(120 days)
For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
The Toshiba 1.5T Extra Large Knee Coil is designed for use with the with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.
This device is a Toshiba 1.5T Extra Large Knee Coil, intended for use with specific Toshiba 1.5T MRI scanners to produce diagnostic images of the knee. The provided document is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new AI/software device.
Therefore, many of the requested categories related to AI/algorithm performance and clinical validation studies are not applicable to this submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Device Performance |
|---|---|
| Safety: Device compliance with IEC 60601-1 (general medical electrical equipment safety). | Found compliant with IEC 60601-1 (1988 plus Amendments 1 & 2). |
| Safety: SAR compliance with IEC 60601-2-33 (MRI specific safety). | SAR complies with IEC 60601-2-33 (2002 plus Amendment 1). |
| Performance (Imaging Quality): Signal-to-noise ratio (SNR) measured according to internal protocol. | SNR was measured according to Toshiba Medical Systems Corporation's internal protocol. (Specific numerical values or comparison to predicate SNR are not provided in this summary.) |
| Substantial Equivalence: Same intended use, similar design, and constructed of similar materials as the predicate device. | The device has the same intended use (diagnostic images of the knee) and similar designs and materials to the predicate 1.5T QD Knee/Foot Coil (K051763). Enclosure materials cleared under K072935 and K093667. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a medical device for imaging, not an AI or software device that processes data for diagnosis and therefore does not have a "test set" in the context of an algorithm. The testing described focuses on engineering and safety standards.
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)
This is not applicable. Ground truth establishment by experts for image interpretation is not mentioned or relevant for this type of device submission, which is about the imaging coil itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable.
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
This is not applicable. This is a hardware component (MRI coil), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The "ground truth" for this device relates to its physical performance (safety, SNR) rather than diagnostic accuracy against a clinical reference.
8. The sample size for the training set
This is not applicable. The device is a hardware component; it doesn't utilize a training set in the AI sense.
9. How the ground truth for the training set was established
This 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.