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510(k) Data Aggregation
(29 days)
The Toshiba 3T Extra Large Knee Coil is intended for use with a Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the knee that can be interpreted by a trained physician.
The Toshiba 3T Extra Large Knee Coil is designed for use with the Toshiba Vantage Titan 3T MRI system manufactured by Toshiba Medical Systems Corporation.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988 plus Amendments 1 (1991) and 2 (1995)) compliance | The Toshiba 3T Extra Large Knee Coil was tested to and found compliant with IEC 60601-1. |
| IEC 60601-2-33 (Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis, 2002 plus Amendment 1 (2005)) compliance for SAR | The coil SAR complies with the requirements of IEC 60601-2-33. |
| Signal-to-noise ratio (SNR) measurement according to Toshiba Medical Systems Corporation's internal protocol | SNR was measured according to Toshiba Medical Systems Corporation's internal protocol. Specific values are not provided in this document, but the device is considered substantially equivalent, implying satisfactory performance based on internal protocols. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a clinical study involving a test set of patient data. The non-clinical tests reported are for device safety and performance standards rather than diagnostic efficacy with patient data.
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 no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication 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
Not applicable. This submission is for an MRI coil, not an AI-powered diagnostic device, and thus no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an MRI coil, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring ground truth is described. The "ground truth" for the non-clinical tests were the established international and corporate standards for safety and performance.
8. The sample size for the training set
Not applicable, as no machine learning algorithm is involved.
9. How the ground truth for the training set was established
Not applicable, as no machine learning algorithm is involved.
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