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The PoleStar system is a magnetic resonance diagnostic device 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 StarShield V3 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 system.

The StarShieldV3 is an accessory of Odin's PoleStar Intraoperative Magnetic Resonance system. It is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent, required Elootromagnotion The RF Tent is a portable modular structure that consist of four principal components:

• The foldable frame .
• The cover .
• The control unit .
• The floor .

The RF Tent is not connected to the PoleStar gantry or the OR table.

The provided text is a 510(k) summary for the StarShield V3 device, which is an accessory to an Intraoperative Magnetic Resonance system. The submission aims to demonstrate substantial equivalence to a predicate device (Odin's RF Tent). The primary function of the StarShield V3 is to reduce Electromagnetic Interference (EMI) during MRI image acquisition.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for the StarShield V3 in the typical sense of performance metrics with thresholds. Instead, it provides a "Substantial Equivalence Comparison Table" that lists parameters of the StarShield V3 and compares them to its predicate device, the RF Tent (K022157). The implicit acceptance criterion is that the StarShield V3 performs equivalently to the predicate device in terms of EMI reduction.

Note regarding "Acceptance/Performance": For most parameters, "Same" indicates the StarShield V3 meets the performance of the predicate by having identical specifications. For "Average Attenuation," the ">40dB at 100 MHz" is a specific performance metric that the StarShield V3 also claims as "Same," implying it meets or exceeds this level of attenuation. The only notable difference is "Energy used," which changed from pneumatic to electric, but the document implicitly suggests this change does not affect the substantial equivalence in terms of the primary function (EMI reduction).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide information on a test set, its sample size, or data provenance. This 510(k) submission is for a physical medical device (an EMI shielding tent), not a software or diagnostic algorithm that would typically require a dataset to evaluate its performance. The "study" here is primarily a comparison of specifications and physical attributes to a predicate device.

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 this is a physical device intended for EMI reduction, there is no "ground truth" derived from expert consensus on medical images or diagnoses. The performance is based on engineering specifications (e.g., attenuation levels).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no test set requiring expert adjudication.

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 not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its purpose.

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

Not applicable. The StarShield V3 is a physical accessory, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the StarShield V3's performance, as implied by the comparison table, is based on engineering specifications and measurements related to EMI attenuation. The predicate device (RF Tent) established a benchmark of ">40dB at 100 MHz" for average attenuation. The StarShield V3 is declared to have the "Same" attenuation, meaning it is expected to meet this engineering standard.

8. The sample size for the training set

Not applicable. This device is not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this device.

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The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*.

Anatomical regions: extremities and selected sections of the head.

Nuclei excited: H-1

Diagnostic uses: T1, T2, T2* and density weighted imaging.

The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.

The PoleStar N-20 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The PoleStar N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.

This document is a 510(k) summary for the Odin Medical Technologies PoleStar N-20, an intraoperative MRI device. The primary claim for substantial equivalence is based on a comparison to the predicate device, Odin's PoleStar N-10. This filing does not describe a study to prove acceptance criteria for device performance. Instead, it focuses on demonstrating that the PoleStar N-20 is substantially equivalent to an existing device (the PoleStar N-10) based on similar technical specifications and identical intended use.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and statistical analysis is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide explicit "acceptance criteria" for performance that would typically be seen in a clinical validation study for a new diagnostic device. Instead, it offers a "Substantial Equivalence Comparison Table" that lists technical specifications of the new device (PoleStar N-20) against its predicate (PoleStar N-10). The "performance" in this context refers to these specifications matching or being comparable to the predicate.

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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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