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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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