(168 days)
The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), 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 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 K201056. the NeuroBlate System is tvpically used for the minimally invasive ablation of target tissue (tumors, radiation necrosis, epileptic foci) in the brain.
The NeuroBlate System components consist of:
- Families of gas-cooled Laser Delivery 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 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™, M-Vision ● Fusion™, or Fusion-STM 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 Monteris Cranial Bolt and Mini-Bolt fixation components, and
- The AtamA Stabilization System, MRI head coils, and 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 (V3.17). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one intended change which modifies an existing risk control measure for a hazardous situation and thus, per FDA 510(k) guidance, requires a new 510(k) submission.
The provided document is a 510(k) summary for the Monteris Medical NeuroBlate System with Fusion-S Software V3.17. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, performance metrics, or detailed results of a study (like a clinical trial) that proves the device meets those criteria, as typically found in a comprehensive clinical study report.
The document refers to "design verification and design validation" and "performance testing" but only provides a high-level summary rather than concrete data.
Therefore, many of the requested details cannot be extracted from this document, and the response will reflect that.
Here's the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The Design Verification process utilized protocols to detail the associated tests. Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements." And "The performance of the V3.17 software was tested utilizing automated and manual test methods and was found to be comparable to that of predicate V3.16 software. All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics."
However, the specific "acceptance criteria" and "reported device performance" are not detailed in this summary. It only states that the performance was "within acceptable limits" and "comparable" to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "test methods" and "metrics" but does not specify the nature or origin of any data used for testing.
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. While the system is intended to be "interpreted by a trained physician," there is no mention of experts establishing a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided and is unlikely to be relevant. The NeuroBlate System is explicitly described as a "neurosurgical tool" and not an AI-driven diagnostic or interpretative system that assists human readers. While it provides "MRI-based trajectory planning assistance" and "near real-time thermographic analysis," these are functionalities of a surgical guidance system, not an AI to improve human reader performance in a diagnostic context. The document also states: "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." This further indicates its role as a tool rather than an independent diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not detail specific "standalone" performance metrics in the way a diagnostic AI would. The device, the NeuroBlate System, is a surgical tool with software for planning and monitoring. The software component (Fusion-S V3.17) is an integral part of this human-in-the-loop surgical system. Therefore, a "standalone algorithm only" performance study in the context of diagnostic AI is not applicable or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. The document describes "design verification and design validation" but doesn't specify the ground truth for these tests.
8. The sample size for the training set
This information is not provided. The document describes software modifications and validation but does not mention a "training set" in the context of machine learning, suggesting that the software updates are likely traditional software engineering changes rather than a new AI model being trained.
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable given the nature of the software modification described (traditional software updates vs. AI model training).
Summary Table of What Could Be Extracted:
| Category | Detail Provided in Document |
|---|---|
| Acceptance Criteria & Performance | Acceptance Criteria: "Each verification test protocol incorporated clearly defined acceptance criteria." Reported Performance: "All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics." (Specific criteria and metrics are NOT detailed.) The performance was "found to be comparable to that of predicate V3.16 software." |
| Test Set Sample Size & Provenance | Not provided. |
| Experts for Ground Truth | Not provided. |
| Adjudication Method | Not provided. |
| MRMC Comparative Effectiveness | Not performed/not applicable for this type of surgical guidance system. The device is a "neurosurgical tool" providing "planning and monitoring" and "thermographic analysis" under MRI. Patient management decisions should not be made solely on its analysis. |
| Standalone Performance | The device is a human-in-the-loop surgical system not a standalone diagnostic algorithm. No standalone performance study (in the context of AI diagnostics) is described. |
| Type of Ground Truth | Not specified. |
| Training Set Sample Size | Not provided; likely not applicable as the software update appears to be traditional software engineering rather than AI model training. |
| Training Set Ground Truth | Not provided; likely not applicable. |
Study Proving Device Meets Acceptance Criteria:
The document briefly describes the study as "The updated Fusion-S (V3.17) Software development process followed Monteris' documented Quality System and incorporated a design verification and design validation process. This process included an overarching Design Verification and Design Validation Master Plan."
- Design Verification: "utilized protocols to detail the associated tests. Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements."
- Design Validation: "utilized protocols to detail the associated tests. Each validation protocol described the objective, test method and acceptance criteria. The corresponding test reports confirmed (and documented) the modified NeuroBlate System met the user needs and intended use."
- Performance Testing: "The performance of the V3.17 software was tested utilizing automated and manual test methods and was found to be comparable to that of predicate V3.16 software. All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics."
In essence, the study was a set of internal design verification and validation tests following the company's quality system, comparing the V3.17 software to its predicate V3.16 version. The specific details, raw data, or detailed methodologies are not included in this 510(k) summary.
§ 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.