(78 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 collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.
The NeuroBlate System components consist of:
- . Families of gas-cooled Laser Delivery Probes (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone. This application includes the smaller diameter SideFire Select and FullFire Select families of Probes;
- 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;
- 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 NeuroBlateTM procedures, and interfaces to the MRI and hardware subsystems.
This submission adds a line of 2.2mm Reduced Diameter Probes to the existing 3.3mm diameter probes. They will be known as the SideFire Select™ and FullFire Select™ Probes.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Monteris Medical NeuroBlate™ System (K143457):
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive de novo clinical study with detailed performance metrics and ground truth establishment. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, and standalone performance metrics) is not explicitly available in this type of document.
The document primarily relies on bench testing to demonstrate that the new, smaller diameter probes function equivalently to the previously cleared larger diameter probes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from bench testing) |
|---|---|
| Electrical Requirements | New Laser Delivery Probes exhibited compliance to the same electrical requirements as predicate sizes. |
| Mechanical Integrity and Operation (e.g., Cooling) | New Laser Delivery Probes exhibited compliance to the same mechanical integrity and operation (e.g., cooling) requirements as predicate sizes. |
| Laser Emission Requirements | New Laser Delivery Probes exhibited compliance to the same laser emission requirements as predicate sizes. |
| Interface with NeuroBlate System | New Laser Delivery Probes interfaced with the NeuroBlate System in an identical manner to predicate sizes. |
| Adequate Labeling for Accurate Placement | Adequate labeling information was provided to ensure accurate placement within the target tissue. |
| Laser Emission Patterns and Ablation Effect | The application System with the Reduced Diameter Laser Delivery Probes has similar laser emission patterns and laser ablation effect as the predicate Laser Delivery Probes. |
| Overall Performance Equivalence to Predicate | The NeuroBlate system works as well with the Reduced Diameter Probe as it does with the larger diameter versions. |
| Compliance with Medical Community Expectations | The device is in compliance with the medical community's expectations and product labeling and specifications. |
Note: The document states that the new probes are "compliant to the same electrical requirements" or "exhibited compliance to the same electrical requirements" etc. It does not provide the specific numerical values or thresholds for these requirements, but rather asserts that the new device meets whatever those pre-established requirements were for the predicate device.
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not specified. The testing described is bench testing, not a clinical trial with a defined patient test set.
- Data Provenance: Bench testing data, implies in-house laboratory testing. No country of origin for data specifically is mentioned, but the manufacturer is Monteris Medical Corp. located in Plymouth, MN, USA. The testing is retrospective in the sense that it evaluates a modified device against established performance characteristics of the predicate. It is not prospective clinical data.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Not applicable as the study described is primarily bench testing comparing a modified device to a predicate, not clinical performance requiring expert ground truth for interpretation.
- The indications for use state: "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." This indicates that the system is intended to be used by trained physicians, but this is not part of the ground truth establishment for the reported bench tests.
4. Adjudication Method (Test Set)
- Not applicable, as the study described is bench testing and does not involve human interpretation or adjudication in the context of clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned or indicated in the document. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical and functional characteristics. The "AI vs without AI assistance" aspect is not relevant here as the device is a laser thermal therapy system, not an AI diagnostic algorithm.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- The document implies standalone performance through the bench testing described, where the device components (probes, interface, workstation) are tested for their individual and integrated functions. However, "standalone" in the context of AI algorithms typically refers to the algorithm's diagnostic performance without human input. This device is a surgical instrument and monitoring system, meaning its performance by nature is intertwined with human use (e.g., a "trained physician" interpreting thermographic analysis for patient management decisions). Thus, a pure "algorithm only" standalone performance comparison is not directly applicable in the same way it would be for an AI diagnostic tool.
7. Type of Ground Truth Used
- For the bench testing, the "ground truth" implicitly refers to the established specifications and performance characteristics of the predicate device, against which the modified probes were compared. This would include measurable physical properties (e.g., laser power, cooling efficiency), mechanical tolerances, and interface compatibilities. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
- Not applicable. The document describes bench testing for substantial equivalence, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a "training set" in the context of AI algorithm development.
§ 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.