(29 days)
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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.
As previously described in K170724 and K171255, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.
The NeuroBlate™ System components consist of:
- Families of gas-cooled Laser Delivery Probe (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 Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- A System Electronics Rack and Components, which includes necessary umbilicals, . cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation,
- A Control Workstation including the M-Vision™ and M-Vision Pro™ 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 Axiiis stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation . components, and
- The AtamA Stabilization System and MRI receive-only head coil, as well as, 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).
Thus, there is no change to entire system, with the exception of an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals.
The provided text describes a 510(k) premarket notification for a modification to the Monteris Medical NeuroBlate™ System. The primary modification involves "an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals which incorporate a modified Thermocouple assembly manufacturing process and several umbilical related Strain Relief component updates."
Crucially, the document states that this submission involves no change to the indications for use, intended use, operating principles, or core technology of the NeuroBlate™ system. It asserts substantial equivalence to previous versions (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) based on design verification and validation of the modified umbilical components, not a study of the overall clinical performance of the device or its AI components (such as thermographic analysis).
Therefore, this document does not contain information about a study that measures device performance against acceptance criteria in the way typically expected for an AI/CADe device's clinical efficacy or standalone performance. The "acceptance criteria" discussed are related to engineering and design verification/validation of a modified component, not clinical outcomes or diagnostic accuracy.
Given this context, I cannot directly provide the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format you specified, as those types of studies (MRMC, standalone performance, expert ground truth for a test set) are not described for this specific submission. This is a component modification submission, not a new device or a new AI feature submission that would typically require such clinical performance studies.
However, I can extract the information that is present regarding the validation process for the modified umbilical:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Each verification test protocol incorporated clearly defined acceptance criteria" for the design verification process, and "Each validation protocol described the objective, test method and acceptance criteria" for the design validation process concerning the modified Laser Probe Umbilicals. However, the specific acceptance criteria and the reported numeric performance results for these criteria are NOT provided in this document. It generally states that these processes confirmed the design output met design input requirements and that the modified system met user needs and intended use.
2. Sample sized 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 testing described is design verification and validation of a medical device component (umbilicals), not a clinical study with patient data provenance.
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. Ground truth as typically understood for clinical performance studies (e.g., expert consensus) is not mentioned because this submission focuses on component-level engineering validation.
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 involving human interpretation or uncertain diagnoses, which are not detailed 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
An MRMC study was not described in this document. This submission is for a modification to a component of an existing system, not a new AI-assisted diagnostic or therapeutic tool requiring such a comparative effectiveness study. The "real-time thermographic analysis" mentioned in the device's indications for use is part of the existing system, and this submission does not detail new studies on its performance or the effect size of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not described in this document for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The validation pertains to component functionality rather than clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
This information is not provided in the document. This submission describes component modification and validation, not the development or training of an AI algorithm with a training set.
9. How the ground truth for the training set was established
This information is not provided in the document. No training set is mentioned as this device modification does not involve an AI model requiring a new training set.
§ 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.