(81 days)
Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Infant Coil - 24 is a 24 channel receive-only RF coil designed for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Foot & Ankle Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24 are receive-only multichannel phased array coils designed for use with UIH 3T MRI systems. The suffix number in coil name stands for the receive channel of the resonant nucleus is hydrogen protons (1H). All coil elements are protected from transmit field by both active and passive decoupling circuits. Each coil is designed to provide optimum image quality for its dedicated human anatomy region as defined in intended use.
The provided text is a 510(k) summary for several MRI coils manufactured by Shanghai United Imaging Healthcare Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data and does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria in the context of diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text, with an acknowledgment of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task. Instead, the "performance" demonstrated for these MRI coils relates to their technical imaging capabilities and adherence to safety and image quality standards.
The non-clinical tests performed, and their implied "acceptance criteria" are that the devices perform "as expected" and are "substantially equivalent" to predicate devices. The "reported device performance" is essentially their successful compliance with these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Electrical Performance: | Compliant: Meets requirements of ES60601-1:2005/(R)2012 and IEC 60601-2-33 Ed. 3.1:2013 |
| Biocompatibility: | Compliant: Meets requirements of ISO 10993-5:2009 and ISO 10993-10:2010 |
| Image Quality (Technical): | Compliant: Meets requirements for SNR and uniformity as per MS 1-2008(R2014), MS 3-2008(R2014), MS 6-2008(R2014), and MS 9-2008(R2014). Generates "diagnostic quality images." |
| Substantial Equivalence: | Achieved: Devices found substantially equivalent to predicate devices based on non-clinical tests and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Sample clinical images were provided to support the ability of the proposed devices to generate diagnostic quality images." However, it does not specify the sample size of these clinical images, nor does it provide details about their provenance (e.g., country of origin, retrospective or prospective collection).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The text states that images, "When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis." However, it does not detail how ground truth was established for any specific diagnostic performance evaluation.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence of the coils themselves, not the impact of AI assistance on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The devices described are MRI coils, which are physical hardware components used to acquire images. They are not AI algorithms. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.
7. The Type of Ground Truth Used
The document describes the coils as producing images that, "When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis." This implies that the images are to be used in conjunction with a physician's expertise for diagnosis. For the "sample clinical images" provided, the type of ground truth is not specified. It's generally inferred that for diagnostic imaging devices, the gold standard would be expert clinical diagnosis, possibly correlated with pathology or outcomes where available, but this is not explicitly stated for these coils.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. Since these devices are MRI coils (hardware), there is no training set in the typical AI/ML sense. The non-clinical tests relate to engineering specifications and image quality measurements, not algorithm training.
9. How the Ground Truth for the Training Set was Established
As there is no training set for these hardware devices, this question is not applicable.
§ 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.