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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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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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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 Espree MRI System (including diagnostic coils), the Magnet Mover System, the OR Table Assembly and the Intra-operative Coil Kit.

The provided text is a 510(k) Summary of Safety and Effectiveness for the IMRIS Neuro II-SE Intra-Operative Magnetic Resonance Imaging System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain the information required to populate the provided table or answer the specific questions about acceptance criteria and study details.

Here's a breakdown of why the information is missing:

• Type of Document: A 510(k) summary focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. It typically avoids detailed performance studies with acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it relies on comparisons to the established safety and effectiveness of the predicate.
• Nature of the Device: The Neuro II-SE is an MRI system. Its "performance" refers to image quality metrics (signal to noise, uniformity, geometric distortion, etc.) and safety aspects (magnetic field effects, RF heating, acoustic noise), which are generally established through engineering and physical bench testing against industry standards or predicate device specifications, not typically through clinical performance studies involving human readers and ground truth as described in your prompt.
• Lack of AI/Algorithm: The Neuro II-SE is a hardware device for imaging, not an AI, algorithm, or software-as-a-medical-device (SaMD) that would have performance metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.

Therefore, I cannot extract the requested information from the provided text. The document states:

• "Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operation of the Neuro II-SE."
• "The Neuro II-SE does not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating or acoustic noise or effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution."

These statements indicate that specific tests were performed, but the details of those tests, including specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment, are not included in this summary.

In summary, based on the provided text, I cannot complete the table or answer the questions as they pertain to a different type of device validation study than what is presented here.

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The IMRIS Neuro II-S MRI system is indicated for use for the whole body. The Neuro II-S 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-S 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 IMRIS Neuro II-S Intra-operative MRI system is a traditional 1.5T MRI system that has been suspended from an overhead gantry to facilitate intra-operative use. The main components of the Neuro II-S system are the MRI system assembly ( including diagnostic RF coils), the magnet mover assembly, the OR patient table assembly and the intra-operative RF coil.

The provided text is a 510(k) summary for the IMRIS Neuro II-S Intra-operative Magnetic Resonance Imaging System, focusing on its substantial equivalence to previously marketed devices. It describes the device's technical specifications and indications for use. However, this document does not contain an "acceptance criteria and study that proves the device meets the acceptance criteria" as typically expected for demonstrating clinical performance or diagnostic accuracy.

The provided document describes a substantial equivalence determination process, where the new device (Neuro II-S) is compared to legally marketed predicate devices primarily based on design, intended use, and safety/effectiveness considerations. The "study" mentioned is laboratory testing to verify equivalence to the Siemens Magnetom Symphony System and to verify safe and effective intra-operative operation. This is a technical performance verification rather than a clinical study evaluating diagnostic performance against specific acceptance criteria.

Therefore, many of the requested information points, especially those related to clinical performance, expert ground truth, and statistical significance, are not applicable or not present in this type of regulatory submission.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

1. A table of acceptance criteria and the reported device performance

Note: This table reflects the nature of a 510(k) submission, which often relies on demonstrating substantial equivalence rather than defining and meeting specific quantitative clinical performance acceptance criteria through prospective clinical trials. The "performance" here is largely an assertion of equivalence and absence of new issues, supported by laboratory testing.

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

• Sample Size for Test Set: Not specified. The document mentions "laboratory testing" for verification but does not detail the size or nature of any "test set" in the context of clinical images or patient data.
• Data Provenance: Not specified.

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)

• Number of Experts: Not applicable. The document does not describe the establishment of ground truth by experts for a clinical test set. The evaluation focuses on technical equivalence and safety/effectiveness, not diagnostic accuracy.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No clinical test set requiring expert adjudication 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

• MRMC Study: No. The document does not describe an MRMC study. This device is an imaging system, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. The Neuro II-S is an MRI system, which produces images for interpretation by a trained physician. It is not an autonomous algorithm.

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

• Type of Ground Truth: Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the substantial equivalence claim is effectively the performance and safety characteristics of the predicate devices and the results of laboratory testing validating the new device's technical specifications.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As an MRI system, the Neuro II-S is not an AI algorithm that undergoes a "training" process with a dataset in the typical machine learning sense.

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

• Ground Truth Establishment for Training Set: Not applicable (see point 8).

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Ask a specific question about this device