(29 days)
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through internal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical NeuroBlate™ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate™ Laser Delivery Probes. It also provides near real-time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis.
The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided intracranial delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K182036 and K173305, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.
The NeuroBlate™ System components consist of:
- 0 Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone.
- 0 Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position. stabilize and manipulate a probe, endoscope or other device within the target zone.
- An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- . A System Electronics Rack and Components, which includes the laser and necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation,
- A Control Workstation including the M-Vision™, M-Vision Pro™, or M-Vision ● Fusion™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsvstems.
The NeuroBlate™ System is utilized with stereotaxic frames and patient stabilization systems, such as:
- The Axiiis stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation components, and
- The AtamA Stabilization System and MRI receive-only head coil, as well as other ● optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.
There is no change to entire system, with the exception of an additional NeuroBlate Fusion-STM Software Package (V3.15).
This FDA 510(k) summary for the Monteris Medical NeuroBlate™ System with the Fusion-S Software (V3.15) focuses on demonstrating substantial equivalence to a predicate device, primarily due to software modifications. It does not present a detailed study on device performance against specific acceptance criteria in the manner requested for an AI/ML device.
The document describes software development processes (design verification and validation) and states that these processes confirmed the device met user needs and intended use, but it does not provide specific performance metrics, sample sizes, or ground truth details common in AI/ML performance studies.
Therefore, I cannot extract the detailed information requested in the prompt based on the provided text, as the application's focus is on substantial equivalence rather than a new performance study with specific acceptance criteria for a novel AI/ML component.
Here's a breakdown of why the requested information cannot be provided from this document:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states that "Each verification test protocol incorporated clearly defined acceptance criteria" and "Each validation protocol described the objective, test method and acceptance criteria," but it does not list these criteria or the numerical results of meeting them.
- Sample sizes used for the test set and the data provenance: This information is not provided. The document mentions "design verification and design validation process" but doesn't specify test set sizes or data origins.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Ground truth establishment is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a separate performance study. The device is described as assisting a "trained physician," indicating a human-in-the-loop context for its intended use, but no specific AI performance study is detailed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: This refers to an AI/ML training set, which is not applicable or discussed here as this is a software modification rather than an AI/ML training process for a new algorithm.
- How the ground truth for the training set was established: Not applicable, as detailed AI/ML training is not the subject of this 510(k).
In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of an updated version of an existing device (NeuroBlate System with Fusion-S software) to its predicates, rather than presenting a performance study for a novel AI/ML component against specific acceptance criteria. The modifications are described as "not change the intended use, operating principles, or raise any unaddressed safety concerns." The verification and validation processes mentioned are general quality system activities to ensure the software functions as intended and meets user needs, not a specific clinical performance study with the metrics and details requested for an AI/ML evaluation.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.