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The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstital 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 NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.

As previously described in K143457 and K162762, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.

The NeuroBlate™ System components consist of:

• Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver . controlled energy to a target zone.
• . Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position, stabilize and manipulate a probe, endoscope or other device within the target zone.
• . An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
  • In consideration that the proposed change is an alternative (portable) Connector o Module (PCM) subcomponent, related Connector Module discussion topics are separated out from the overall Interface Platform (IP) description, discussion and comparison purposes.
• A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation,
• A Control Workstation including the M-Vision™ and M-Vision Pro™ software, which ● includes a user interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.

The NeuroBlate™ System is utilized with stereotaxic frames and patient stabilization systems, such as:

• . The Axiiis stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation components, and
• . The AtamA Stabilization System and MRI receive-only head coil, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools).

Thus, there is no change to entire system, with the exception of an additional (alternative) Portable Connector Module (PCM). The PCM provides the capability to be mounted in various positions on the Interface Platform (IP) Arms, utilizes an externalized laser fiber connector as well as alternative commercially available thermocouple cable connectors (i.e., connectors which utilize wires soldered to connector pins compared to the commercially available connectors which utilize wires crimped to connector pins).

The provided document is a 510(k) premarket notification for the Monteris Medical NeuroBlate™ System. It focuses on the substantial equivalence of a modified version of the system (with an alternative Portable Connector Module - PCM) to its predicate devices.

Crucially, this document does NOT contain the detailed acceptance criteria or the study results proving the device meets those criteria in the context of AI/algorithm performance.

The document discusses the regulatory approval process (510(k)), device description, indications for use, comparison to predicate device, and a summary of supporting data related to design verification and validation for the specific modification (PCM). It states that the PCM development followed Monteris' Quality System, including design verification and validation processes with defined acceptance criteria. However, it does not provide those specific acceptance criteria, nor does it detail studies related to the clinical performance of an AI/algorithm component (like sensitivity, specificity, accuracy, or human reader improvement with AI assistance).

The "M-Vision™ and M-Vision Pro™ software" are mentioned as including a user interface for procedure planning and interactive monitoring, but there's no information on them being an AI/algorithm that performs diagnostic or prognostic tasks that would require the kind of performance studies you're asking about. The software provides "real-time thermographic analysis of selected MRI images" and "information that may be useful in the determination or assessment of thermal therapy," explicitly stating that "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis." This suggests it's a tool providing raw data or analysis assistance, not an AI for automated diagnosis or a "human-in-the-loop" performance study in the way typically discussed for AI/ML diagnostic devices.

Therefore,Based on the provided text, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies because this information is not present. The document focuses on regulatory approval for hardware modifications to an existing system, not the performance validation of a new or modified AI/algorithm component.

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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 NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.

As previously described in K143457, the NeuroBlate System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.

The NeuroBlate System components consist of:

• Families of gas-cooled Laser Delivery Probe (SideFire & FullFire) to deliver controlled energy to a target zone.
• Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position, stabilize and manipulate a probe, endoscope or other device within the target zone.
• An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Advanced and Robotic Probe Drivers and interconnections for the Laser Delivery Probes;
• A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation.
• A Control Workstation including the M-Vision™ and M-Vision Pro™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate procedures, and interfaces to the MRI and hardware subsystems.

The NeuroBlate System is utilized with stereotaxic frames and patient stabilization systems, such as:

• The Axiiis stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation components, and
• The AtamA Stabilization System and MRI receive-only head coil, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, bone screws, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.

The provided document is a 510(k) premarket notification for the Monteris Medical NeuroBlate™ System. It states that no new performance data or studies were required for this specific submission because the changes are limited to labeling modifications and corrections, primarily due to a Class 1 Recall and FDA 483 observations, and do not involve physical, manufacturing, process, materials, or technology changes to the device itself.

Therefore, most of the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this particular 510(k) submission. The document explicitly states: "Considering the proposed changes are labeling related, the previously provided in-vitro (bench) data remains applicable and no additional bench testing was required."

However, I can extract the relevant information regarding the device and the nature of this submission:

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

Since this submission did not involve new performance studies, specific acceptance criteria for new performance tests are not detailed. The submission focuses on compliance with regulatory requirements for labeling.

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

Not applicable to this submission as no new performance studies (and thus no new test sets) were conducted. The submission relies on previously conducted studies for the predicate device.

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 to this submission as no new performance studies were conducted. Clinical interpretation by a "trained physician" is mentioned in the Indications for Use for assessing thermal therapy, but this pertains to clinical use, not a specific study for this submission.

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

Not applicable to this submission as no new performance studies were conducted.

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

Not applicable. The NeuroBlate System is a thermal therapy device with software for planning and monitoring, not an AI diagnostic tool for which MRMC comparative effectiveness studies with human readers would typically be performed in this context. The document indicates physician interpretation, but not in the context of an MRMC study for this submission.

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

The device's software provides "real time thermographic analysis" and "MRI based trajectory planning assistance." The "Indications for Use" explicitly states: "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." This indicates a human-in-the-loop design where the software provides information to a physician, rather than acting as a standalone diagnostic algorithm. No new standalone performance study (algorithm-only) was reported for this submission.

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

Not applicable to this submission as no new performance studies were conducted. For the underlying efficacy and safety of the thermal ablation, ground truth in previous studies would likely have involved histopathology or clinical outcomes, but this is not detailed in the provided document for this specific filing.

8. The sample size for the training set

Not applicable to this submission as no new performance studies were conducted. If the system incorporates machine learning components (which is not explicitly detailed but might be part of "thermographic analysis"), any training data would have been from prior development phases and not detailed in this specific labeling-focused submission.

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

Not applicable to this submission as no new performance studies were conducted.

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