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The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a 70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The dS Sentinelle Breast 16ch 1.5T Coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8ch coil and two dS Sentinelle Lateral 1ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16ch 1.5T Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16ch 1.5T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast 16ch 1.5T Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

The provided document is a 510(k) Pre-market Notification for the dS Sentinelle Breast 16ch 1.5T Coil, a medical device used with MRI scanners. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's diagnostic performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/CADe device are not applicable or not present in this regulatory submission.

However, I can extract and infer some information related to the device's performance assessment and acceptance as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device meets safety and effectiveness requirements as outlined in FDA guidance: Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020. This guidance would contain specific performance criteria, but the document provided does not list them explicitly or provide a detailed table comparing them to the device's reported performance. Instead, it generally states that the criteria were met.

The performance testing mentioned includes:

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

The document does not specify a distinct "test set" in the context of an AI/CADe evaluation. For the "Performance Testing – Clinical" section, it only mentions that acquired image quality was assessed. It doesn't specify the number of patients/cases used for this assessment, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically not included in a 510(k) for a basic hardware component like an MRI coil.

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

For the "Performance Testing – Clinical" section, it states: "Acquired Image quality was assessed by a U.S. Board Certified radiologist...". It indicates one expert (a U.S. Board Certified radiologist), but does not specify their years of experience or if more than one assessed the images. There is no "ground truth" to be established in the context of a diagnostic outcome for a coil itself, as the coil simply produces images. The expert's role was to confirm the diagnostic usability of the images.

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

Not applicable, as there isn't a "test set" and ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment described is a qualitative review of image quality by a single radiologist.

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 device is an MRI coil, a hardware component that produces images, not an AI or CADe device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. This device is an MRI coil and does not perform any diagnostic algorithm in a standalone manner.

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

Not applicable in the context of a diagnostic algorithm's performance. The "ground truth" for this device's performance is whether the images it produces are of sufficient quality for diagnostic use, which was determined by a radiologist's assessment. There is no disease outcome or pathology as a "ground truth" for the coil itself.

8. The sample size for the training set:

Not applicable. This device is an MRI coil, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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