(14 days)
The 16ch Foot/Ankle SPEEDER coil is intended for use with Canon 3.0T MR systems to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.
The 16ch Foot/Ankle SPEEDER is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using Canon 3.0T MR systems. The 16ch Foot/Ankle SPEEDER is intended to be used for foot and ankle imaging.
The 16ch Foot/Ankle SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in either a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility, or fire-rated flexible flaps that do not come into direct contact but can be easily adjusted to accommodate patients.
The provided text describes a 510(k) premarket notification for a medical device (16ch Foot/Ankle SPEEDER) and does not contain information about a study proving the device meets acceptance criteria related to an AI/algorithm's performance.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a physical MRI coil. The performance data discussed relates to:
- Biocompatibility Testing: Ensuring materials in contact with the patient are safe.
- Electrical Safety and Electromagnetic Compatibility: Conformance to safety standards (AAMI/ANSI ES60601-1 and IEC 60601-2-33), and surface heating tests (measured temperature never exceeded 41°C).
- Performance Testing - Bench: Signal-to-Noise Ratio (SNR) and uniformity analyzed per NEMA MS 6 and NEMA MS 9, conforming to predetermined acceptance criteria.
- Performance Testing - Clinical: Obtaining diagnostic quality images from volunteer scanning.
Therefore, many of the requested items (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training) are not applicable to this document as it does not describe an AI/algorithm-based diagnostic device or a study involving such.
Based on the available information, here is a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | All surface materials have a history of safe use. |
| Electrical Safety (AAMI/ANSI ES60601-1) | Verified in accordance with the standard. |
| EMC (IEC 60601-2-33) | Verified in accordance with the standard. |
| Surface Heating (Max 41°C) | Measured temperature never exceeded 41°C. |
| SNR (NEMA MS 6) | Conformed to predetermined acceptance criteria. |
| Uniformity (NEMA MS 9) | Conformed to predetermined acceptance criteria. |
| Diagnostic Image Quality | Produced diagnostic quality images of the intended anatomy |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "clinical images from volunteer scanning of the foot and ankle were obtained". It does not specify the number of volunteers (sample size) or the country of origin of the data. The data collection was prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not an AI/algorithm device requiring expert ground truth for "truth" labels. The "ground truth" for the device's performance is its ability to produce diagnostic quality images, interpreted by a "trained physician".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Image interpretation is stated to be by "a trained physician", implying standard clinical practice rather than a formal adjudication process for a study.
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, an MRMC study was not done. This device is a passive MRI coil and does not involve AI assistance for image interpretation.
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. This device is a physical MRI coil.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The implicit "ground truth" for the clinical performance relates to the ability of the images produced by the coil to be "diagnostic quality images of the intended anatomy" and "interpreted by a trained physician". This suggests a clinical judgment of image utility rather than a specific pathological or outcomes-based ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established
- 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.