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The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.
The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:

1. correspond to the distribution of protons exhibiting MR characteristics;
2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and
3. display the soft tissue structure of the body.
   When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
   The Neuro II-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
   The Neuro II-SE may also be used in a multi-room suite.

The Neuro II-SE 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 II-SE system are the MRI system assembly (including diagnostic RF coils), the magnet mover assembly, the OR Table assembly, Head Fixation Device and the Intra-operative Coil.

The provided text describes the 510(k) summary for the IMRIS Neuro II-SE Intra-operative Imaging System. However, it does not contain specific acceptance criteria tables nor detailed study results with performance metrics that directly address all the requested points.

The submission focuses primarily on establishing substantial equivalence to predicate devices rather than providing a detailed clinical performance study with defined acceptance criteria and statistical analysis as one might expect for a new algorithmic device today.

Here's a breakdown of the information that is available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria seem to be implicitly defined by "substantially equivalent" performance to predicate devices (IMRIS Neuro II-SE, Neuro II-S, and Siemens Magnetom Espree 1.5T MRI System) across various MRI imaging parameters.
• Reported Device Performance: The document states that "Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operative operation of the Neuro II-SE." However, no quantitative performance metrics (e.g., SNR values, image uniformity measures, spatial resolution results) from this laboratory testing are reported.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The "laboratory testing" mentioned is not detailed enough to determine a sample size for a test set.
• Data Provenance: Not specified. It's implied that the testing was laboratory-based, but no information on country of origin or whether it was retrospective/prospective is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified. The document states that images "When interpreted by a trained physician, ... yield information that can be useful in the determination of a diagnosis." This refers to the intended use of the images produced, not to a specific ground truth establishment process for a performance study.
• Qualifications of Experts: Not specified beyond "trained physician."

4. Adjudication Method for the Test Set

• Not specified. There is no mention of an adjudication process for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done according to this document. The focus is on device equivalence, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, in spirit, a standalone performance assessment was done, but not for an "algorithm" in the modern sense. The "device" itself (the MRI system) was assessed for its imaging capabilities in a standalone manner against the imaging characteristics of predicate devices. However, this is not an AI algorithm, but a hardware/software system. The document states: "The Neuro II-SE's (OR-DR-OR/OR-MB configurations) MRI imaging system's software and hardware are substantially equivalent to the Siemens Magnetom Espree 1.5T MRI System. ...effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution." This implies a technical, quantitative assessment of the raw imaging output, which is a form of standalone performance. No detailed results are provided.

7. Type of Ground Truth Used

• Technical Specifications / Predicate Device Performance: The "ground truth" for the equivalence assessment appears to be the established technical performance specifications and image quality characteristics of the predicate devices (Siemens Magnetom Espree, IMRIS Neuro II-SE, and Neuro II-S). The Neuro II-SE was tested to confirm it met similar performance benchmarks in a laboratory setting. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for a diagnostic performance study.

8. Sample Size for the Training Set

• Not Applicable / Not Specified. This device is an MRI imaging system, not an AI algorithm trained on a dataset of images in the contemporary sense. Therefore, there is no "training set" for an AI model.

9. How Ground Truth for the Training Set Was Established

• Not Applicable / Not Specified. As above, there is no training set mentioned.

Summary of Device Performance (from the document, not a table):

The Neuro II-SE Intra-operative Imaging System was deemed "substantially equivalent" to its predicate devices (IMRIS Neuro II-SE, Neuro II-S, and Siemens Magnetom Espree 1.5T MRI System) based on:

• Design and Intra-operative Features: Equivalent to predicate Neuro II-SE and Neuro II-S.
• MRI Imaging System Software and Hardware: Substantially equivalent to Siemens Magnetom Espree 1.5T MRI System regarding safety (static magnetic field effects, changing magnetic field effects, RF heating, acoustic noise) and effectiveness (specification volume, signal to noise, image uniformity, geometric distortion, slice profile, thickness and gap, high contrast spatial resolution).
• Laboratory Testing: Conducted to verify equivalence for MRI System (to Siemens Magnetom Espree) and safe and effective intra-operative operation.

The document does not provide specific numerical values or a direct breakdown of how the Neuro II-SE performed against specific numerical acceptance criteria (e.g., "SNR must be > X dB"). Instead, it relies on the concept of substantial equivalence to already cleared devices.

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