(119 days)
The 16Ch Diagnostic Breast Coils are indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images and/ or spectra, and that displays the internal structure of the breast. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
The 16Ch Diagnostic Breast Coil (1.5 T 16Ch Diagnostic Breast Coil and 3.0 T 16Ch Diagnostic Breast Coil) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a receive-only coil for high resolution MR examination of breast.
The coil housing features a curved surface for better adaption to the anatomical region of interest. The coil is receive-only (Rx) and consists of 16 independent single loop coil elements with integrated low noise preamplifiers and a connector to the GE 1.5 T MR Systems or the GE 3.0 T MR Systems. The coil is fixed tuned and matched to the typical load of a breast at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz) respectively. Decoupling circuits are integrated in each single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse. The coil provides both, unilateral and bilateral images (Left, Right and Both) of the anatomy of interest.
The provided document is a 510(k) premarket notification for a magnetic resonance breast coil accessory, not a detailed study report for an AI device. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML clinical validation.
Here's an analysis of what can be extracted and what information is missing:
Information Extracted:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit from regulatory standards): The device adheres to safety and performance parameters outlined in the FDA Guidance Document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued on Nov. 18, 2016." It also conforms to specific international standards for medical electrical equipment (AAMI/ANSI ES60601-1, IEC 60601-2-33) and NEMA standards for MRI coil performance (MS 6-2008, MS 9-2008).
- Reported Device Performance:
- Nonclinical Tests (Loading phantom): "Test results show an enhanced SNR performance of the subject device, while determined Image Uniformity compares well to the results from the predicate device."
- Clinical Tests (Volunteers): "Clinical test show that the subject device provides adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good."
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for non-clinical (phantom) or clinical (volunteer) tests.
- Data Provenance: Clinical tests were performed on "volunteers." No country of origin is specified. The tests appear to be prospective, as they were "performed... in order to check image quality in vivo."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided. This device is an MRI coil, not an AI diagnostic algorithm, so there's no mention of "ground truth" derived from expert consensus for diagnostic accuracy. The "indications for use" state images "when interpreted by a trained physician, yield information that may assist in diagnosis," but this refers to the end-user, not experts establishing ground truth for a study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not provided for the reasons stated above.
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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:
- No MRMC study was mentioned. The device is a breast coil, not an AI assistance tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used:
- Not applicable in the typical sense of AI/ML validation (e.g., pathology, outcomes data). The evaluation criteria for this MRI coil focused on technical image quality parameters (e.g., SNR, uniformity, contrast, resolution, artifacts) and patient comfort.
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The sample size for the training set:
- Not applicable; this is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable; no training set.
Summary of Missing Information for AI/ML Context:
The document is a premarket notification for an MRI coil, a hardware accessory. The information requested in the prompt, such as "number of experts," "adjudication method," "MRMC study," "standalone performance," "training set," and "ground truth establishment" (in the context of diagnostic accuracy), are standard requirements for the validation of Artificial Intelligence/Machine Learning (AI/ML) powered diagnostic devices or software. This document is not for such a device, and therefore these details are not present.
§ 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.