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The Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array 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 the disposable sterile plate the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array 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 with 8 Channel Coil Array is an MRI imaging coil and interventional system for breast. The system consists of a table base and a table top. The 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 is used to support and transport the tabletop. The table base is substantially equivalent to the table provided by General Electric with their GE Signa ® MRI machines.

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 is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach.

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 plates. The fenestrated plate has apertures which permit the physician to access the breast for intervention. No biopsy needles are included with or packaged with the system.

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 imaging and intervention.

The Vanguard phased array coil set consists of 8 RF coil elements in a phased array design. The 8 coil array may be interchanged with a four coil array. The coil elements and associated circuitry are enclosed to prevent exposure to the patient or the environment. The coil electronics are enclosed in a rigid housing that is resistant to fluids 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 system is for use with GE Signa ® (3X-LX, Echo Speed, TwinSpeed) 1.5T Scanners. This system is compatible with GE Signa ® Excite platforms.

The presented document is a 510(k) summary for the "Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array for GE Signa™ systems." It details the device's characteristics and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than fulfilling specific acceptance criteria in the context of a typical AI/ML device study.

Therefore, many of the requested fields related to acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC comparative effectiveness studies are not applicable to this type of submission for an MRI coil accessory. The submission focuses on technical performance and safety comparisons to predicate devices.

Here's a breakdown of the information that can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document mentions "volunteers" for additional comparison in Attachment 9 and imaging phantoms for the primary performance tests. However, it does not specify the sample size for either the phantom tests or the volunteer study.

• Data Provenance: Not explicitly stated, but given the company location (Toronto, Ontario, Canada) and the submission to the FDA, the testing was likely conducted in Canada or the USA. The data is prospective as it describes performance testing conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this submission. The device is an MRI coil accessory, and the "ground truth" for its performance is assessed through technical measurements like Signal-to-Noise Ratio (SNR) and image uniformity using phantoms, rather than expert interpretation of complex clinical cases that would require a ground truth established by experts. The indications for use state "These images can be interpreted by a trained physician," but this pertains to the use of the device in clinical practice, not to the testing of the device itself for FDA clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there were no subjective interpretations requiring adjudication. Performance was measured using objective technical metrics on phantoms.

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

This is not applicable. This submission is for an MRI coil, not an AI/ML diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to objective physical measurements using imaging phantoms according to NEMA standards. For the volunteer study, the "ground truth" would be the direct physical properties of the volunteers being imaged, again assessed through objective imaging metrics. There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the device's performance.

8. The sample size for the training set

This is not applicable. The device is hardware (an MRI coil and table), not a software algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this type of device.

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