(33 days)
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.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence | |
| Intended Use | Met (Identical) |
| Technology | Met (Materially the same) |
| Design | Met (Materially the same) |
| Physician Use | Met (Identical) |
| Patient Contacting Materials | Met (Identical in composition, source, and use) |
| Technical Modes of Action | Met (Materially the same) |
| Technical Principles | Met (Materially the same) |
| Operating Principles | Met (No change) |
| Safety Concerns | Met (No unaddressed safety concerns) |
| MRI Compatibility | |
| With GE 1.5T MRI systems | Demonstrated (Works as well as with Siemens and IMRIS MRIs) |
| With GE 3.0T MRI systems | Demonstrated (Works as well as with Siemens and IMRIS MRIs) |
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.
§ 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.