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The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through internal 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 near 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 intracranial delivery of precision thermal therapy in the practice of neurosurgery.

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 Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
• A System Electronics Rack and Components, which includes the laser and 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™ FUSION™ 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, 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).

This submission's proposed change simply replaces the Probe's existing internal metallic (wire) thermocouple with a non-metallic fiber optic. temperature sensor. The optical fiber temperature sensor has the identical function as the existing metallic (wire) thermocouple, i.e., to measure the probe tip's internal temperature and to transmit the temperature measurement to the NeuroBlate System and associated M-Vision Software.

Corresponding hardware and software changes are proposed in order to incorporate the new optical fiber component, e.g., (hardware) modified Connector Module, a Signal Conditioner (converts optical fiber signal to electrical temperature signal), and (software) M-Vision Pro Software Package (V3.14), along with associated labeling updates.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monteris Medical NeuroBlate™ System with the fiber optic temperature sensor.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the level of detail regarding specific acceptance criteria and study results, particularly for standalone performance or comparative effectiveness, is less comprehensive than what might be found in a full clinical study report.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for device performance in a table format. Instead, it broadly states that:

"The Design Verification process utilized protocols to detail the associated tests which confirmed the design output met the design input for the requirements. Each verification test protocol incorporated clearly defined acceptance criteria."

And for validation:

"The Design Validation process utilized protocols to detail the associated tests which confirmed the modified NeuroBlate™ System met the user needs and intended use. Each validation protocol described the objective, test method and acceptance criteria."

The core purpose of this submission is to demonstrate that the functionality of the new fiber optic temperature sensor (FOTS) is identical to the existing metallic (wire) thermocouple in measuring the probe tip's internal temperature and transmitting the data to the NeuroBlate System and M-Vision Software. The key performance aspect is that the FOTS prevents MRI induced unintentional Probe heating, which was the root cause of a recall (Z-0194-2018).

Given this, the "acceptance criteria" can be inferred as ensuring the new FOTS system performs as reliably and accurately as the previous system, while also actively eliminating the MRI-induced heating issue. Without specific protocols, a table of acceptance criteria and reported device performance cannot be generated with numerical values from this text. The reported device performance is that the new FOTS system successfully prevents the MRI induced unintentional Probe heating by eliminating the coupling of MR energy to the probe umbilical.

Detailed Information on the Study:

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

   • As explained above, explicit numerical acceptance criteria are not provided in this 510(k) summary. The primary criteria would revolve around the accurate and reliable measurement of probe tip internal temperature, and the successful prevention of MRI-induced heating. The reported performance is that the new FOTS system achieves this by addressing the root cause of the previous recall.

2. Sample size used for the test set and the data provenance

   • The document describes "design verification and design validation processes" but does not specify sample sizes for these tests.
   • Data provenance: Not explicitly stated, but given it's a medical device for intracranial use, the testing would generally be conducted in controlled laboratory or simulated environments, primarily in the US (where Monteris Medical is based). The study is retrospective in the sense that it's a modification to an existing device in response to a recall, and testing would validate the new design. It is not a clinical study on patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • This information is not provided. The ground truth for device performance in this context would likely be established through engineering measurement standards, calibration against established temperature reference standards, and MRI compatibility testing protocols. These would involve engineers and technical experts in fields like laser physics, MRI compatibility, and materials science, rather than medical experts for ground truth establishment for this specific modification.

4. Adjudication method for the test set

   • Adjudication methods (like 2+1, 3+1) are typically used for interpreting human-derived data like imaging reads. This scenario involves technical performance testing of a physical and software modification. Therefore, an adjudication method in this sense is not applicable and not mentioned.

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

   • No, an MRMC comparative effectiveness study was not done. This submission is for a modification to a laser ablation system's internal temperature sensor, not for an AI-assisted diagnostic tool. The device's primary function (laser ablation) and the interpretation of thermographic analysis by physicians remain unchanged.

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

   • The core modification is the replacement of a physical temperature sensor (thermocouple with Fiber Optic Temperature Sensor - FOTS) and associated hardware/software changes. The performance of the FOTS itself, in terms of accurate temperature measurement and signal transmission to the system's software, would have been tested in a standalone capacity (i.e., the sensor's accuracy and behavior independent of a human operator, but within the device system) as part of the "Design Verification" process. The document does not provide details on these specific tests or results.

