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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.

Ask a specific question about this device

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 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.

As previously described in K182036 and K222983, the NeuroBlate System is typically used for the ablation of target tissue (tumors, radiation necrosis, 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 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™. M-Vision Pro™. M-Vision Fusion™ , or Fusion-STM 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, MRI head coils, and other optional accessories, . including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.

There is no change to entire system, with the exception of an additional NB3 (1.6mm) Laser Probe and the corresponding labeling updates.

The provided text refers to the FDA's 510(k) premarket notification for the Monteris Medical NeuroBlate System, specifically concerning the addition of a new NB3 (1.6mm) Laser Probe. The document focuses on demonstrating substantial equivalence to existing predicate devices rather than detailing a study that proves the device meets specific acceptance criteria in the context of clinical performance or AI algorithm validation.

Therefore, many of the requested sections related to acceptance criteria, device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets do not apply to the information provided in this regulatory submission.

The document primarily describes:

• Device Description: The NeuroBlate System and the new NB3 probe.
• Intended Use/Indications for Use: What the device is intended to do (ablate, necrotize, or coagulate intracranial soft tissue) and its role in planning and monitoring thermal therapies under MRI visualization.
• Comparison to Predicate Devices: How the new NB3 probe is similar to previously cleared NeuroBlate probes and other competitive laser probes.
• Summary of Supporting Data: A high-level overview of the design verification and validation process, stating that acceptance criteria were defined and met.

Since this is a 510(k) submission for a modification (adding a new probe size) and relies on substantial equivalence, it does not present a clinical study with detailed performance metrics against specific acceptance criteria in the way an AI/ML device submission would.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements." And "Each validation protocol described the objective, test method and acceptance criteria. The corresponding test reports confirmed (and documented) the modified NeuroBlate System met the user needs and intended use."

However, the specific quantitative acceptance criteria and the reported numerical device performance results are NOT explicitly provided in the given text. The comparison table (Table 1: Substantial Equivalence; Technical Comparison) focuses on technical characteristics for demonstrating substantial equivalence, not performance against clinical acceptance criteria.

Based on the provided text, a table cannot be constructed with specific numerical acceptance criteria and reported device performance. The document only states that such criteria were met during design verification and validation.

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

Not applicable/Not provided. The document describes design verification and validation activities, but does not detail a specific "test set" in the context of a clinical performance study with patient data, nor does it mention sample sizes for such tests or data provenance. The focus is on technical equivalence and design control compliance.

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

Not applicable/Not provided. This information would typically be relevant for studies evaluating human interpretation or AI algorithm performance. The document focuses on the technical aspects of a medical device (laser probe) and its regulatory clearance based on substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Similar to the above, adjudication methods are associated with studies involving human interpretation or AI performance assessment, which is not the focus of this regulatory submission as presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This device is a surgical tool (laser probe) for thermal therapy, not an AI-assisted diagnostic or interpretative system that would typically be evaluated in an MRMC study concerning human reader improvement. While the NeuroBlate System "provides MRI-based trajectory planning assistance" and "near real-time thermographic analysis," it explicitly states, "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." The submission focuses on the new probe's physical properties and safety, not on the comparative effectiveness of an AI component.

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

Not applicable/Not provided. The NeuroBlate System's software (M-Vision, M-Vision Pro, M-Vision Fusion, Fusion-STM) is described as providing "near real-time thermographic analysis," but the submission does not detail a standalone performance evaluation of this analytic component. The overall regulatory focus is on the substantial equivalence of the physical laser probe and system.

7. The Type of Ground Truth Used

Not explicitly provided in detail. The document mentions that the design verification and validation process confirmed the device met "design input for the requirements" and "user needs and intended use." This implies a ground truth defined by engineering specifications and intended clinical outcomes, but the specific methodologies for establishing this ground truth (e.g., in vivo pathology, clinical outcomes as defined for a clinical trial) are not described in the given text.

