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The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images can provide diagnostically useful information.

neuro42 MRI System is a low-field MR system intended to be used for neuroimaging. The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device intended to be used for producing images that display the internal structure of the head. The device is a low-field magnetic resonance system and includes a movable magnet cart on wheels connected to a separate electronic cabinet on wheels. The system utilizes a permanent Halbach magnet array and does not require any external shielding.

The provided text is a 510(k) Summary for the neuro42 MRI System. It details the device's indications for use, description, classification, comparison to a predicate device, and a summary of testing. However, it does not contain information about acceptance criteria for device performance based on image quality or diagnostic accuracy, nor does it describe a specific study proving the device meets such criteria.

The text states: "No clinical trials were performed. Sample clinical images were provided to support substantial equivalence." This means there was no human diagnostic performance study (like an MRMC study) described within this document to establish diagnostic accuracy or compare human reader performance with and without AI.

Therefore, many of the requested items cannot be extracted from this document, as the FDA clearance was based on non-clinical performance and a comparison to a predicate device, rather than a clinical performance study with defined acceptance criteria for diagnostic output.

However, I can extract information regarding the technical performance and the type of testing conducted.

Here's what can be inferred and what is explicitly stated:

Information Not Available from the Provided Text:

• A table of acceptance criteria and the reported device performance regarding diagnostic accuracy or image interpretability by human readers. (No clinical trials or diagnostic performance studies are described.)
• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective). (No described test set for diagnostic performance.)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts. (Not applicable as no diagnostic performance study was conducted.)
• Adjudication method (e.g., 2+1, 3+1, none) for the test set. (Not applicable as no diagnostic performance study was conducted.)
• 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. (Explicitly stated: "No clinical trials were performed.")
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (Not specified, implies the device produces images for human interpretation, not an AI diagnostic algorithm.)
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.). (Not applicable as no diagnostic performance study was conducted.)
• The sample size for the training set. (Not applicable, as no AI model training is described for diagnostic purposes.)
• How the ground truth for the training set was established. (Not applicable, as no AI model training is described for diagnostic purposes.)

Information Available or Inferable from the Provided Text:

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical and safety performance of the MRI system itself, based on recognized standards, rather than its diagnostic accuracy in a clinical setting with human readers.

1. A table of acceptance criteria and the reported device performance (based on technical standards):

The document lists several technical standards that the neuro42 MRI System has been "evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification and validation, and image quality." It states the device "has been found to conform" to these standards. The specific performance values against these standards are not detailed in a table format in the provided text.

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

• Sample Size: Not explicitly stated for the "sample clinical images" provided. These images were used to "support substantial equivalence," implying a qualitative assessment rather than a quantitative performance study with a defined sample size. These are likely images acquired during system development and testing, not a formal clinical trial dataset.
• Data Provenance: Not specified (country of origin, retrospective/prospective).

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 for the type of testing described (which is technical compliance and qualitative image review, not diagnostic accuracy). The device produces images "interpreted by a trained physician," implying the human physician provides the diagnostic ground truth in clinical use, but this was not part of the clearance study.

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

• Not applicable due to the absence of a diagnostic performance study.

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 MRMC study was done. The document explicitly states: "No clinical trials were performed." The device does not appear to incorporate AI for image interpretation or diagnosis. It is an MRI system for image acquisition.

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

• Not applicable. This is an MRI device for image acquisition, not a diagnostic algorithm. Its output ("images") is intended to be interpreted by a human physician.

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

• For the technical performance aspects, the "ground truth" is adherence to the specified engineering and imaging standards (e.g., NEMA, IEC).
• For the "sample clinical images," no formal ground truth establishment process for diagnostic purposes is described, as these were provided for qualitative "substantial equivalence" support, not quantitative diagnostic performance.

8. The sample size for the training set:

• Not applicable. This document describes an MRI system, not an AI algorithm requiring a training set for diagnostic performance.

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

• Not applicable as no training set for an AI algorithm is mentioned.

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