(69 days)
The Mark 5000 Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International. The indications for use are the same as for standard imaging: The Picker Outlook 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 Mark 5000 Phased Array Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing. The coil is positioned on the patient's shoulder, by means of straps, during imaging.
The provided text describes the Mark 5000 Phased Array Shoulder Coil, a magnetic resonance imaging accessory. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity.
The document is a "Summary of Safety and Effectiveness" submitted to the FDA for 510(k) clearance, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence. The focus is on demonstrating that the new device is as safe and effective as existing devices, rather than establishing de novo performance criteria.
Therefore, many of the requested details cannot be extracted from this document. Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Intended Use: Shoulder imaging applications | Identical to routine MRI imaging (compared to predicate) |
| Indications for Use: Identical to routine MRI imaging | Identical to routine MRI imaging (compared to predicate) |
| Coil Enclosure Material: Acceptable for medical use | Vinyl Fabric, ABS/PVC plastic alloy, Polyurethane Plastic (similar to predicates) |
| Coil Design: Two-channel receive-only phased array coil | Two channel receive-only phased array coil (similar to predicate) |
| Decoupling: Switching diode decoupling mechanism | Switching diode decoupling (similar to predicate) |
| Prevention of RF Burns: Does not transmit RF power, decoupling isolates elements, non-conductive housing | Does not transmit RF power; decoupling isolates the coil elements from RF fields during RF transmission; coil elements and circuitry are enclosed in a non-conductive housing. |
| Radio Frequency Absorption: Receiver only, power deposition limited by SAR algorithm | Coil is a receive only coil and does not transmit RF power; power deposition during imaging is limited by SAR algorithm. |
| Formation of Resonant Loop: Decoupling isolates elements, cable length/stiffness prevents looping | Decoupling isolates the coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping. |
| Substantial Equivalence: To predicate devices (K945778, K960497, K980157, K945827, K964531) | The FDA determined the device is substantially equivalent to predicate devices. |
Explanation: The "acceptance criteria" here are largely implied by the comparison to predicate devices, focusing on design, safety features, and functional equivalence rather than specific quantitative performance metrics of image quality or diagnostic accuracy. The "reported device performance" are statements of its design and function that align with the predicates.
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a clinical study with a test set of patient data. The safety and effectiveness are established through comparison to predicate devices and engineering design rationale.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. No specific test set with ground truth established by experts is mentioned. The ultimate interpretation of images for diagnosis is stated to be by a "trained physician," but this is for clinical use, not for a performance study of the device itself.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. 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:
- Not applicable. This device is an MRI accessory (a shoulder coil), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. No ground truth data for a performance study is mentioned. The "ground truth" for this type of submission is essentially the proven safety and effectiveness of the existing predicate devices.
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The sample size for the training set:
- Not applicable / Not provided. This is not an AI device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not relevant.
Summary of what the document does provide:
- Intended Use and Indications for Use: Clearly stated, and are identical to routine MRI imaging.
- Device Description: Detailed information about the physical characteristics and components.
- Comparison to Predicate Devices: Extensive comparison of its features and safety aspects to previously cleared devices. This is the primary method of demonstrating safety and effectiveness in a 510(k) submission.
- Safety Features: Emphasizes that it is a receive-only coil, has decoupling to prevent RF burns, and incorporates a non-conductive housing.
- Regulatory Classification: Class II, procode 90 MOS.
- FDA Clearance: The device received 510(k) clearance based on substantial equivalence to predicate devices.
§ 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.