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

   • The ground truth for the temperature sensor's performance would be based on physical measurement standards. This would involve:
     • Calibration against known temperature references.
     • Evaluation of the sensor's accuracy and precision according to established engineering and metrology standards.
     • Validation that the sensor effectively measures the probe tip's internal temperature and that the system controls cooling appropriately.
     • Crucially, validation that the FOTS does not interact adversely with MRI fields (the root cause of the recall), which would involve specialized MRI compatibility testing.

8. The sample size for the training set

   • This is not applicable. This device is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense. The software modifications are to integrate the new sensor signal, not to train an algorithm using data.

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

   • This is not applicable as there is no training set mentioned or implied for a machine learning model. The software changes are integration and adaptation for the new sensor's signal.

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The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through internal 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 that is currently indicated for the practice of neurosurgery.

As previously described in K162762, K170724, the NeuroBlate System is typically used for the minimally invasive ablation of neurosurgeon identified 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;
• . 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.

This is a 510(k) premarket notification for Monteris Medical NeuroBlate System, and the submission focuses on clarifying the indications for use statement rather than demonstrating the performance of a new or significantly modified device. Therefore, the typical structure for reporting acceptance criteria and study results for device performance does not apply to this document in the way it would for a new device or a major change.

Here's why and what can be extracted:

• No new device performance data: The document explicitly states: "Given that the modifications to the indications for use do not create a new intended use or raise new or different questions of safety or efficacy, clinical data are not necessary to demonstrate substantial equivalence." and "Considering the proposed changes are labeling clarifications, the previously provided in-vitro (bench), and in-vivo (animal) data remains applicable, and are incorporated by reference." This means no new studies were conducted for this specific submission to demonstrate the device meets acceptance criteria for performance; rather, the existing demonstrated performance of the predicate device is relied upon.

However, I can extract information related to the purpose of this submission and the basis for claiming substantial equivalence given the proposed changes:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a labeling clarification and not a new device or significant performance change, there are no new defined acceptance criteria for device performance presented here, nor new reported device performance metrics. The "acceptance criteria" in this context are regulatory in nature: that the clarified indications do not alter the intended use or raise new safety/effectiveness questions.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable (no new testing)
• Data Provenance: Not applicable (no new testing). The previous "in-vitro (bench), and in-vivo (animal) data" mentioned are "incorporated by reference" from prior submissions (K162762, K170724), implying no new data was generated for the current filing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This submission doesn't involve establishing ground truth for a test set of data as it's a labeling clarification.

4. Adjudication method for the test set

• Not applicable. This submission doesn't involve a test set requiring adjudication.

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. This device is not an AI/CADe system in the context of diagnostic image interpretation, and no MRMC study was conducted or referenced for this submission. The device is a "Magnetic Resonance Image Guided Laser Thermal Therapy System" that provides "real-time thermographic analysis of selected MRI images" primarily for planning and monitoring thermal therapies.

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

• Not applicable. The device provides "information that may be useful in the determination or assessment of thermal therapy" and explicitly states: "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." This indicates it's an assistive tool, not a standalone diagnostic or therapeutic algorithm, and no standalone performance study was done for this particular submission.

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

• Not applicable for this submission as no new performance data was generated. For the predicate devices, "in-vitro (bench), and in-vivo (animal) data" were used, which would typically rely on established physical measurements and anatomical/histological verification relevant to laser ablation efficacy and safety.

8. The sample size for the training set

• Not applicable. This submission is not about an algorithm that requires a training set.

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

• Not applicable.

In summary, this 510(k) notification is a regulatory update to previously cleared devices (K162762, K170724) concerning the clarity of its "indications for use" statement. It asserts that these changes do not impact the device's technical characteristics, intended use, or fundamental safety and effectiveness, thus negating the need for new performance studies or data. The basis for substantial equivalence relies on the existing substantial equivalence determinations for the predicate devices and the argument that the proposed labeling changes are purely clarificatory.

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