(85 days)
The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.
The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.
The provided text describes a 510(k) submission for a medical device, the Mayo Clinic BC-10 3.0T MR coil. This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a diagnostic algorithm.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable in this context. The document primarily details the device's technical specifications and intended use, comparing it to existing, legally marketed devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The provided summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm with sensitivity, specificity, etc. Instead, the "acceptance criteria" are implied to be that the device performs "in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards." The reported device performance is that it is "substantially equivalent to already approved extremity coils" and is a "proven design with well documented clinical, safety, and reliability data from years of use at the Mayo Clinic."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs in accordance with predetermined acceptance criteria | Substantially equivalent to already approved extremity coils |
| Safety and reliability meets/exceeds standards | Proven design with well documented clinical, safety, and reliability data |
| Accurately image maladies associated with hand, wrist, forearm, elbow | High SNR for small extremity imaging with 10cm FOV (compared to predicate) |
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 provided in the document for a formal test set in the context of proving diagnostic performance. The submission refers to "clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN," which suggests retrospective data from a U.S. institution, but specific sample sizes for particular tests are not detailed.
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 information is not provided as this is not a study evaluating a diagnostic image interpretation algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as this is not a study evaluating a diagnostic image interpretation algorithm.
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 information is not provided nor is it applicable, as the device is an MR coil, not an AI-powered diagnostic tool requiring human reader evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided nor is it applicable, as the device is an MR coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the context of a formal study with ground truth for a diagnostic outcome. The "clinical, safety, and reliability data" would likely refer to a combination of clinical observations, imaging characteristics, and potentially patient outcomes over time, but no specific method for establishing "ground truth" for a test set is described.
8. The sample size for the training set
This information is not provided as this refers to an MR coil, not an algorithm that undergoes a training phase.
9. How the ground truth for the training set was established
This information is not provided as this refers to an MR coil, not an algorithm that undergoes a training phase.
In summary: The provided document is a 510(k) summary for an MR coil, focusing on demonstrating substantial equivalence to existing devices. It does not contain the detailed information about clinical study design, performance metrics, ground truth establishment, or reader studies that would be expected for a diagnostic algorithm. The "study" mentioned generally refers to engineering tests and the accumulated clinical use data at Mayo Clinic, rather than a specific clinical trial designed to prove diagnostic performance through a test set.
§ 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.