Search Results

The RF Tent is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar N-10 (K002242).

To acquire high-quality MR images. it is necessary to isolate the MRI scanner from external sources of EMI (Electromagnetic Interference). Generally, copper sheeting is installed in the OR walls to isolate the OR from external interference. This solution is relatively expensive, and also requires the OR to be out of use during the installation process. Once the copper sheeting is installed, all procedures involving the PoleStar N-10 intraoperative MRI must be performed in the dedicated shielded room.

The RF Tent presented in this premarket notification expands the capability of the PoleStar N-10 (K002242), by providing a low cost, simple and effective alternative to the fixed copper shielding. Because it is portable, it also allows the PoleStar N-10 to be used in more than a single dedicated OR. Thereby increasing the flexibility of the use of the system.

The provided text describes the "RF Tent" device, which is an accessory designed to reduce Electromagnetic Interference (EMI) during MRI image acquisition. The document focuses on its substantial equivalence to existing solutions (installed copper sheeting) rather than providing detailed acceptance criteria and a comprehensive study report in the format typically seen for algorithm-based devices.

Therefore, many of the requested fields cannot be directly populated from the provided text because the device is a physical RF shielding enclosure, not an AI/algorithm-based diagnostic device. The performance data section is very brief.

Here's an attempt to extract the available information and indicate where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Test Set Sample Size: Not explicitly stated. The "Performance Data" section refers to "Signal to Noise results" (plural), suggesting multiple data points or tests were conducted, but the number of tests or specific scenarios is not given.
• Data Provenance: Not explicitly stated. The tests were performed by "Odin Medical Technologies." It's likely conducted in a controlled lab or clinical setting, but country of origin or whether it's retrospective/prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

• This information is not applicable and not provided. The "ground truth" for an RF shielding device would be based on objective physical measurements of EMI attenuation and Signal-to-Noise Ratio (SNR) in MR images, not expert interpretation of diagnostic images.

4. Adjudication method for the test set

• Not applicable and not provided. See point 3 above.

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 device is an RF shielding enclosure, not an AI or diagnostic algorithm that human readers would interact with. No MRMC study was performed or discussed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

• The implicit ground truth is based on physical measurements of Electromagnetic Interference (EMI) attenuation and resulting Signal-to-Noise Ratio (SNR) in Magnetic Resonance (MR) images. The text mentions "Signal to Noise results" as performance data.

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is a physical device, not a machine learning model.

Ask a specific question about this device