(76 days)
The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.
The Flexible Spine 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 wrapped around the patient and the ends are connected and locked. The coil has a fixed circumference.
The provided document is a 510(k) Premarket Notification Summary for a Magnetic Resonance Imaging Accessory, specifically the "Matrix 3000 Flexible Spine Coil." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets novel acceptance criteria through a clinical study. Therefore, the information requested about acceptance criteria and a study proving those criteria are met is largely not applicable in the context of this specific document.
This document describes the device, its intended use, and then compares its features, safety, and effectiveness to legally marketed predicate devices. The "study" here is essentially the comparative analysis presented in Section 9, demonstrating that the Matrix 3000 Flexible Spine Coil is as safe and effective as its predicate devices, or at least does not raise new questions of safety and effectiveness.
Here's a breakdown based on the provided text, highlighting what's present and what's absent due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there isn't a table of explicitly defined quantitative "acceptance criteria" for performance that a new clinical study would aim to meet. Instead, the "performance" is demonstrated by showing that the new device's characteristics are similar to or better than the predicate devices, particularly in terms of safety.
The table in Section 9, titled "Safety and Effectiveness," is the closest equivalent, though it compares characteristics rather than presenting criteria and measured performance.
| Parameter | Acceptance Criteria (Implied by Predicate) | Matrix 3000 Flexible Spine Coil Performance (Reported Capability) |
|---|---|---|
| Intended Use | Safe and effective for Thoracic and Lumbar Spine Imaging Applications (as demonstrated by predicate devices K960497) | Thoracic and Lumbar Spine Imaging Applications |
| Indications for Use | Safe and effective for same indications as routine MRI imaging (as demonstrated by predicate devices K960497 and K943440) | Identical to routine MRI imaging |
| Coil Enclosure Material | Suitable material for MRI coil enclosure (as demonstrated by predicate K960497 using flexible material) | Vinyl Fabric |
| Coil Design | Two-channel receive-only phased array coil design (as demonstrated by predicate K960497) | Two channel receive-only phased array coil |
| Decoupling | Effective decoupling mechanism (as demonstrated by predicate K960497 and K943440 using switching diode decoupling) | Switching Diode decoupling |
| Prevention of RF Burns | Mechanisms in place to prevent RF burns, including no transmission of RF power, decoupling of elements during transmission, and non-conductive housing (as demonstrated by predicates K943440, K960497, K945827) | Does not transmit RF PowerDecoupling isolates the coil elements from RF fields during RF transmissionCoil elements and circuitry are enclosed in a non-conductive housing. |
| Radio Frequency Absorption | Control of RF absorption/power deposition within safety limits, especially as a receive-only coil (as demonstrated by predicate K943440 and the Outlook system's SAR algorithm K945827) | 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 | Design features to prevent resonant loop formation, such as decoupling of elements during RF transmission and physical constraints on cable/stiffness (as demonstrated by predicates K943440 and K960497) | Decoupling isolates the coil elements from RF fields during RF transmissionLength of cable and stiffness does not permit looping |
Regarding a "study" that proves the device meets acceptance criteria:
The document does not describe a specific clinical study or performance trial of the Matrix 3000 Flexible Spine Coil against quantitative acceptance criteria for image quality or diagnostic accuracy. Instead, it relies on substantial equivalence to existing, legally marketed devices.
The "study" in this context is the comparison and argumentation for equivalency presented in Section 9 based on the design, function, and safety features shared with or made analogous to the predicate devices. This is a common pathway for Class II medical devices that do not introduce new technology or raise new safety/effectiveness concerns.
Specific Questions:
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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 applicable / Not disclosed. This document does not describe a test set or data from a clinical performance study. The evaluation is based on design comparison and known characteristics of MRI coils and the predicate devices.
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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 / Not disclosed. No "ground truth" establishment for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None. No adjudication method for a test set 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. This document is for an MRI coil, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is for a hardware device (an MRI coil), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not described. No ground truth for a clinical dataset is mentioned. The "ground truth" for the submission is the regulatory acceptance of the predicate devices.
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The sample size for the training set:
- Not applicable / Not disclosed. There's no mention of a training set as this is not an AI/algorithm submission.
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How the ground truth for the training set was established:
- Not applicable / Not described. As above, no training set or ground truth for one is discussed.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for an MRI coil. It compares the safety and efficacy characteristics of the new device to already-approved predicate devices. It does not contain information about a clinical performance study with specific acceptance criteria, test sets, or ground truth establishment that would typically be found in an efficacy study for a novel diagnostic device or algorithm.
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SUMMARY OF SAFETY AND EFFECTIVENESS
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SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory | |
|---|---|---|
| 2. Proprietary Name : | Matrix 3000 Flexible Spine Coil | |
| 3. Classification : | Class II | |
| 4. Establishment Registration #: | 1529041 | |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive,Highland Heights, Ohio 44143, USATelephone: 216-442-5920; Fax: 216-442-5919. | |
| 6. Performance Standard: | No applicable performance standards have been issuedunder Section 514 of the Food, Drug and Cosmetic Act. | |
| 7. Intended Use: | The Flexible Spine Coil is a receive-only phased array RFcoil, used for obtaining diagnostic images of the thoracicand lumbar spine in Magnetic Resonance Imagingsystems. The indications for use are the same as forstandard MR Imaging. The Matrix 3000 Flexible SpineCoil is designed for use with the Outlook (0.23Tesla)MRI scanner manufactured by Picker International Inc. | |
| 8. Device Description : | The Flexible Spine Coil consists of two volume RF coilelements in a quadrature design. The elements andassociated circuitry are enclosed in a flexible vinylenclosure housing. The coil is wrapped around the patientand the ends are connected and locked. The coil has afixed circumference. |
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9. Safety and Effectiveness
| Parameter | Matrix 3000 Flexible SpineCoil | Predicate |
|---|---|---|
| Intended Use | Thoracic and Lumbar SpineImaging Applications | Flexible Phased Array Spine CoilPicker International(K960497) |
| Indications for Use | Identical to routine MRIimaging | Flexible Phased Array Spine CoilPicker International(K960497)Profile 7000 C-Spine CoilsUS ASIA Instruments, Inc.(K943440) |
| Coil Enclosure Material | Vinyl Fabric | Flexible Phased Array Spine CoilPicker International(K960497) |
| Coil Design | Two channel receive-only phasedarray coil | Flexible Phased Array Spine CoilPicker International(K960497) |
| Decoupling | Switching Diode decoupling | Flexible Phased Array Spine CoilPicker International(K960497)Profile 7000 C-Spine Coils(K943440), US ASIAInstruments, Inc. |
| Prevention of RF Burns | Does not transmit RF PowerDecoupling isolates the coilelements from RF fields duringRF transmissionCoil elements and circuitryare enclosed in a non-conductivehousing. | Profile 7000 C-Spine Coils(K943440), US ASIAInstruments, Inc.Flexible Phased Array Spine CoilPicker International(K960497)Same as other Outlook CoilsPicker International(K945827) |
| Radio Frequency Absorption | Coil is a receive only coil anddoes not transmit RF power.Power deposition during imagingis limited by SAR algorithm | Profile 7000 C-Spine Coils(K943440), US ASIAInstruments, Inc.Algorithm used on Outlooksystem (K945827) |
| Formation of Resonant Loop | Decoupling isolates the coilelements from RF fields duringRF transmissionLength of cable and stiffnessdoes not permit looping | Profile 7000 C-Spine Coils(K943440), US ASIAInstruments, Inc.Flexible Phased Array Spine CoilPicker International(K960497) |
§ 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.