(138 days)
The Liberty 5000 Breast Coil with Disposable Biopsy Plate is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 5000 Breast Coil with Disposable Biopsy Plate. The indications for use are the same as for standard MR Imaging. The Liberty 5000 Breast Coil with Disposable Biopsy Plate is designed for use with the 0.7T Altaire MRI scanner manufactured by Hitachi Medical Systems.
The Liberty 5000 Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Liberty 5000 Breast Coil with Disposable Biopsy Plate is designed for use with the Hitachi Altaire 0.7T scanner.
The indications for use are the same as for standard imaging:
The Altaire 0.7T 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 Liberty 5000 Breast Coil with Disposable Biopsy Plate is a phased array, receive-only MRI coil. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Liberty 5000 Breast coil with Disposable Biopsy Plate is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
The provided text describes a 510(k) premarket notification for a medical device, the Liberty 5000 Breast Coil with Disposable Biopsy Plate. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new diagnostic algorithm.
Here's an analysis based on the information provided, addressing your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not contain a table of explicit acceptance criteria or quantitative performance metrics in the way a diagnostic algorithm's accuracy (e.g., sensitivity, specificity, AUC) would be evaluated. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The "reported device performance" is descriptive, comparing the features and intended use of the new device to existing cleared devices.
| Feature/Criterion (Implied Acceptance) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Breast Imaging for diagnostic purposes with biopsy access. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582), OBC-300 Breast Array Coil (K993776), and MR Guided Procedures (MRGP) Basic Package Biopsy Plate (K983342). |
| Indications for Use: Identical to routine MRI imaging (providing images corresponding to proton distribution, NMR parameters, and soft tissue structure, useful for diagnosis when interpreted by a trained physician). | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). The indications for use are the same as for the Hitachi Altaire 0.7T system, which is indicated for use as an NMR device that produces images of soft tissue structure of the head and whole body, useful for diagnosis when interpreted by a trained physician. |
| Coil Enclosure Material: Polyurethane Plastic, ABS Plastic, Polycarbonate, and Delrin. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Coil Design: Receive-only phased array design. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Decoupling: RF Chokes with Switching Diodes. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Prevention of RF Burns: Does not transmit RF power; decoupling isolates elements; elements/circuitry in non-conductive housing. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Radio Frequency Absorption: Receive-only coil; power deposition limited by SAR algorithm. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Formation of Resonant Loops: Decoupling isolates elements; cable length/stiffness prevents looping. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
The core "study" here is the comparison of the device's features and performance characteristics to those of predicate devices that have already received 510(k) clearance. The FDA's determination of "substantial equivalence" is the "proof" that the device meets the implied "acceptance criteria" of being as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance for a performance study in the context of an AI/algorithm-driven device. The safety and effectiveness are established through the comparison of the device's physical and functional attributes to predicate devices, and an analysis of potential risks (like RF burns, resonant loops, etc.) based on its design. This is a hardware device, not an algorithm, so data provenance, retrospective/prospective studies, and test sets with patient data are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, this submission is for a physical medical device (an MRI coil), not a diagnostic algorithm that requires expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done, and it would not be applicable for this type of device (an MRI coil). MRMC studies are typically performed to evaluate the diagnostic accuracy of image interpretation, often comparing human readers with and without AI assistance. This device is an accessory for image acquisition, not an image interpretation tool.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an algorithm's performance was not done. The concept of "standalone performance" refers to the accuracy of an AI algorithm operating without human intervention for diagnostic tasks, which is not relevant to an MRI coil.
7. The Type of Ground Truth Used
Not applicable. Ground truth (e.g., pathology, outcomes data) is used to validate diagnostic algorithms or tests against a definitive standard. This document focuses on the physical and functional equivalence of an MRI accessory.
8. The Sample Size for the Training Set
Not applicable. This device is an MRI coil, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
§ 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.