(41 days)
The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
The provided text is a 510(k) Summary for the Flex Body SPEEDER and describes performance testing for substantial equivalence. However, it does not explicitly detail acceptance criteria and a study design in the format of an AI/human-in-the-loop diagnostic device study. The device is a receive-only, phased array coil for MRI, not an AI-powered diagnostic device that interprets images. Therefore, the questions related to AI performance metrics (e.g., standalone AI performance, MRMC studies, ground truth establishment for training/test sets, sample sizes for training/test sets, expert adjudication, effect size of AI assistance) are not directly applicable to this submission.
Instead, the performance data provided focuses on the physical and functional aspects of the MRI coil.
Here's an attempt to answer the relevant questions based on the provided text, while acknowledging the limitations for questions pertaining to AI diagnostic studies:
1. A table of acceptance criteria and the reported device performance
The document mentions that the SNR and uniformity were analyzed per NEMA MS-6 and NEMA MS-9 and found to conform to predetermined acceptance criteria, but it does not explicitly state the numerical acceptance criteria or the reported numerical performance values for SNR and uniformity.
| Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance |
|---|---|
| Electrocution (AAMI/ANSI ES60601-1) | Compliant |
| Heating (AAMI/ANSI ES60601-1) | Measured temperature of the surface of the coil never exceeded the maximum limit of 41°C. |
Electrostatic Discharge Immunity (IEC 60601-1-2 Ed 4.0 (2014)) | Compliant |
| SNR (NEMA MS-6) | Conformed to predetermined acceptance criteria |
| Uniformity (NEMA MS-9) | Conformed to predetermined acceptance criteria |
| Diagnostic Image Quality (Clinical Images) | Produces diagnostic quality images of the intended anatomies |
2. Sample size used for the test set and the data provenance
The document states, "clinical images from volunteer scanning of general human anatomy were obtained from the Flex Body SPEEDER."
- Sample size: Not explicitly stated, but implies a "volunteer scanning" was conducted, indicating a small clinical dataset for qualitative assessment.
- Data provenance: Not explicitly stated, but typically clinical image acquisition for such submissions is done in a controlled site, likely in the same country as the manufacturer (USA, given the FDA submission). It's a prospective data acquisition from "volunteer scanning."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device does not involve expert interpretation to establish "ground truth" in the sense of a diagnostic finding (e.g., presence/absence of disease) for an AI algorithm. Instead, the "ground truth" here is the qualitative assessment of image quality for diagnostic use by a "trained physician."
- Number of experts: Not specified.
- Qualifications of experts: "Trained physician." Their specific experience (e.g., years, specialization) is not detailed.
4. Adjudication method for the test set
Not applicable in the context of adjudicating diagnostic labels, as this is an image acquisition device, not a diagnostic interpretation device. The "adjudication" implied is that the images "can be interpreted by a trained physician," implying they are deemed suitable for clinical diagnosis. No formal multi-reader adjudication process like 2+1 or 3+1 is described.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" concept for this device relates to diagnostic image quality. The assessment was that the "Flex Body SPEEDER produces diagnostic quality images of the intended anatomies." This is based on qualitative assessment by a "trained physician" (implied "expert review") of the images' suitability for diagnostic interpretation, rather than a specific disease outcome or pathology.
8. The sample size for the training set
Not Applicable. The device does not involve an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. The device does not involve an AI algorithm that requires a training set with established ground truth.
§ 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.