(31 days)
The Liberty 9000 8-ch 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 plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the Excite 1.5T system, manufactured by General Electric Healthcare.
The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner.
The indications for use are the same as for standard imaging:
The Signa Excite 1.5T 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 reluxation 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 9000 8-ch Breast Coil with Disposable Biopsy Plate is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four 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 9000 8-ch 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 is a 510(k) premarket notification for a medical device, specifically a "Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate" for Magnetic Resonance Imaging. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data to prove performance against specific acceptance criteria. Therefore, the document does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or ground truth establishment in the way typically seen for new diagnostic algorithms or devices requiring extensive clinical validation.
The document primarily focuses on:
- Device Description and Intended Use: Detailing the physical characteristics and purpose of the breast coil.
- Comparison to Predicate Devices: Explicitly stating that the device is "Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate" (K001582) and other cleared devices, emphasizing similarities in features, intended use, indications for use, and safety aspects.
- Safety Features: Highlighting design aspects that mitigate risks like RF burns and resonant loops (e.g., receive-only coil, decoupling, non-conductive housing).
Given this context, I will address the requested points by explaining why the information is not present in the provided text for a 510(k) submission of this nature.
1. A table of acceptance criteria and the reported device performance
Information Not Available: This document does not present a table of acceptance criteria or reported device performance metrics in the way one would expect for a novel diagnostic algorithm or a device requiring new performance claims. As a 510(k) submission for a medical device accessory (an MRI coil), the focus is on demonstrating that the device is substantially equivalent to a legally marketed predicate device, particularly in terms of safety and functionality. Performance is implicitly demonstrated by showing it functions similarly to the predicate for its intended use (obtaining MR images of the breast).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information Not Available: No specific test set, patient data, or clinical study data (prospective or retrospective) from which performance metrics would be derived is mentioned in this 510(k) summary. The submission relies on a comparison to predicate devices, engineering design specifications, and safety assessments rather than new clinical trials with patient cohorts.
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)
Information Not Available: Since no specific test set or clinical study is described, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Available: No test set or clinical study is described, so no adjudication method is mentioned.
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
Information Not Available: This document describes an MRI breast coil, which is a hardware accessory, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Not Available: This device is an MRI coil, a hardware component, not a standalone algorithm. Thus, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information Not Available: As no clinical studies or test sets are described, there is no mention of the type of ground truth used.
8. The sample size for the training set
Information Not Available: This device is an MRI coil, not an AI-driven algorithm, so the concept of a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
Information Not Available: As the concept of a "training set" does not apply to this device, the establishment of ground truth for such a set is not mentioned.
§ 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.