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The Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery for wavelengths of 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Thermoguide Therapy System can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

The Thermoguide Therapy System is compatible with 1.5T and 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device 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 analysis using the Thermoguide Therapy System

The Thermoguide Therapy System consists of the following three components:

1. Mobile Laser Unit
2. Laser applicator and introducer
3. Thermoguide Workstation

The Thermoguide Therapy System can be used for soft tissue laser ablation procedures by appropriate trained medical professionals only. The Thermoguide Therapy System has received FDA clearance for use with 3T magnetic resonance (MR) scanners (K214125). This submission expands the approval to include both 3T and 1.5T MR field strengths.

The system consists of a medical laser apparatus (Mobile Laser Unit), single use sterile devices (Laser applicator and introducer) and a workstation with software (Thermoguide Workstation) for extracting temperature maps from magnetic resonance (MR) images to calculate thermal dose in the tissue.

The Thermoguide Therapy System can be used for soft tissue laser ablation procedures using MR image guidance in minimal invasive procedures under local or general anesthesia. The system is optimized with advanced functions to control and monitor tissue temperatures within the ablation volume and surrounding tissue.

The Mobile Laser Unit is provided with a laser generator operating at the wavelength of 1064 nm, continuous wave. The generated laser light is locally applied by means of a single use applicator kit (Laser applicator and introducer) through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature that necrotizes or coagulates soft tissue.

The Laser applicator is a 12 m long optical fiber allowing the laser generator to be placed in the MRI control room. The treatment is monitored using the Thermoguide Workstation to measure temperature changes and estimate thermal damage resulting from the induced temperature increase.

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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 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.

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