(23 days)
Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above. The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.
Acceptance Criteria and Study Details for the 4ch Flex SPEEDER
The provided document describes the 4ch Flex SPEEDER, a phased array coil for Magnetic Resonance Diagnostic Devices. The document is a 510(k) Summary of Safety and Effectiveness, aiming to demonstrate substantial equivalence to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the 4ch Flex SPEEDER, as is common for medical device accessories demonstrating substantial equivalence, does not explicitly state quantitative acceptance criteria or provide a table of performance metrics in the same way a de novo device might. Instead, its primary method of demonstrating equivalency is through comparing its intended use, design, and performance characteristics to legally marketed predicate devices.
The document states: "Sample phantom images and clinical images are presented in Appendix F & G of this submission." This indicates that visual assessment of image quality from both phantom and clinical studies was submitted to demonstrate performance equivalent to the predicate devices. The implicit acceptance criterion is that the image quality (resolution, signal-to-noise ratio, artifact levels, etc.) produced by the 4ch Flex SPEEDER, as evidenced by these sample images, is comparable to, and not worse than, the image quality of the predicate devices.
Since specific quantitative metrics are not provided in this summary, a table for acceptance criteria vs. reported performance cannot be generated with numerical values. However, based on the submission's structure, we can infer the qualitative performance assessment:
| Performance Aspect | Implicit Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Image Quality (Phantom) | Comparable to predicate devices (Atlas SPEEDER Body [K063361] and φ200 flex coil [K060003]) in terms of signal-to-noise, uniformity, and artifact levels. | Sample phantom images provided in Appendix F show image quality consistent with predicate devices. |
| Image Quality (Clinical) | Diagnostic quality images for the specified anatomical regions (extremities, joints, trunk) comparable to predicate devices. | Sample clinical images provided in Appendix G demonstrate diagnostic quality imaging across various anatomical regions. |
| Safety Parameters | Compliance with specified maximum static field strength, dB/dt, and SAR as per IEC60601-2-33 (2002). Biocompatibility of patient-contacting materials. | Device meets stated safety parameters: Maximum static field 1.5 T, 1st operation mode for dB/dt and SAR per IEC60601-2-33 (2002), and biocompatibility confirmed by material history or test data. |
| Mechanical Flexibility/Fit | Ability to wrap around various regions (extremities, joints, trunk) effectively. | Device is "mechanically flexible, and can wrap around various regions as mentioned above." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for a formal test set in terms of number of patients or images. It mentions "Sample phantom images and clinical images are presented in Appendix F & G." This suggests a qualitative, rather than large-scale quantitative, comparison for equivalence.
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The 510(k) summary does not mention the use of experts to establish ground truth for a test set. This type of review by experts is more common for software algorithms or AI devices where diagnostic accuracy is explicitly being measured against a gold standard. For a coil accessory demonstrating substantial equivalence, the focus is typically on the physical and electrical performance leading to acceptable image quality.
4. Adjudication Method
Given that no formal test set with ground truth establishment by experts is described, there is no adjudication method mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the 510(k) summary. The device is a hardware accessory (an MRI coil), not an AI algorithm or a diagnostic software tool that directly interprets images. Therefore, the concept of improving human reader performance "with AI vs without AI assistance" is not applicable to this device submission.
6. Standalone Performance Study
The focus of this submission is on the standalone performance of the 4ch Flex SPEEDER as an MRI coil, rather than its performance in conjunction with an AI. The "sample phantom images and clinical images" would reflect the standalone performance of the coil when integrated into a standard MRI system. However, the summary does not detail the methodology or metrics of such a study beyond mentioning the provision of images.
7. Type of Ground Truth Used
For a hardware component like an MRI coil, the "ground truth" for image quality is typically established by physical phantom measurements (e.g., signal-to-noise ratio, uniformity, resolution targets) and the assessment of clinical diagnostic utility by qualified radiologists (though not explicitly detailed in this summary). There is no mention of pathology or outcomes data being used for ground truth in this submission.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. Since the 4ch Flex SPEEDER is a hardware coil, there is no training set in the context of an algorithm. Its design and development would have involved engineering specifications, simulations, and iterative prototyping and testing, not data training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this hardware device, 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.