(255 days)
The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T 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 16 Ch 3.0T MR Coils is a receive only coil to be used on a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designed to correspond with the scanner strength.
The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels):
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16Ch for diagnostic imaging: performed in 16Ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil.
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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).
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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 3T Coil is tuned to receive RF frequency corresponding to the proton precession in a 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.
The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T 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 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.
Based on the provided text, the device in question is the dS Sentinelle Breast 16ch 3.0T Coil, which is a receive-only MR coil. The acceptance criteria and the study proving the device meets them are described in the "Summary of Non-Clinical and Clinical Performance Data" section.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document references "FDA guidance Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" for the acceptance criteria. While the specific numerical thresholds for these criteria are not explicitly detailed in the provided text, the document states that these requirements were met. It lists the types of performance tests conducted.
| Acceptance Criteria (Criteria from FDA Guidance: Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway) | Reported Device Performance |
|---|---|
| Non-Clinical Performance Criteria: | |
| Basic Safety (IEC 60601-1) | Met |
| Usability (IEC 60601-1-6) | Met |
| EMC Immunity, electrostatic discharge (IEC 60601-1-2) | Met |
| Basic Safety and essential performance of MR equipment (IEC 60601-2-33) | Met |
| Image uniformity and signal-to-noise ratio (NEMA-MS-1,3,6,9) | Met |
| Determination of essential image quality parameters (IEC62464-1) | Met |
| Biological safety (ISO 10993-1) | Met |
| Cleaning and disinfection validations (ISO 17664) | Met |
| Clinical Performance Criteria: | |
| Sufficient image quality for diagnostic use by a trained physician | Met (confirmed by a U.S. Board Certified radiologist) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the clinical performance testing.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that images were "Acquired." Given the context of FDA clearance for a medical device, it's generally expected to be prospective data collected for regulatory submission, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document states "a U.S. Board Certified radiologist." This implies only one expert was used for the clinical image quality assessment.
- Qualifications of Experts: The expert was a "U.S. Board Certified radiologist." No information about their years of experience is provided.
4. Adjudication Method for the Test Set
- Adjudication Method: There was no explicit adjudication method described. With only one radiologist assessing image quality, there's no need for an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported or conducted. The clinical performance testing focused on assessing image quality by a single radiologist, not on comparing reader performance with or without AI assistance. The device is an MRI coil, not an AI software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil), not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product. The testing focused on the image quality produced by the coil.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical performance assessment was the subjective interpretation of "sufficient quality for diagnostic use" by a U.S. Board Certified radiologist. This is expert consensus (albeit from a single expert). It is not based on pathology, outcomes data, or a complex consensus process.
8. The Sample Size for the Training Set
- This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil). Hardware devices typically do not have "training sets" in the context of machine learning or AI models. Their performance is validated through engineering tests and clinical image quality assessment.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason 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.