(402 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 Probe. 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 document describes a 510(k) premarket notification for the Monteris Medical NeuroBlate™ System. The submission aims to demonstrate substantial equivalence to a predicate device, the Monteris AutoLITT® System, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not include explicit acceptance criteria with quantitative performance metrics for the device's clinical efficacy or safety, as would be expected for a study demonstrating clinical performance against predefined thresholds. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing and compatibility assessments.
Therefore, a table of acceptance criteria and reported device performance directly related to clinical outcomes cannot be constructed from this document.
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 bench testing for aspects like electromagnetic compatibility, MRI compatibility, and probe placement accuracy. There is no mention of a "test set" in the context of patient data for clinical performance evaluation. The data provenance and sample size for such a clinical test set are therefore not applicable here.
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)
Since there is no patient-based test set described for clinical performance, there is no information provided on experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given the lack of a patient-based test set for clinical performance, no adjudication method is mentioned or applicable.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The NeuroBlate™ System is a medical device for laser thermal therapy, not an AI-assisted diagnostic tool that would typically involve a multi-reader study of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The NeuroBlate™ System is a physical device used by a physician. While it includes "M Vision™ Software" for planning and monitoring, the document doesn't describe a "standalone algorithm only" performance study in the context of AI or diagnostic interpretation. Its "standalone" function is as a laser thermal therapy system with integrated monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing described, the "ground truth" would be engineering specifications and established physical principles (e.g., actual probe placement, measured electromagnetic interference, temperature changes during RF heating, ASTM standards for MR compatibility). There is no mention of ground truth related to clinical outcomes, pathology, or expert consensus in the context of clinical efficacy for the device.
8. The sample size for the training set
Since this is a 510(k) submission focused on substantial equivalence through bench testing, there is no mention of a "training set" for an algorithm in the machine learning sense. The device is not presented as a machine learning system that requires a training set of data.
9. How the ground truth for the training set was established
As there is no mention of a training set, the method for establishing its ground truth is not applicable.
In summary:
The provided document, a 510(k) summary, demonstrates the substantial equivalence of the NeuroBlate™ System to a predicate device primarily through bench testing and adherence to engineering and regulatory standards (e.g., IEC, ASTM). It does not present a clinical study with detailed acceptance criteria, performance metrics, and patient data analysis as typically seen for novel clinical efficacy claims or AI/diagnostic device approvals. The focus is on verifying the device's functionality, safety (e.g., MRI compatibility, EMC), and that modifications from the predicate do not alter its intended use or raise new safety concerns.
§ 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.