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The Neuro III-SV Intra-operative MRI system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that displays the internal structure and / or function of the head and whole body. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Neuro III-SV may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.

The Neuro III-SV may also be used for imaging in a multi-room suite.

The Neuro III-SV system is a traditional MRI unit that has been suspended on an overhead rail system to facilitate intra-operative use. The main components of the Neuro III-SV system are the MRI system assembly (including diagnostic RF coils), the magnet mover system, the OR Table assembly, Head Fixation Device and the Intra-operative Coil.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Neuro III-SV Intra-operative Magnetic Resonance Imaging System in the format requested.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with detailed acceptance criteria and reported device performance.

Here's what can be extracted and what is explicitly missing based on your requested format:

What is Available in the Document:

• Device Name: Neuro III-SV Intra-operative Magnetic Resonance Imaging System
• Intended Use/Indications for Use: The system is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce images of the head and whole body for diagnosis, and for imaging during intra-operative and interventional procedures.
• Demonstration of Safety and Effectiveness: The document states that testing was completed to verify equivalence to the Siemens MAGNETOM Verio System and to verify safe and effective intra-operative operation. However, the details of this testing (acceptance criteria, specific performance metrics, sample sizes, ground truth, etc.) are not provided.
• Substantial Equivalence: The primary method of demonstrating safety and effectiveness is through substantial equivalence to:
  • Siemens MAGNETOM Verio 3T MRI System (for software, imaging related safety, and effectiveness issues like SNR, uniformity, geometric distortion, slice profile, spatial resolution).
  • IMRIS Neuro II-SE and Neuro II-S systems (for intra-operative features like the Magnet Mover Assembly, OR Patient Table, Intra-operative Coil, and Head Fixation Device).

Missing Information (Based on your request):

1. Table of Acceptance Criteria and Reported Device Performance: This is completely absent. The document states that testing was done to "verify equivalence" and "verify safe and effective intra-operative operation," but does not list specific measurable criteria or the results achieved.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is typically used for AI-assisted workflows to show improvement over unassisted human readers, which is not applicable here as the device itself is a diagnostic imaging system, not an AI-powered diagnostic aide.
6. Standalone (algorithm only without human-in-the loop performance) study: Not applicable in the context of an MRI system itself. Performance would be measured by image quality parameters and system functionality, not an "algorithm's" diagnostic accuracy without human interpretation.
7. The type of ground truth used: Not mentioned. For an MRI system, ground truth would typically relate to physical phantoms for image quality metrics, and clinical evaluations for operational safety and utility, but specifics are missing.
8. Sample size for the training set: Not applicable and not mentioned, as this is not an AI/ML device that requires a training set in the conventional sense. The "training" here would be for the development of the MRI system's hardware and software based on engineering principles and comparison to established MRI technology.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

Conclusion:

The provided document K083137 serves as a 510(k) summary for regulatory clearance, relying heavily on the concept of "substantial equivalence" to existing predicate devices. It states that testing was performed to verify safety and effectiveness, but it does not provide the detailed study information, including specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that you requested for an in-depth performance study. This is common for 510(k) submissions, where the detailed test reports are typically held by the manufacturer and not fully disclosed in the public summary.

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