8. The Sample Size for the Training Set

Not applicable/Not provided in the context of an AI/ML training set. The document describes the development and testing of a physical medical device (laser probe), not the training of an AI algorithm.

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

Not applicable/Not provided. As there is no mention of a training set for an AI/ML algorithm in the provided text, this question is not addressed.

Ask a specific question about this device

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 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.

As previously described in K201056. the NeuroBlate System is tvpically used for the minimally invasive ablation of target tissue (tumors, radiation necrosis, 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 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™, M-Vision Pro™, M-Vision ● Fusion™, or Fusion-STM 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, MRI head coils, and 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.

There is no change to entire system, with the exception of an additional NeuroBlate Fusion-STM Software Package (V3.17). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one intended change which modifies an existing risk control measure for a hazardous situation and thus, per FDA 510(k) guidance, requires a new 510(k) submission.

The provided document is a 510(k) summary for the Monteris Medical NeuroBlate System with Fusion-S Software V3.17. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, performance metrics, or detailed results of a study (like a clinical trial) that proves the device meets those criteria, as typically found in a comprehensive clinical study report.

The document refers to "design verification and design validation" and "performance testing" but only provides a high-level summary rather than concrete data.

Therefore, many of the requested details cannot be extracted from this document, and the response will reflect that.

Here's the information that can be extracted and what cannot:

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

The document states: "The Design Verification process utilized protocols to detail the associated tests. Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements." And "The performance of the V3.17 software was tested utilizing automated and manual test methods and was found to be comparable to that of predicate V3.16 software. All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics."

However, the specific "acceptance criteria" and "reported device performance" are not detailed in this summary. It only states that the performance was "within acceptable limits" and "comparable" to the predicate.

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

This information is not provided in the document. The document refers to "test methods" and "metrics" but does not specify the nature or origin of any data used for testing.

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)

This information is not provided in the document. While the system is intended to be "interpreted by a trained physician," there is no mention of experts establishing a ground truth for a test set.

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

This information is not provided in the document.

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

This information is not provided and is unlikely to be relevant. The NeuroBlate System is explicitly described as a "neurosurgical tool" and not an AI-driven diagnostic or interpretative system that assists human readers. While it provides "MRI-based trajectory planning assistance" and "near real-time thermographic analysis," these are functionalities of a surgical guidance system, not an AI to improve human reader performance in a diagnostic context. The document also states: "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." This further indicates its role as a tool rather than an independent diagnostic AI.

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

The document does not detail specific "standalone" performance metrics in the way a diagnostic AI would. The device, the NeuroBlate System, is a surgical tool with software for planning and monitoring. The software component (Fusion-S V3.17) is an integral part of this human-in-the-loop surgical system. Therefore, a "standalone algorithm only" performance study in the context of diagnostic AI is not applicable or described.

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

This information is not provided in the document. The document describes "design verification and design validation" but doesn't specify the ground truth for these tests.

8. The sample size for the training set

This information is not provided. The document describes software modifications and validation but does not mention a "training set" in the context of machine learning, suggesting that the software updates are likely traditional software engineering changes rather than a new AI model being trained.

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

This information is not provided and is likely not applicable given the nature of the software modification described (traditional software updates vs. AI model training).

Summary Table of What Could Be Extracted:

Study Proving Device Meets Acceptance Criteria:

The document briefly describes the study as "The updated Fusion-S (V3.17) Software development process followed Monteris' documented Quality System and incorporated a design verification and design validation process. This process included an overarching Design Verification and Design Validation Master Plan."

• Design Verification: "utilized protocols to detail the associated tests. Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements."
• Design Validation: "utilized protocols to detail the associated tests. Each validation protocol described the objective, test method and acceptance criteria. The corresponding test reports confirmed (and documented) the modified NeuroBlate System met the user needs and intended use."
• Performance Testing: "The performance of the V3.17 software was tested utilizing automated and manual test methods and was found to be comparable to that of predicate V3.16 software. All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics."

