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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 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 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 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 interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.

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

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

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

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

The NeuroBlate System components consist of:

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

The device's software provides "real time thermographic analysis" and "MRI based trajectory planning assistance." The "Indications for Use" explicitly states: "When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis." This indicates a human-in-the-loop design where the software provides information to a physician, rather than acting as a standalone diagnostic algorithm. No new standalone performance study (algorithm-only) was reported for this submission.

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

The NeuroBlate System components consist of:

• . Families of gas-cooled Laser Delivery Probes (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone. This application includes the smaller diameter SideFire Select and FullFire Select families of Probes;
• 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;
• 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 NeuroBlateTM procedures, and interfaces to the MRI and hardware subsystems.

This submission adds a line of 2.2mm Reduced Diameter Probes to the existing 3.3mm diameter probes. They will be known as the SideFire Select™ and FullFire Select™ Probes.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Monteris Medical NeuroBlate™ System (K143457):

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive de novo clinical study with detailed performance metrics and ground truth establishment. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, and standalone performance metrics) is not explicitly available in this type of document.

The document primarily relies on bench testing to demonstrate that the new, smaller diameter probes function equivalently to the previously cleared larger diameter probes.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the new probes are "compliant to the same electrical requirements" or "exhibited compliance to the same electrical requirements" etc. It does not provide the specific numerical values or thresholds for these requirements, but rather asserts that the new device meets whatever those pre-established requirements were for the predicate device.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not specified. The testing described is bench testing, not a clinical trial with a defined patient test set.
• Data Provenance: Bench testing data, implies in-house laboratory testing. No country of origin for data specifically is mentioned, but the manufacturer is Monteris Medical Corp. located in Plymouth, MN, USA. The testing is retrospective in the sense that it evaluates a modified device against established performance characteristics of the predicate. It is not prospective clinical data.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Not applicable as the study described is primarily bench testing comparing a modified device to a predicate, not clinical performance requiring expert ground truth for interpretation.
• The indications for use state: "When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis." This indicates that the system is intended to be used by trained physicians, but this is not part of the ground truth establishment for the reported bench tests.

4. Adjudication Method (Test Set)

• Not applicable, as the study described is bench testing and does not involve human interpretation or adjudication in the context of clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study is not mentioned or indicated in the document. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical and functional characteristics. The "AI vs without AI assistance" aspect is not relevant here as the device is a laser thermal therapy system, not an AI diagnostic algorithm.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• The document implies standalone performance through the bench testing described, where the device components (probes, interface, workstation) are tested for their individual and integrated functions. However, "standalone" in the context of AI algorithms typically refers to the algorithm's diagnostic performance without human input. This device is a surgical instrument and monitoring system, meaning its performance by nature is intertwined with human use (e.g., a "trained physician" interpreting thermographic analysis for patient management decisions). Thus, a pure "algorithm only" standalone performance comparison is not directly applicable in the same way it would be for an AI diagnostic tool.

7. Type of Ground Truth Used

• For the bench testing, the "ground truth" implicitly refers to the established specifications and performance characteristics of the predicate device, against which the modified probes were compared. This would include measurable physical properties (e.g., laser power, cooling efficiency), mechanical tolerances, and interface compatibilities. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• Not applicable. The document describes bench testing for substantial equivalence, not the development or training of an AI algorithm.

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

• Not applicable, as there is no mention of a "training set" in the context of AI algorithm development.

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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 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 clears the use of the NeuroBlate System with specific 1.5 & 3.0T General Electric Magnetic Resonance Imaging Systems.

The provided document, K131955, describes the Monteris Medical NeuroBlate™ System and its substantial equivalence to a predicate device. This submission specifically addresses the compatibility of the NeuroBlate System with General Electric (GE) MRI systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:

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

The provided document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics of the device itself. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device, specifically regarding compatibility with additional MRI systems.

The core acceptance criterion is that the modified device (NeuroBlate™ System compatible with GE MRI) is substantially equivalent to the predicate device (NeuroBlate™ System compatible with Siemens and IMRIS MRI) in terms of:

• Intended use
• Technology
• Design
• Physician use
• Patient contacting materials
• Technical modes of action and technical principles
• No change in operating principles or unaddressed safety concerns.

The reported device performance is that it meets this substantial equivalence.

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

The document primarily describes a bench testing and software testing approach to demonstrate compatibility.

• Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the context of patient data or specific device units tested. It refers to "bench testing" and "software testing," which typically involve testing under controlled laboratory conditions rather than with human subjects.
• Data Provenance: Not applicable in the context of clinical data. The testing described is "bench testing" and "software testing," which are laboratory-based studies to verify device functionality and compatibility. There is no mention of country of origin for such data.
• Retrospective or Prospective: Not applicable as the testing described is not a clinical study involving patients.

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. The study described focuses on technical compatibility and substantial equivalence, not on clinical performance assessed by experts. The statement "When interpreted by a trained physician, this System provides information that may be useful..." refers to the intended use of the device, not the validation of its compatibility with GE MRIs.

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 where expert consensus is needed to establish ground truth for ambiguous cases, which is not the type of study described 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

No such MRMC comparative effectiveness study is mentioned or implied in the provided text. The device is a "Magnetic Resonance Image Guided Laser Thermal Therapy System," not described as an AI-powered diagnostic or assistive tool for human readers in the context of this submission. The submission is focused on MRI compatibility validation.

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

The document mentions "software and bench testing" demonstrating compliance. This implies standalone testing of the software and hardware components (algorithm only for software, device performance for bench testing) to ensure functionality and compatibility. However, it does not detail specific algorithm-only performance metrics or studies in isolation from the overall system and its intended use. The "thermographic analysis" and "trajectory planning assistance" provided by the software are functionalities of the system, which would have been tested in a standalone manner during software testing.

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

For the compatibility study, the "ground truth" would be established by technical specifications, engineering standards, and successful demonstration of the device's functionality and safety when integrated with GE MRI systems. This would involve:

• Bench Test Results: Direct measurements and observations of device performance (e.g., laser energy delivery, probe positioning accuracy, temperature monitoring) within the MRI environment.
• Software Test Results: Verification that the M Vision™ Software performs its functions (procedure planning, interactive monitoring, thermographic analysis) correctly and integrates properly with the GE MRI interface.
• MRI Artifact Assessment: Ensuring the device does not produce unacceptable artifacts in the MRI images.
• Safety Standards Compliance: Adherence to relevant safety standards for medical devices and MRI compatibility.

Therefore, the ground truth is based on technical validation against specifications and safety standards rather than expert consensus on clinical cases or pathology outcomes.

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms. While the system's software provides "thermographic analysis" and "trajectory planning assistance," there is no indication that it utilizes a "training set" in the sense of supervised machine learning for its primary function in this submission. The focus is on the device's physical and software compatibility with new MRI machines.

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

Not applicable, as no "training set" in the context of machine learning is mentioned for this submission.

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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.

Ask a specific question about this device

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 Probe. 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 document describes a 510(k) premarket notification for the Monteris Medical NeuroBlate™ System. The submission aims to demonstrate substantial equivalence to a predicate device, the Monteris AutoLITT® System, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

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

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

The provided text does not include explicit acceptance criteria with quantitative performance metrics for the device's clinical efficacy or safety, as would be expected for a study demonstrating clinical performance against predefined thresholds. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing and compatibility assessments.

Therefore, a table of acceptance criteria and reported device performance directly related to clinical outcomes cannot be constructed from this document.

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

The document primarily describes bench testing for aspects like electromagnetic compatibility, MRI compatibility, and probe placement accuracy. There is no mention of a "test set" in the context of patient data for clinical performance evaluation. The data provenance and sample size for such a clinical test set are therefore not applicable here.

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)

Since there is no patient-based test set described for clinical performance, there is no information provided on experts establishing ground truth for such a set.

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

Given the lack of a patient-based test set for clinical performance, no adjudication method is mentioned or applicable.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The NeuroBlate™ System is a medical device for laser thermal therapy, not an AI-assisted diagnostic tool that would typically involve a multi-reader study of diagnostic interpretation.

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

This question is not directly applicable. The NeuroBlate™ System is a physical device used by a physician. While it includes "M Vision™ Software" for planning and monitoring, the document doesn't describe a "standalone algorithm only" performance study in the context of AI or diagnostic interpretation. Its "standalone" function is as a laser thermal therapy system with integrated monitoring.

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

For the bench testing described, the "ground truth" would be engineering specifications and established physical principles (e.g., actual probe placement, measured electromagnetic interference, temperature changes during RF heating, ASTM standards for MR compatibility). There is no mention of ground truth related to clinical outcomes, pathology, or expert consensus in the context of clinical efficacy for the device.

