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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.

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

• Not Applicable. This document does not describe a clinical study with a test set of data. The substantial equivalence is based on technical specifications and intended use comparison.

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. No ground truth establishment is described as there is no clinical test set in this filing. The filing mentions that "When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis," which refers to the eventual use of the device, not a study performed for this 510(k).

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

• Not Applicable. No test set or adjudication method is 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:

• No. This document describes an MRI diagnostic device, not an AI or CAD system, and therefore, an MRMC study related to AI assistance would not be relevant or expected for this device.

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

• No. This is a hardware device (MRI scanner) which requires human operation and interpretation. The concept of standalone algorithm performance does not apply.

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

• Not Applicable. As no clinical study or test set is described, no ground truth was established for this 510(k filing for the PoleStar N-20.**

8. The sample size for the training set:

• Not Applicable. This document does not describe a machine learning or AI-based device that would require a training set.

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

• Not Applicable. No training set or ground truth for a training set is described.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of the PoleStar N-20 to its predicate, the PoleStar N-10, by comparing technical specifications and intended use. It does not include information about performance acceptance criteria validated through a clinical study with a test set, expert ground truth establishment, or AI-related metrics.

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