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The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.

The Monteris Medical NeuroBlate™ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate™ Laser Delivery Probes. It also provides real time thermographic analysis of selected MRI images.

When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis.

The Monteris Medical NeuroBlate™ System is a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy. The NeuroBlate System components consist of:

• . Gas-cooled Laser Delivery Probes (Probes) to deliver controlled energy to a target zone;
• A Probe Driver which allows the surgeon to precisely position, stabilize and . manipulate a laser probe within the target zone;
• . A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation; and
• A Control Workstation including the M Vision™ Software, which includes a user . interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.

This submission clears the use of the NeuroBlate System with specific 1.5 & 3.0T Philips Magnetic Resonance Imaging Systems.

The provided text describes the Monteris Medical NeuroBlate™ System, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document details regulatory information related to the 510(k) premarket notification process for the NeuroBlate System, specifically its compatibility with additional MRI systems (Philips). The "Summary of Supporting Data" section briefly mentions "Software and bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling" and that it "works as well with the Philips MRI's as it does with the Siemens, IMRIS, and GE MRI's." This is a general statement and does not provide quantified acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
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. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device described is a laser thermal therapy system, not an AI-assisted diagnostic tool, so an MRMC study in that context would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and generally not applicable for a device of this type which is an instrument used by a physician.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of extending compatibility with additional MRI systems, rather than presenting detailed performance efficacy data typically associated with studies proving device meets acceptance criteria related to accuracy or other clinical metrics for a diagnostic or AI-driven device.

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