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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.

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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.

The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System (K002242). It improves imaging of selected sections of the head and extremities.

The FlexiCoil is a malleable receive-only surface coil intended to facilitate intraoperative MR imaging of selected sections of the head and extremities. This component is a malleable circular enclosed coil that consists of copper straps covered with Medical Foam Tape and an electronic tuning box, which can be placed around the anatomy of interest for MR imaging. The malleable structure of the coil allows adjustment of size and shape by pulling/releasing the plastic holders on both sides of the coil, providing the highest possible contact between the coil and the area to be imaged.

Due to its malleability the FlexiCoil can cover a wider area than the presently used coils (K991243) resulting in better image uniformity and a better overall SNR when imaging structures near the surface of the patient's head or extremity. The improved SNR is a result of the coil being closer to the signal-emitting anatomy, and being fully tuned and matched to the signal and receive channel. In addition the coil can be easily placed near the anatomy to be imaged with little or no patient post procedure discomfort. The FlexiCoil is for single use only and is supplied non-sterile.

The provided 510(k) summary for the FlexiCoil - malleable receive-only surface coil does not contain a detailed study report with acceptance criteria and specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, and mentions "Performance Data: Sample images were provided in attachment 4 of the 510(k) submission." This indicates a qualitative assessment or side-by-side comparison of image quality rather than quantitative performance against predefined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI.
• Standalone (algorithm only) performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• The sample size for the training set.
• How the ground truth for the training set was established.

Based on the provided document, the device met the acceptance criteria by demonstrating substantial equivalence, not through a formal study with predefined quantitative acceptance metrics.

The document states:
"Substantial equivalence was based on performance data. Sample images were provided in attachment 4 of the 510(k) submission."
And:
"The PoleStar N-10 operated with the FlexiCoil - malleable receive-only surface coil adressed in this premarket notification, has the same intended use and technological characteristics as the same system operated with the legally marketed coil cleared in K991243 and does not affect the PoleStar N-10 system safety parameter specification. The FlexiCoil also has the the same intended use and technological characteristics as the other OEM predicate coil."

This indicates that the "performance data" likely involved a comparison of images produced by the FlexiCoil with those from the predicate devices to show similar image quality and diagnostic usefulness, rather than meeting specific quantitative performance thresholds. The FDA's clearance is based on this demonstration of substantial equivalence.

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