(78 days)
The Leo 7000 Quadrature Knee Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the knee anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Knee Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Leo 7000 Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee anatomy. The Leo 7000 Quadrature Knee Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
The indications for use are the same as for standard imaging:
The GE Signa 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 Leo 7000 Quadrature Knee Coil is a bird-cage resonator. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane material, which is fire rated and has high impact and tensile strength. The Leo 7000 Quadrature Knee Coil is a quadrature volume coil with a split-top design.
The provided text describes a 510(k) submission for a Magnetic Resonance Imaging Accessory, specifically the Leo 7000 Quadrature Knee Coil. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal clinical study with ground truth. Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate device comparison) | Reported Device Performance (for Leo 7000 Quadrature Knee Coil) |
|---|---|---|
| Intended Use | Knee Imaging Applications (Predicate Device: MR Quadrature Knee Coils, Hitachi Medical Systems (K914263)) | Knee Imaging Applications |
| Indications for Use | Identical to routine MRI imaging (Predicate Device: Lower Extremity Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)) | Identical to routine MRI imaging (Knee anatomy) |
| Coil Body Former Material | (Predicate Device: Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)) | Flame retardant Polyurethane |
| Coil Design | (Predicate Device: Quadrature head coil and Quadrature MRA coil, HI-STAR MRI system, Health Images, Inc. (K944724)) | Quadrature receive-only, bird-cage resonator |
| Decoupling | (Predicate Device: Lower Extremity Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)) | RF Chokes with Switching Diodes |
| Prevention of RF Burns | 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 (Predicate Device: Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)) | 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 | Coil is a receive only coil and does not transmit RF power (Predicate Device: Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)) | Coil is a receive only coil and does not transmit RF power |
| Formation of Resonant Loops | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping. (Predicate Device: Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)) | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping. |
Study Information (Based on 510(k) Submission):
The document provided is a 510(k) Premarket Notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically relies on comparing technical characteristics and performance to existing, approved devices, rather than conducting new, large-scale clinical trials with acceptance criteria in the traditional sense of a clinical study assessing diagnostic performance.
The "study" in this context is a comparison to predicate devices to demonstrate substantial equivalence, as detailed in section 9, "Safety and Effectiveness," which primarily focuses on technical and functional comparisons.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a specific "test set" or clinical data. The submission relies on demonstrating substantial equivalence to predicate devices based on design and technical specifications. There are no mentions of patient data, data provenance, or study design for performance evaluation.
3. 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. No "test set" requiring expert ground truth establishment is described in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "test set" requiring adjudication is described.
5. 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 is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a passive medical device (MRI coil), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for device performance as typically understood in diagnostic studies. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which it is compared.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set."
§ 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.