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The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), 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 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 intended patients are adults and pediatric from the age of 2 years and older.

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.

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 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 text is an FDA 510(k) clearance letter for the Monteris Medical NeuroBlate System (K240877). This document primarily focuses on demonstrating substantial equivalence to a predicate device (K231061) and modifying the pediatric age range in the Indications for Use. It explicitly states that "no additional testing was required" because the changes are labeling-related and "no physical changes, manufacturing changes, process changes, materials changes, or technology changes" were made to the system.

Therefore, the document does not contain details about specific acceptance criteria, a study proving the device met those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies for this specific submission (K240877). The information provided heavily references data from the predicate device (K231061) and general clinical literature reviews.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as no new acceptance criteria or device performance data were generated for this specific submission (K240877). The submission focuses on a labeling change to an existing device, relying on previous data.

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

This information is not provided for this specific submission as no new testing was required. The document mentions that "adult and pediatric data from Monteris' prospective LAANTERN Registry was also reviewed," but it does not specify the sample size from this registry or explicitly define it as a "test set" for this submission. The provenance is from Monteris' prospective registry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided for this specific submission as no new testing was required.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided for this specific submission as no new testing was required.

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

An MRMC study is not mentioned for this specific submission. The NeuroBlate System is a physical laser thermal therapy system with software for planning and monitoring, not an AI diagnostic tool for interpreting images for human readers.

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

A standalone performance study is not mentioned for this specific submission. The device is intended to be used by a "trained physician" for planning and monitoring, with patient management decisions "not made solely on the basis of the NeuroBlate System analysis," indicating a human-in-the-loop system.

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

This information is not explicitly stated for any data underlying the predicate device, other than general references to "LITT related clinical literature" and "NeuroBlate System commercial clinical experience," and data from the "LAANTERN Registry" (which would likely include outcomes data).

8. The sample size for the training set

This information is not provided for this specific submission as no new technical development or training of algorithms is indicated; the submission relies on previously established performance of the predicate device.

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

This information is not provided for this specific submission as no new technical development or training of algorithms is indicated.

Summary of Change in K240877 and Rationale:

The core of this 510(k) submission (K240877) is a labeling change to the existing Monteris Medical NeuroBlate System (predicate K231061). The change is to explicitly include "pediatric patients from the age of 2 years and older" in the "Indications for Use" statement, clarifying an existing "adult and pediatric" intended patient population.

The submission asserts that because "no physical changes, manufacturing changes, process changes, materials changes, or technology changes" were made to the device, and the "technical modes of action and technical principles remain the same," no additional testing (in-vitro or in-vivo) was required. The conclusion that the device remains safe and effective for this expanded age range is based on:

• Review of LITT related clinical literature.
• Review of Monteris' own NeuroBlate System commercial clinical experience.
• Review of adult and pediatric data from Monteris' prospective LAANTERN Registry.

The document explicitly states: "Monteris has concluded from these reviews that the NeuroBlate LITT system has been, and remains, an effective and safe tool for use in pediatric patients." This serves as the "study" for this submission, validating the labeling change rather than a new device performance study. However, specific details about the methods or data from these reviews are not included in this FDA letter.

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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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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 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:

• A gas-cooled Laser Delivery Probe (Probe) 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 adds a line of Diffusing Tip Laser Delivery Probes (DTP) to the existing line of Side-Firing Laser Delivery Probes.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. The document focuses on showing substantial equivalence of a new diffusing tip probe to an existing side-firing probe, rather than detailing a rigorous clinical trial with specific performance metrics against an acceptance threshold.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of human data or a sample size for such a set. The studies mentioned are primarily "bench and animal testing."

• Test Set Sample Size: Not specified for human data; applied to "bench and animal testing."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The data appears to be from internal company testing (bench and animal studies).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The study relies on bench and animal testing, not a ground truth established by human experts for a specific test set of cases. The device's information is to be "interpreted by a trained physician," but this refers to its clinical use, not the validation study itself.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as the study design does not involve human readers evaluating a test set of cases that would require 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (laser delivery probes), not an AI-assisted diagnostic tool for human readers.

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

This is not directly applicable in the context of this device. The NeuroBlate System, while having software for planning and monitoring, is a physical medical device (laser delivery probe) used by a physician. Its performance is intrinsically tied to human-in-the-loop operation. The "standalone" performance here refers to the physical and functional performance of the device itself (e.g., ablation capabilities confirmed through bench and animal testing), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance (specifically, its ability to ablate, necrotize, or coagulate soft tissue and its compliance with expectations) was established through:

• Bench Testing: Laboratory evaluations of the device's physical and functional properties.
• Animal Testing: In-vivo studies on animals to assess the device's effects on tissue.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a medical device (hardware and associated software for control), not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm mentioned in this document.

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