In essence, the study was a set of internal design verification and validation tests following the company's quality system, comparing the V3.17 software to its predicate V3.16 version. The specific details, raw data, or detailed methodologies are not included in this 510(k) summary.

Ask a specific question about this device

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 and epileptic 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 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 K171255, K182036, K193375, 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 (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, M-Vision Fusion, and Fusion-S 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 FDA 510(k) summary (K201056) for the NeuroBlate System does not contain a study that proves the device meets specific acceptance criteria in the manner one might expect for a stand-alone AI/software device evaluation.

Instead, this document describes a modification to the device's "Indications for Use" statement. The core argument for safety and effectiveness is based on the device's substantial equivalence to previously cleared predicate devices (K171255, K182036, K193375). The modifications are described as "minor (non-significant)" and intended to "improve clarity and ease of understanding."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a new study, nor details about sample sizes, expert qualifications, or adjudication methods for a test set, because such a study is not presented in this document.

Here's what can be extracted based on the provided text:

• No new study data for AI/software performance is presented in this 510(k) for the modifications. The document explicitly states: "As these modifications to the Indications For Use do not create a new intended use or raise new or different questions of safety or efficacy and incorporates previously provided clinical data(4), additional clinical data are not necessary to demonstrate substantial equivalence." Clinical data from previous submissions (which are incorporated by reference) formed the basis for the original clearances.

Let's address the specific points you asked for, in the context of what is available in this document:

1. A table of acceptance criteria and the reported device performance: This document does not present such a table because it's a submission for an IFU clarity update, not a new performance study. The performance of the NeuroBlate System was established in prior 510(k) clearances (K171255, K182036, K193375) through "in-vitro (bench) and in-vivo (animal) data." No specific numerical acceptance criteria or performance metrics are reported in this document.

2. Sample size used for the test set and the data provenance: Not applicable to this specific submission. The data provenance would refer to the previous clearances (K171255, K182036, K193375) which are not detailed here. The submission mentions "Real World Evidence from Monteris' on-going post-market registry" and "scientific clinical literature peer reviewed published data," but these are cited as justification for the clarity of the IFU rather than a new test set for the modifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this specific submission.

4. Adjudication method for the test set: Not applicable to this specific submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable to this specific submission. The device description of the NeuroBlate System as a "neurosurgical tool" that provides "near real-time thermographic analysis" and "information that may be useful in the determination or assessment of therapy" when "interpreted by a trained physician" indicates physician involvement. However, this document does not present an MRMC study comparing physician performance with and without the device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable to this specific submission. The device is explicitly designed for "interpretation by a trained physician" and patient management decisions "should not be made solely on the basis of the NeuroBlate System analysis."

7. The type of ground truth used: Not applicable to this specific submission. For the previous clearances, it would likely have involved histopathological confirmation for ablation efficacy in animal models and potentially post-treatment imaging or clinical outcomes for human studies (if any were submitted then).

8. The sample size for the training set: Not applicable to this specific submission. This document pertains to an IFU update, not a new algorithm development or re-training.

9. How the ground truth for the training set was established: Not applicable to this specific submission.

In summary: K201056 is a 510(k) submission primarily focused on clarifying the Indications For Use statement of an existing medical device (NeuroBlate System). It does not present new performance data, test sets, or studies comparing the device's performance against acceptance criteria in the context of a new or modified AI/software component, as its justification rests on substantial equivalence to prior FDA clearances. The performance and safety of the device were established in those earlier submissions, which are referenced but not detailed here.

Ask a specific question about this device

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.

As previously described in K182036 and K173305, 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:

• 0 Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone.
• 0 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™, M-Vision Pro™, or M-Vision ● Fusion™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsvstems.

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.

There is no change to entire system, with the exception of an additional NeuroBlate Fusion-STM Software Package (V3.15).

