(66 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 thermal 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 adds a line of Diffusing Tip Laser Delivery Probes (DTP) to the existing line of Side-Firing Laser Delivery Probes.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. The document focuses on showing substantial equivalence of a new diffusing tip probe to an existing side-firing probe, rather than detailing a rigorous clinical trial with specific performance metrics against an acceptance threshold.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Threshold/Standard) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Device is in compliance with the medical community's expectations and product labeling. | Bench testing demonstrated that the System (including the Diffusing-Tip Probe) is in compliance with the medical community's expectations and the product labeling. It "demonstrates that NeuroBlate system works as well with the Diffusing-Tip Probe as it does with the Side-Firing Probe." Additionally, animal testing was performed. The application "does not change the intended use, operating principles, or raise any unaddressed safety concerns" compared to the predicate device. |
| Performance - Ablation | Not explicitly stated as a numerical criterion; implied performance is that the Diffusing-Tip Laser Delivery Probes (DTP) create ablation lesions. | The application system with the Diffusing-Tip Laser Delivery Probe can create larger ablation lesion volumes during laser firing than the predicate Side-Firing Probe. |
| Substantial Equivalence | Device is substantially equivalent to the predicate device in intended use, technology, design, and physician use, and does not raise any new questions of safety or effectiveness. | The application Monteris Medical NeuroBlate™ System with the Side-Firing and Diffusing Tip Laser Delivery Probes is substantially equivalent to the predicate Monteris NeuroBlate™ System with only the Side-Firing Laser Delivery Probes in intended use, technology, design and physician use. The Indications for Use and fundamental technology are unchanged. All patient contacting materials are identical. Technical modes of action and principles are materially the same. Modifications do not change intended use, operating principles, or raise unaddressed safety concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human data or a sample size for such a set. The studies mentioned are primarily "bench and animal testing."
- Test Set Sample Size: Not specified for human data; applied to "bench and animal testing."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The data appears to be from internal company testing (bench and animal studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The study relies on bench and animal testing, not a ground truth established by human experts for a specific test set of cases. The device's information is to be "interpreted by a trained physician," but this refers to its clinical use, not the validation study itself.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as the study design does not involve human readers evaluating a test set of cases that would require adjudication.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (laser delivery probes), not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not directly applicable in the context of this device. The NeuroBlate System, while having software for planning and monitoring, is a physical medical device (laser delivery probe) used by a physician. Its performance is intrinsically tied to human-in-the-loop operation. The "standalone" performance here refers to the physical and functional performance of the device itself (e.g., ablation capabilities confirmed through bench and animal testing), not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance (specifically, its ability to ablate, necrotize, or coagulate soft tissue and its compliance with expectations) was established through:
- Bench Testing: Laboratory evaluations of the device's physical and functional properties.
- Animal Testing: In-vivo studies on animals to assess the device's effects on tissue.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a medical device (hardware and associated software for control), not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm mentioned in this document.
§ 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.