(28 days)
The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.
The Siemens 3.0T Blanket Array Coil embeds an MRI antenna set within a quilt-like enclosure providing high-quality images of general human anatomy. It is flexible enough to wrap snuggly around small bodies as well as large adult extremities so it can be used to image those challenging regions such as bilateral brachial plexus, bilateral lower extremities, and even heads. This lightweight SemiFlex™ design facilitates effortless and accurate positioning and ensures the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The Blanket Array Coil is an MRI coil contained within a water-resistant case, featuring a soft and cleanable cover. What the patient feels is a lightweight, warm and soothing blanket. What the radiologist sees is a flawless image without compromising comfort. The underlying technology and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.
I'm sorry, but the provided text does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving a device meets them. The document is primarily a 510(k) summary for a Siemens 3.0T Blanket Array Coil, focusing on its substantial equivalence to a predicate device, rather than a clinical study report with specific acceptance criteria and detailed performance metrics.
Here's what can be extracted and why other parts of your request cannot be answered:
Device Information:
- Trade/Device Name: Siemens 3.0T Blanket Array Coil (Model 516SI3001)
- Regulation Number/Name: 21 CFR 892.1000, Magnetic resonance diagnostic device
- Product Code: MOS
- Intended Use: "The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis."
Missing Information:
The document describes non-clinical tests and a mention of "clinical tests" but does not provide specific acceptance criteria, reported device performance metrics against such criteria, sample sizes, provenance of data, details about expert involvement in ground truth establishment or adjudication, MRMC studies, or standalone algorithm performance.
Explanation for Missing Information:
-
Acceptance Criteria and Reported Device Performance: While the document mentions "SNR and uniformity analysis" as a non-clinical test, it does not state specific numerical acceptance criteria (e.g., "SNR must be >X dB") nor does it present the quantitative results of these analyses as "reported device performance." The substantial equivalence decision relies on the similarity of the performance to the predicate, not on meeting predefined numerical targets that would typically be seen in a clinical trial with specific endpoints.
-
Sample Size for Test Set and Data Provenance: The document states that "Analyses in all 3 planes (sagittal, coronal, and axial) were run on the Siemens 3.0T Blanket Array Coil to show that the anatomies of the submitted and predicate coils have substantial equivalence." This statement is extremely vague and does not provide any information about the number of cases (sample size), patient demographics, or whether the data was retrospective or prospective, or its country of origin.
-
Number/Qualifications of Experts for Ground Truth: No information is provided regarding the use of experts to establish a "ground truth" for the test set. The study described seems to be more about demonstrating technical equivalence in imaging quality rather than diagnostic accuracy against a definitive ground truth. The indication for use mentions images being interpreted by a "trained physician," but this is a general statement, not a detail of the validation study.
-
Adjudication Method: Not applicable, as there's no mention of a formal expert review or ground truth establishment process involving multiple experts and adjudication.
-
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The focus is on comparing the technical characteristics and imaging capabilities of the new coil to a predicate device, not on how human readers perform with or without the device's assistance.
-
Standalone Performance: The device is an MRI coil, an accessory to an MRI scanner, and does not operate as a standalone algorithm or device in a diagnostic sense. Its performance is intrinsically linked to the overall MRI system and the interpretation by a physician.
-
Type of Ground Truth Used: Based on the description, the "ground truth" appears to be the visual quality and anatomical depiction in the images, compared to the predicate device. It's not pathology, outcomes data, or expert consensus on diagnosis.
-
Sample Size for Training Set: This device is hardware (an MRI coil), not a software or AI algorithm that requires a "training set."
-
How Ground Truth for Training Set was Established: Not applicable, as it's not an AI/ML device.
In summary, the provided document is a 510(k) summary for a medical device (an MRI coil) seeking substantial equivalence based on technical characteristics and imaging capabilities, not a clinical trial report for an AI/ML diagnostic device that would typically include the requested details about acceptance criteria, ground truth, and reader studies.
§ 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.