(78 days)
The Mark 5000 Quadrature Shoulder Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark 5000 Quadrature Coil is designed for use with the Opart 0.35 Tesla MRI scanner manufactured by Toshiba Medical Systems Inc.
The Mark 5000 Quadrature Shoulder Coil is a receive-only quadrature RF Coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Quadrature Shoulder Coil is designed for use with the Toshiba Opart 0.35Tesla MRI system manufactured by Toshiba Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The Toshiba Opart MRI system is indicated for use as an NMR device that produces images that (1) office prometers (proton density, spin lattice NWH Sighali, (2) depend upon Nim Pparamon time T2) display the soft tissue relaxation time 11, Spir-Spiritoliation interpreted by a trained physician, structure of the head and whole body. When interpreted by a trained of se structure of the nead and whole bouty. these images yield information that can be useful in the determination of a diagnosis.
The Mark 5000 Quadrature Shoulder Coil consists of two RF coil elements in a quadrature design. The coil elements and associated circuitry are enclosed to prevent any exposure to the patient or environment. The coil electronics are enclosed in both the rigid housing and the vinyl coated PVC foam. The coil is positioned on the patient's shoulder during imaging.
The provided text describes a 510(k) premarket notification for the Mark 5000 Quadrature Shoulder Coil, a Magnetic Resonance Imaging Accessory. This submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.
Therefore, many of the requested sections (including specific acceptance criteria, test results, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not detailed in this document. The submission primarily relies on direct comparison to existing devices to demonstrate safety and effectiveness.
Here's a breakdown of the information that can be extracted or deduced from the provided text, along with a clarification for unavailable information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Implied) Reported Device Performance Safety: Prevention of RF Burns - "Does not transmit RF power;"
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"decoupling isolates the coil elements from RF fields during RF transmission;"
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"coil elements and circuitry are enclosed in a non-conductive housing."
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Compared to similar features in predicate devices (K893143). |
| Radio Frequency Absorption | - "Coil is a receive only coil and does not transmit RF power;" -
"power deposition during imaging is limited by SAR algorithm."
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Compared to similar features in predicate devices (K893143). |
| Formation of Resonant Loop | - "Decoupling isolates the coil elements from RF fields during RF transmission;" -
"length of cable and stiffness does not permit looping."
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Compared to similar features in predicate devices (K893143). |
| Effectiveness/Functionality: | |
| Intended Use | "Shoulder imaging applications" - Similar to Mark 5000 Phased Array Shoulder Coil (K893143) and Quadrature Shoulder Coil by Hitachi (K992650). |
| Indications for Use | "Identical to routine MRI imaging" - Similar to Mark 5000 Phased Array Shoulder Coil (K893143). |
| Coil Design | "Receive-only Quadrature design" - Similar to Quadrature Shoulder Coil by Hitachi (K992650). |
| Decoupling | "Switching diode decoupling" - Similar to Mark 5000 Shoulder Coil (K893143). |
| Compatibility | Designed for use with the Opart 0.35 Tesla MRI scanner manufactured by Toshiba Medical Systems Inc. (Implied acceptance criterion based on the product's design and stated intended use in conjunction with this specific scanner.) - This is a functional specification rather than a performance claim to be proven by a study in this document. |Note: The "acceptance criteria" above are inferred from the safety and effectiveness comparisons made to predicate devices. The document does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics from a study.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document relies on comparison to predicate devices and general design principles rather than a clinical performance study with a test set of images or patients.
- Data Provenance: Not applicable, as no specific test set data is presented.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is described.
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Adjudication method for the test set:
- Not applicable. No test set or adjudication process is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is an MRI accessory (a coil), not an AI-based image analysis tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an MRI coil, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The submission focuses on device design, safety features, and functional equivalence to predicate devices, not on diagnostic accuracy based on ground truth data.
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The sample size for the training set:
- Not applicable. This is an MRI accessory (coil), not an AI-based system requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of the Study (or lack thereof) to Prove Device Meets Acceptance Criteria:
The provided document is a 510(k) premarket notification, which establishes substantial equivalence for a medical device. For this device (Mark 5000 Quadrature Shoulder Coil), the "study" to prove it meets acceptance criteria primarily consists of comparison to legally marketed predicate devices. The manufacturer asserts that the new device is as safe and effective as the predicates by demonstrating similarities in:
- Intended Use and Indications for Use: Stated to be identical or similar to predicate devices (K893143, K992650).
- Design Characteristics: Such as coil enclosure material, coil design (receive-only quadrature), and decoupling mechanism, which are compared to predicates (K893143, K992650).
- Safety Features: Explaining how it prevents RF burns, manages RF absorption, and avoids resonant loop formation, drawing parallels to the established safety of predicate devices (K893143).
The FDA's determination of substantial equivalence (K013854) means they agreed that the device is as safe and effective as the predicate devices, thereby permitting it to be marketed. This regulatory pathway does not typically require new clinical or performance studies demonstrating discrete acceptance criteria, but rather a robust comparison to products already proven safe and effective.
§ 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.