(29 days)
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstital irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical NeuroBlate™ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate™ Laser Delivery Probes. It also provides real-time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis.
The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K143457 and K162762, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.
The NeuroBlate™ System components consist of:
- Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver . controlled energy to a target zone.
- . Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position, stabilize and manipulate a probe, endoscope or other device within the target zone.
- . An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- In consideration that the proposed change is an alternative (portable) Connector o Module (PCM) subcomponent, related Connector Module discussion topics are separated out from the overall Interface Platform (IP) description, discussion and comparison purposes.
- A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation,
- A Control Workstation including the M-Vision™ and M-Vision Pro™ software, which ● includes a user interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.
The NeuroBlate™ System is utilized with stereotaxic frames and patient stabilization systems, such as:
- . The Axiiis stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation components, and
- . The AtamA Stabilization System and MRI receive-only head coil, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools).
Thus, there is no change to entire system, with the exception of an additional (alternative) Portable Connector Module (PCM). The PCM provides the capability to be mounted in various positions on the Interface Platform (IP) Arms, utilizes an externalized laser fiber connector as well as alternative commercially available thermocouple cable connectors (i.e., connectors which utilize wires soldered to connector pins compared to the commercially available connectors which utilize wires crimped to connector pins).
The provided document is a 510(k) premarket notification for the Monteris Medical NeuroBlate™ System. It focuses on the substantial equivalence of a modified version of the system (with an alternative Portable Connector Module - PCM) to its predicate devices.
Crucially, this document does NOT contain the detailed acceptance criteria or the study results proving the device meets those criteria in the context of AI/algorithm performance.
The document discusses the regulatory approval process (510(k)), device description, indications for use, comparison to predicate device, and a summary of supporting data related to design verification and validation for the specific modification (PCM). It states that the PCM development followed Monteris' Quality System, including design verification and validation processes with defined acceptance criteria. However, it does not provide those specific acceptance criteria, nor does it detail studies related to the clinical performance of an AI/algorithm component (like sensitivity, specificity, accuracy, or human reader improvement with AI assistance).
The "M-Vision™ and M-Vision Pro™ software" are mentioned as including a user interface for procedure planning and interactive monitoring, but there's no information on them being an AI/algorithm that performs diagnostic or prognostic tasks that would require the kind of performance studies you're asking about. The software provides "real-time thermographic analysis of selected MRI images" and "information that may be useful in the determination or assessment of thermal therapy," explicitly stating that "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis." This suggests it's a tool providing raw data or analysis assistance, not an AI for automated diagnosis or a "human-in-the-loop" performance study in the way typically discussed for AI/ML diagnostic devices.
Therefore,Based on the provided text, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies because this information is not present. The document focuses on regulatory approval for hardware modifications to an existing system, not the performance validation of a new or modified AI/algorithm component.
§ 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.