(98 days)
The Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images can be interpreted by a trained physician. When used with a sterile fenestrated plate, this device permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
The Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems is a receive-only MRI imaging coil and interventional system for the breast anatomy. The system consists of a table base and/or a tabletop supports the patient, the imaging coils and means for modest compression/immobilization of the breast, as well as a means of enabling interventional device guidance. The table base (optional) is used to support and transport the tabletop. The tabletop, like other breast coils provides an aperture to admit the breasts. A corresponding aperture in the table base maximizes physician access to the breast(s) when the tabletop is at the home position. This table aperture is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach. The tabletop's compression system facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). Compression plates provided with the system are held in compression frames which may be positioned in the left-right and anterior-posterior directions and fixed in place to gently immobilize one or both breasts for interventional procedures. When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plate cleared under FDA 510(k) number: K060873. The fenestrated plate has apertures that permit the physician to access the breast for intervention, while minimizing tissue motion. When performing biopsy and/or imaging of a single breast, the system may be used with two compression plates immobilizing that breast. The contralateral breast support prevents the contralateral breast from interfering with medial-approach interventions. When imaging both breasts, a medial coil element is used between the breasts in conjunction with two lateral coils. The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The function of the tabletop is substantially equivalent to predicate devices used for breast MRI maging and intervention, including our legally marketed device 510(K) Number: K060873. The Vanguard phased array coil set consists of 8 or 16 RF coil elements in a phased array design. The 16 channel coil array may be interchanged with a 10 or 2-channel coil array. The coil elements and electronics are enclosed in a rigid housing that is resistant to fluid ingress and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.
This document describes the Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MR Systems, designed to provide magnetic resonance images of breast anatomy and facilitate biopsy and localization procedures.
Important Note: The provided document is a 510(k) Premarket Notification summary, which focuses on device description, intended use, and substantial equivalence to a predicate device. It does not contain a detailed study report with specific acceptance criteria, device performance results, or extensive statistical analysis typically found in full clinical or performance studies. The information below is extracted based on what is available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission and not a detailed performance study, explicit, quantitative acceptance criteria and corresponding reported device performance values like sensitivity, specificity, accuracy, or reader agreement are not present in the provided text for the new device.
The submission focuses on the device's functional equivalence and improvements over an existing predicate device. The "performance" described is in terms of the intended benefits for image quality and acquisition time, which are qualitative improvements rather than specific, measurable performance metrics against a defined ground truth.
| Acceptance Criteria (Implied/Stated in 510k) | Reported Device Performance (Implied/Stated in 510k) |
|---|---|
| Ability to provide magnetic resonance images of breast anatomy. | The device is designed to provide magnetic resonance images of breast anatomy. |
| Compatibility with GE 1.5T/3T MRI Systems. | New models listed are compatible with specific GE Discovery and Signa MR systems. |
| Facilitates biopsy and localization procedures when used with a sterile fenestrated plate. | The device permits access to the breast anatomy for biopsy and localization. |
| Improved Signal-to-Noise Ratio (SNR) compared to a standard body coil. | "An increase in the Signal-to-Noise Ratio (improving image detail)." |
| Decreased imaging acquisition time due to enhanced parallel imaging capability. | "A decrease in imaging acquisition time resulting from enhanced parallel imaging capability." |
| Substantial equivalence to predicate devices (K060873) for breast MRI imaging and intervention. | Based on the 510(k) clearance, the FDA determined the device is "substantially equivalent." |
| Safety and effectiveness. | The 510(k) summary is for "Safety and Effectiveness." (Implicitly accepted by FDA clearance). |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not contain information about a dedicated "test set" with a specific sample size, data provenance (country of origin, retrospective/prospective), or a formal study design for evaluating the new device's performance against ground truth.
510(k) submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with test sets, especially for accessories like MRI coils. The improvements mentioned (SNR, acquisition time) are inherent to the coil design (e.g., more channels, phased array design) and are generally accepted principles in MRI technology, often supported by engineering tests and phantom studies, rather than large-scale patient test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since a formal "test set" or clinical study with ground truth establishment is not detailed in this 510(k) summary, this information is not provided.
4. Adjudication Method for the Test Set
As no specific test set or clinical study requiring adjudication is detailed in this 510(k) summary, this information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
An MRMC comparative effectiveness study was not mentioned or described in the provided 510(k) summary. This device is an MRI coil system, not an AI or CAD (Computer-Aided Detection) software, so an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a hardware component (MRI coil system), not a standalone algorithm or software.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Since a formal clinical study with ground truth is not detailed, the type of ground truth used is not specified in the provided 510(k) summary. The "ground truth" for demonstrating substantial equivalence primarily involves showing the new device functions similarly and safely to the predicate device, with described improvements being technical characteristics rather than diagnostic performance metrics against a clinical gold standard.
8. The Sample Size for the Training Set
The provided 510(k) summary does not describe a "training set" in the context of an algorithm or AI development. This device is a hardware component; therefore, the concept of a training set as used in AI is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no described training set, the method for establishing its ground truth is not applicable and therefore not provided in the document.
Summary of Study Context (Based on 510(k) Submission):
The document is a 510(k) Premarket Notification, which primarily aims to demonstrate substantial equivalence to a previously cleared predicate device (K060873), rather than presenting a de novo clinical study with detailed performance metrics. The improvements highlighted (increased SNR, decreased acquisition time) are technical advancements in the coil design (more channels, phased array) that are inherent to the physics of MRI and are generally accepted to enhance image quality and efficiency. The FDA's clearance indicates that the device met the regulatory requirements for safety and effectiveness through demonstration of substantial equivalence.
§ 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.