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510(k) Data Aggregation
(63 days)
The Sharp 9000 Phased Array Brain Coil is a receive-only RF coil, used for obtaining diagnostic images of the brain, brain vasculature and other intracranial structures as well as a secondary application of imaging small joints such as knees and elbows, in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Sharp 9000 Phased Array Brain Coil is designed for use with the 1.5T Signa Horizon MRI scanner manufactured by GE Medical Systems.
The Sharp 9000 Phased Array Brain Coil is designed to provide Magnetic Resonance Images of the brain anatomy. The Sharp 9000 Phased Array Brain Coil is designed for use with the GE Signa Horizon 1.5T scanner.
The indications for use are the same as for standard imaging:
The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Sharp 9000 Phased Array Brain Coil is a four loop receive-only coil. The coil consists of two sections: a left and right section, which are positioned on the left and right side of the patient head respectively. The left and right coil sections, each containing two loop coils and the accessory coil electronics, are enclosed in a vacuum formed housing made of polyurethane plastic, which is fire rated and has a high impact and tensile strength.
The provided text describes a Magnetic Resonance Imaging Accessory called the Sharp 9000 Phased Array Brain Coil. This device is a receive-only RF coil used for obtaining diagnostic images of the brain, brain vasculature, and other intracranial structures, as well as small joints like knees and elbows, in Magnetic Resonance Imaging Systems.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a new clinical outcome. The "performance" described is centered around demonstrating that the new device shares similar functional and safety characteristics with existing, legally marketed devices.
The table below summarizes the claimed features of the Sharp 9000 Phased Array Brain Coil and how they compare to predicate devices. The acceptance criteria implicitly seem to be "similar to predicate devices" for each feature.
| Acceptance Criteria (Implied) | Reported Device Performance (Claimed Similarity to Predicate) |
|---|---|
| Intended Use: Imaging of the brain, brain vasculature, and other intracranial structures, as well as a secondary application of imaging small joints. | Similarity: Similar to Quadrature Brain Coil Model 340GE-21C manufactured by Medical Advances, Inc. (K982918) |
| Indications for Use: Identical to routine MRI imaging. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments Inc. (K972340) |
| Coil Enclosure Material: Polyurethane Plastic and Royalite ™ R59 ABS/PVC alloy. | Similarity: Similar to Profile 7000 Quadrature Volume Neck Coil manufactured by USA Instruments, Inc. (K964531) |
| Coil Design: Four coil receive-only phased array design. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Decoupling: RF Chokes with Switching Diodes. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Prevention of RF Burns: Does not transmit RF power; decoupling isolates elements from RF fields; elements and circuitry enclosed in non-conductive housing. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Radio Frequency Absorption: Receive-only coil, does not transmit RF power; power deposition limited by SAR algorithm. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Formation of Resonant Loops: Decoupling isolates coil elements; cable length and stiffness prevent looping. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
2. Sample Size Used for the Test Set and Data Provenance
The provided submission does not describe a specific clinical study or test set with a defined sample size for performance evaluation in the way one might expect for an AI algorithm or a novel diagnostic device. Instead, the submission relies on comparison to predicate devices to demonstrate substantial equivalence. Therefore, there is no explicit "test set" or information on data provenance relating to new clinical data generation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there is no described clinical test set for independent performance evaluation, there is no information provided on experts used to establish ground truth for such a set. The regulatory review process itself involves expert review by the FDA.
4. Adjudication Method for the Test Set
As there is no described clinical test set, no adjudication method for a test set is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done or described. This device is an MRI accessory (a receive-only coil) and not an AI-powered diagnostic tool. The submission is focused on physical and functional equivalence to existing hardware.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm performance study was done or described. The device is a hardware component, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this submission is the established safety and effectiveness of the predicate devices. The Sharp 9000 Phased Array Brain Coil aims to demonstrate that its design and function are sufficiently similar to these predicate devices, implying similar safety and effectiveness. There are no mentions of expert consensus, pathology, or outcomes data being used to establish a new ground truth for this specific device.
8. The Sample Size for the Training Set
No training set is mentioned or applicable as this submission concerns a hardware medical device and not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this hardware device.
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