This FDA 510(k) summary for the Monteris Medical NeuroBlate™ System with the Fusion-S Software (V3.15) focuses on demonstrating substantial equivalence to a predicate device, primarily due to software modifications. It does not present a detailed study on device performance against specific acceptance criteria in the manner requested for an AI/ML device.

The document describes software development processes (design verification and validation) and states that these processes confirmed the device met user needs and intended use, but it does not provide specific performance metrics, sample sizes, or ground truth details common in AI/ML performance studies.

Therefore, I cannot extract the detailed information requested in the prompt based on the provided text, as the application's focus is on substantial equivalence rather than a new performance study with specific acceptance criteria for a novel AI/ML component.

Here's a breakdown of why the requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states that "Each verification test protocol incorporated clearly defined acceptance criteria" and "Each validation protocol described the objective, test method and acceptance criteria," but it does not list these criteria or the numerical results of meeting them.
2. Sample sizes used for the test set and the data provenance: This information is not provided. The document mentions "design verification and design validation process" but doesn't specify test set sizes or data origins.
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. Ground truth establishment is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a separate performance study. The device is described as assisting a "trained physician," indicating a human-in-the-loop context for its intended use, but no specific AI performance study is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: This refers to an AI/ML training set, which is not applicable or discussed here as this is a software modification rather than an AI/ML training process for a new algorithm.
9. How the ground truth for the training set was established: Not applicable, as detailed AI/ML training is not the subject of this 510(k).

In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of an updated version of an existing device (NeuroBlate System with Fusion-S software) to its predicates, rather than presenting a performance study for a novel AI/ML component against specific acceptance criteria. The modifications are described as "not change the intended use, operating principles, or raise any unaddressed safety concerns." The verification and validation processes mentioned are general quality system activities to ensure the software functions as intended and meets user needs, not a specific clinical performance study with the metrics and details requested for an AI/ML evaluation.

Ask a specific question about this device

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.

Ask a specific question about this device

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 intracranial delivery of precision thermal therapy in the practice of neurosurgery.

As previously described in K172881, 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 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™ 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) NeuroBlate M-Vision/ M-Vision Pro Software Package (V3.13). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one proposed change which modifies an existing risk control measure for a hazardous situation and thus, per FDA 510(k) guidance, requires a new 510(k) submission.

The provided text describes the Monteris Medical NeuroBlate™ System (K173305), which is a modification of a previously cleared device (K172881). The submission is for an updated M-Vision/M-Vision Pro Software Package (V3.13). The document primarily focuses on demonstrating substantial equivalence to the predicate device due to a software update that modifies an existing risk control measure.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Each verification test protocol incorporated clearly defined acceptance criteria" and "Each validation protocol described the objective, test method and acceptance criteria." However, it does not provide the specific acceptance criteria or the reported performance data for these tests. It only states that the tests "confirmed (and documented) the design output met the design input for the requirements" and that the "modified NeuroBlate™ System met the user needs and intended use."

To fill the table below, I must infer the general nature of the criteria based on the device and its intended use, as specific details are not provided. The device performs planning and real-time thermographic analysis for thermal therapy. Therefore, acceptance criteria would likely relate to the accuracy, precision, and reliability of these functions.

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

The document does not specify the sample size for the test set used in the design verification or design validation. It only mentions that "The Design Verification process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the design output met the design input for the requirements." Similarly, for validation, "The Design Validation process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the modified NeuroBlate™ System met the user needs and intended use."

The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. The indications for use state "When interpreted by a trained physician," implying that qualified medical professionals are involved in the use and interpretation of the system, but this doesn't directly address the establishment of ground truth for testing purposes.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The submission is for a software update to an existing device, focusing on maintaining substantial equivalence rather than a new clinical effectiveness claim through an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes software (M-Vision/M-Vision Pro) that provides "trajectory planning assistance" and "real-time thermographic analysis." It explicitly states, "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis," indicating that a human (trained physician) is always intended to be in the loop.