8. The sample size for the training set

Since this is a 510(k) submission focused on substantial equivalence through bench testing, there is no mention of a "training set" for an algorithm in the machine learning sense. The device is not presented as a machine learning system that requires a training set of data.

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

As there is no mention of a training set, the method for establishing its ground truth is not applicable.

In summary:

The provided document, a 510(k) summary, demonstrates the substantial equivalence of the NeuroBlate™ System to a predicate device primarily through bench testing and adherence to engineering and regulatory standards (e.g., IEC, ASTM). It does not present a clinical study with detailed acceptance criteria, performance metrics, and patient data analysis as typically seen for novel clinical efficacy claims or AI/diagnostic device approvals. The focus is on verifying the device's functionality, safety (e.g., MRI compatibility, EMC), and that modifications from the predicate do not alter its intended use or raise new safety concerns.

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The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging. The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The Monteris medical AtamA™ System is comprised of two major subsystems: (i) a MR head coil functionality, and (ii) a patient stabilization functionality. These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. The Head Coil Subsystem is comprised of a novel design of a standard split-array multichannel (8 channel) receive coil in the form of a common Lower Coil and two interchangeable Upper Coils (only one used at any time) and the appropriate coil configuration data, known as "coil files", for the selected MR system to be used. The design of the two-part Head Coil system is such that, in conjunction with the rest of the AtamA System, openings in the two-part coil can be rotated around the patient's head to allow surgical access to essentially any supratentorial aspect of the patient's head, and still allow for the collection of MR data without repositioning the patient or moving the coils within the MR system. This will allow for more expedient collection of high quality MR data, minimize moving the patient, and maintenance of spatial registration (required for or supporting stereotactic procedures). The Stabilization subsystem is comprised of three major components and their accessories. The major components are: A Head Fixation Ring (HFR) apparatus, A Cradle that fixates the HFR and the two-part Coil relative to each other and the MRI system bore, and A patient Board that allows for the effective transport of the patient to and from various procedures and procedure locations while maintaining the stability and spatial registration of the patient.

The provided document describes a medical device, the Monteris Medical AtamA™ System, and its substantial equivalence to predicate devices, rather than a study proving the device meets a specific set of acceptance criteria based on clinical performance metrics. The document explicitly states: "This application does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence to the stated predicate devices."

Therefore, I cannot provide information for many of the requested categories related to clinical performance studies. However, I can extract information regarding non-clinical performance and the device's characteristics.

Here’s a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics in the way one would expect for a clinical performance study (e.g., sensitivity, specificity, accuracy). Instead, it states:

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

Not applicable, as no clinical performance study with a test set was mentioned or conducted. The non-clinical performance data appears to be from bench testing and biocompatibility assessments, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical performance study with a test set was mentioned or conducted.

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

Not applicable, as no clinical performance study with a test set was mentioned or conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a head coil and stabilization system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable, as this is a hardware device, not an algorithm.

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

For the non-clinical performance, the "ground truth" or reference points were:

• ISO 10993 for biocompatibility.
• Product specifications, expectations of the medical community, and product labeling for bench testing.
• Recognized standards (NEMA Magnetic Resonance Imaging standards) and actual/reported values of predicate devices for coil functionality.

8. The sample size for the training set

Not applicable, as no training set for an algorithm was mentioned or used.

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

Not applicable, as no training set for an algorithm was mentioned or used.

Summary of the study conducted (as per the document):

The document explicitly states that the application for the Monteris Medical AtamA™ System does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence. Instead, the substantial equivalence to predicate devices is supported by:

• Non-Clinical Performance Data:
  • Biocompatibility analysis: Demonstrated compliance with ISO 10993.
  • Bench testing: Demonstrated compliance with product specifications, the expectations of the medical community, and product labeling.
  • Performance testing for Coil functionality: Conducted according to recognized standards (NEMA Magnetic Resonance Imaging standards, where appropriate) and by comparing to actual or reported values of predicate devices.
• Technological Characteristics: The device's technical modes of action and technical principles are materially the same as the predicate devices, including split array 8-channel MR head coil design, construction, functionally similar materials, and the same principles of head stabilization/immobilization. The design differences are in integration and utilization for expediency and convenience.

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