(84 days)
The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MR1 systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
The 1.5T 4CH Flex Coils are receive-only coils designed to provide images of various parts of human body. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
The 1.5T 4CH Flex coils are available in two models – 1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems.
1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers.
1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Healthcare 1.5T 4CH Flex Coil, structured to address your specific points:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with IEC60601-1, IEC60601-2-33, IEC60601-1-2. | The 1.5T 4CH Flex Coil complies with these voluntary standards. |
| Risk Management | Compliance with ISO14971 (Risk Analysis). | Risk Analysis was applied to the development of the system. |
| Biocompatibility | Compliance with ISO10993-1. | The 1.5T 4CH Flex Coil complies with this voluntary standard. |
| Design Integrity | Requirements Reviews and Design Reviews. | Requirements Reviews and Design Reviews were applied to the development of the system. |
| Performance Testing | General Performance testing. | Performance testing was applied to the development of the system. |
| Integration Testing | System Integration testing. | Integration testing was applied to the development of the system. |
| Electrical Safety | Safety testing. | Safety testing was applied to the development of the system. |
| RF Safety (B1 Peak) | Maximum B1 Peak test - verify coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown. | This test was performed to verify the coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown. (Implied successful completion to support substantial equivalence). |
| RF Safety (Blocking Network) | Blocking Network analysis - determine the effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion. | This test was performed to determine the effectiveness of the blocking networks for transmit decoupling to ensure safety and to minimize B1 distortion. (Implied successful completion to support substantial equivalence). |
| Thermal Safety | Surface temperature test under normal condition. | A surface temperature test was conducted under normal conditions. (Implied successful completion to support substantial equivalence). |
| Thermal Safety (Unplugged) | Surface temperature test under unplugged condition. | A surface temperature test was conducted under unplugged conditions. (Implied successful completion to support substantial equivalence). |
| Image Quality / Clinical | Produce diagnostic images of human anatomies, function as general purpose coils for shoulder, elbow, wrist, knee, hip, and ankle, and allow for flexible wrapping and planar imaging. Substantial equivalence to predicate device K030953 (GE 3.0T General Purpose Flex Coil). | Internal scans within GE Healthcare facility were performed to obtain sample clinical images. The device is considered as safe, as effective, and its performance is substantially equivalent to the predicate device(s) based on these internal images and the non-clinical tests. The coils are designed for the stated anatomies and use cases, producing diagnostic images. |
Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical count of patients or images. The text mentions "sample clinical images" were obtained.
- Data Provenance: The study involved "Internal scans within GE Healthcare facility." This indicates the data was likely prospective and collected specifically for this filing. The country of origin is implicitly India ("Wipro GE Healthcare Pvt Ltd, Bangalore, INDIA").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The filing focuses on technical and safety equivalence, with clinical images used internally for verification rather than a formal clinical trial with expert interpretation for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of the "internal scans" for "sample clinical images" and the absence of explicit expert review processes, it's highly probable that a formal adjudication method was not used in the context typically seen in AI device studies. The primary goal was to demonstrate image production and quality consistent with the predicate, not diagnostic accuracy against a ground truth.
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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, an MRMC comparative effectiveness study was not done. This submission is for a medical device (MRI coil), not an AI-assisted diagnostic tool. The document explicitly states: "The subject of this premarket submission, 1.5T 4CH Flex Coil did not require external clinical studies to support substantial equivalence."
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an MRI coil, which is a component of an imaging system, not a standalone algorithm or AI. Its performance is evaluated on its ability to acquire images, not to perform interpretations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "sample clinical images" obtained from internal scans, the concept of a formal "ground truth" (e.g., pathology, expert consensus on disease presence) in the context of diagnostic accuracy is not applicable or stated. The "ground truth" for the coil's performance was likely related to the expected image quality and signal-to-noise ratio compared to engineering specifications and the predicate device, demonstrated through visual inspection of the images themselves rather than an independent diagnostic gold standard.
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The sample size for the training set:
- Not applicable. This is a hardware device (MRI coil), not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
§ 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.