Therefore, it is highly likely that standalone algorithm-only performance was evaluated as part of the design verification (e.g., measuring the inherent accuracy of planning algorithms or thermographic calculations), but not as a replacement for human-in-the-loop performance in the clinical application. The document indicates that the software provides "information that may be useful" and requires interpretation by a trained physician.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for either verification or validation. Given the nature of a laser thermal therapy system, potential ground truths could include:

• Physical measurements/phantoms: For accuracy of laser delivery and thermal profile generation during verification.
• Pathology/histology: To confirm ablation zones in preclinical or bench testing.
• Expert consensus/clinical outcomes: To evaluate the system's utility and accuracy in real or simulated clinical scenarios during validation, although this is inferred.

The document states the purpose of the software update was for a "risk control measure for a hazardous situation," suggesting that the ground truth for evaluating this might involve risk analyses, simulated failure modes, and verification of corrective actions.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the submission concerns a software update (V3.13) for an existing system, and the description focuses on verification and validation of changes rather than the development of a new AI/ML model that typically involves distinct training sets.

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

As no training set is discussed or implied for a new AI/ML model, the establishment of ground truth for a training set is not applicable in this context. The V3.13 software is likely a deterministic software update rather than an adaptive AI system requiring a 'training set' in the machine learning sense.

Ask a specific question about this device

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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 K170724 and K171255, 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);
• 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) NeuroBlate System modified Laser Probe Umbilicals.

The provided text describes a 510(k) premarket notification for a modification to the Monteris Medical NeuroBlate™ System. The primary modification involves "an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals which incorporate a modified Thermocouple assembly manufacturing process and several umbilical related Strain Relief component updates."

Crucially, the document states that this submission involves no change to the indications for use, intended use, operating principles, or core technology of the NeuroBlate™ system. It asserts substantial equivalence to previous versions (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) based on design verification and validation of the modified umbilical components, not a study of the overall clinical performance of the device or its AI components (such as thermographic analysis).

Therefore, this document does not contain information about a study that measures device performance against acceptance criteria in the way typically expected for an AI/CADe device's clinical efficacy or standalone performance. The "acceptance criteria" discussed are related to engineering and design verification/validation of a modified component, not clinical outcomes or diagnostic accuracy.

Given this context, I cannot directly provide the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format you specified, as those types of studies (MRMC, standalone performance, expert ground truth for a test set) are not described for this specific submission. This is a component modification submission, not a new device or a new AI feature submission that would typically require such clinical performance studies.

However, I can extract the information that is present regarding the validation process for the modified umbilical:

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

The document mentions that "Each verification test protocol incorporated clearly defined acceptance criteria" for the design verification process, and "Each validation protocol described the objective, test method and acceptance criteria" for the design validation process concerning the modified Laser Probe Umbilicals. However, the specific acceptance criteria and the reported numeric performance results for these criteria are NOT provided in this document. It generally states that these processes confirmed the design output met design input requirements and that the modified system met user needs and intended use.

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

This information is not provided in the document. The testing described is design verification and validation of a medical device component (umbilicals), not a clinical study with patient data provenance.

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)

This information is not provided in the document. Ground truth as typically understood for clinical performance studies (e.g., expert consensus) is not mentioned because this submission focuses on component-level engineering validation.

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

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving human interpretation or uncertain diagnoses, which are not detailed here.

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 was not described in this document. This submission is for a modification to a component of an existing system, not a new AI-assisted diagnostic or therapeutic tool requiring such a comparative effectiveness study. The "real-time thermographic analysis" mentioned in the device's indications for use is part of the existing system, and this submission does not detail new studies on its performance or the effect size of AI assistance.

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

A standalone performance study of an algorithm was not described in this document for this submission.

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

This information is not provided in the document. The validation pertains to component functionality rather than clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

This information is not provided in the document. This submission describes component modification and validation, not the development or training of an AI algorithm with a training set.

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

This information is not provided in the document. No training set is mentioned as this device modification does not involve an AI model requiring a new training set.

Ask a specific question about this device

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.

Ask a specific question about this device

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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