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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 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.

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