of the standard Body Coil. The extension consists of adding a saddle trace to the existing solenoid trace. The two independent RF traces have RF magnetic fields which are orthogonal (oriented at 90 degrees with respect to each other) to create a quadrature coil. The NMR signals from the two independent loops are sent to an RF front end where they are then amplified and combined (summed) to provide a resultant signal with improved signal-to-noise ratio. With the coil's flexibility. RF connectors are added which enable the coil to open for patient loading. This enables the coil to be placed directly on the patient pallet. The standard body coil requires the patient to lay on the patient pallet then the patient with pallet is slid through the body coil. An advantage of placing the patient directly on the coil is that the pallet does not go through the coil. Hence the pallet is not filling the coil. This enables the coil to be physically smaller, for improved signal to noise, without losing space for patient loading.

The provided document is a 510(k) Premarket Notification for a Magnetic Resonance Diagnostic Device Accessory (OPART™ MRT-600 Large and Medium Flexible QD Body coils).

This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device, not necessarily on proving that the device meets specific performance acceptance criteria through a rigorous independent study with defined metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or how ground truths were established, as these are typically part of a comprehensive clinical study report, which is not included here.

Instead, the submission demonstrates "safety and effectiveness" by comparing the new device to a predicate device (Matrix 3000 Flexible Spine Coil, K964753) and stating that the modifications "do not raise new questions of safety or efficacy."

However, I can extract the safety and imaging performance parameters listed for the device, which might be considered "acceptance criteria" in a general sense for the device's operational characteristics, rather than diagnostic accuracy.

Here's a summary of what information is available in the provided text, structured to address your request as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, these are not diagnostic performance metrics, but rather operational specifications. The document implicitly states that the device meets these specifications as part of its design and intended function, making it substantially equivalent to the predicate.

Ask a specific question about this device