Search Results
Found 1 results
510(k) Data Aggregation
(98 days)
The Mayo Clinic BC-10 1.5T 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.
Due to the nature of the provided document, which is a 510(k) summary for a medical device (a dedicated MRI coil), it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report comparing the performance of an AI algorithm to established acceptance criteria. Therefore, most of the requested information regarding AI algorithm performance and study methodology is not present in the document.
However, I can extract the available information related to the device's performance and the general nature of the testing mentioned.
Here's a breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document states: "Testing was performed to demonstrate the Mayo Clinic BC-10 performed in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards." However, the specific pre-determined acceptance criteria or numerical reported device performance are not detailed in this summary. The summary focuses on comparing features to predicate devices.
| Feature | Mayo Clinic BC-10 (Reported Performance - as presented in comparison) | Acceptance Criteria (Not explicitly stated numerically in this summary) |
|---|---|---|
| Coil Type | High-pass, quadrature, T/R | Performance in line with "high-pass, quadrature, T/R" coil characteristics for MRI applications, demonstrating safety and reliability. |
| Region of Interest | Small extremities < 10cm | Effective imaging of small extremities with a diameter less than 10cm, including hand, wrist, forearm, and elbow. |
| Compatibility | All Signa 1.5T MR systems | Compatibility with all GE Signa 1.5T MR systems. |
| Tuning | No external tuning necessary. Coil is optimized for small extremity anatomy. | No external tuning required, with optimized performance for small extremity anatomy. |
| Patient Positioning | Overhead or at patient's side | Allows for patient positioning overhead or at the patient's side. |
| Imaging Configuration | High SNR for small extremity imaging with 10cm FOV. | Achieves high Signal-to-Noise Ratio (SNR) for small extremity imaging within a 10cm Field of View (FOV). Specifically, to "accurately image a variety of maladies" as per indications for use. |
2. Sample sized 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 510(k) summary. The document mentions "testing was performed" and refers to "well documented clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN" but does not specify sample sizes or whether the testing was retrospective or 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)
This information is not provided in the 510(k) summary. The document describes a physical medical device (an MRI coil), not an AI algorithm requiring expert-established ground truth for its performance evaluation in that sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary. It's not relevant for the type of device and study 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
An MRMC study is not mentioned and is not relevant to this type of device (an MRI coil). The device itself is an imaging component, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an MRI coil, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an MRI coil, "ground truth" would refer to the physical and electrical performance measurements of the coil, and its ability to produce diagnostically acceptable images. The implicit ground truth would be established engineering standards and clinical expectations of image quality for an MRI system. The document does not specify the exact methods for establishing this ground truth, beyond referencing "standards" and "well documented clinical, safety, and reliability data from years of use".
8. The sample size for the training set
This is not applicable as the device is an MRI coil, not an AI algorithm that undergoes a training phase.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
In summary:
The provided document is a 510(k) summary for an MRI coil, demonstrating substantial equivalence to predicate devices based on design and general performance characteristics. It is not a study report for an AI-powered diagnostic algorithm, and as such, most of the questions related to AI study methodology cannot be answered from this text. The "study" referenced is general testing to ensure the coil met "predetermined acceptance criteria" for safety and reliability, likely involving engineering and image quality assessments, rather than evaluating AI performance against ground truth.
Ask a specific question about this device
Page 1 of 1