(185 days)
The Monteris Medical UFO™ is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.
The Monteris Medical UFO™ (Universal Frameless platform for neur() surgical applications) is designed to facilitate stereotactic targeting and positioning of various neurosurgical devices through a burr hole in the patient's skull. These devices could include laser probes, biopsy needles, electrodes and catheters.
The UFO is comprised of three telescoping legs connected to a center ball joint. Each of the legs can be attached to the patient's skull with two MR1-compatible titanium bone screws. By adjusting the height of each leg, and the axis of the rotatable center ball, various trajectories can be obtained for the guide that runs through the center ball. UFO is MRI compatible
Multiple center ball adapters are available to interface with the center ball guide tube. These adapters reduce the guide tube diamcter down to an inner diameter that is compatible with the outer diameter of the tools that the user may want to place through the UFQ. The adapter for a specific tool ensures the tool remains lined up along the intended axis of the UFO.
Several accessories are provided with the UFO to improve its utility during the preparation for stereotactic neurological procedures. They are all made of MRI compatible materials only.
All devices are single use only and ethylene oxide sterilized.
This document is a 510(k) Premarket Notification for the Monteris Medical UFO™ (Universal Frameless platform for neurosurgical applications) system. As such, it reports the device's substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial report would.
Based on the provided text, here’s a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a performance table in the format usually found in a clinical study report. Instead, it relies on demonstrating substantial equivalence to predicate devices (Navigus Trajectory Guide and Navigus II Trajectory Guide).
The "performance" is generally described as:
| Category | Reported Device Performance |
|---|---|
| Biocompatibility | In compliance with ISO 10993 |
| Bench Testing | In compliance with the product specification, expectations of the medical community, and product labeling |
| Intended Use | Substantially equivalent in intended use to predicate devices |
| Technology | Substantially equivalent in technology to predicate devices |
| Design | Substantially equivalent in design to predicate devices |
| Materials | Substantially equivalent in materials to predicate devices |
| Physician Use | Substantially equivalent in physician use to predicate devices |
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 makes no mention of a "test set" in the context of clinical performance or accuracy testing involving patients or expert review of outputs. The studies reported are bench testing and biocompatibility analysis. Therefore, information on sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable to this submission as described.
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 "test set" for clinical performance described in the provided text, there is no information on the number of experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given no described "test set" for clinical performance, there is no information on an adjudication method.
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 Monteris Medical UFO™ is a stereotaxic instrument guide, not an AI or imaging diagnostic device that would typically involve a multi-reader multi-case (MRMC) study. The document does not mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical instrument for surgical guidance, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" would be the engineering specifications and expected physical performance parameters for the device (e.g., mechanical stability, accuracy of trajectory guidance relative to a target). For biocompatibility, the ground truth is adherence to ISO 10993 standards. No clinical ground truth (like pathology or outcomes data from patients) is mentioned.
8. The sample size for the training set
The document does not describe any machine learning or AI components, so the concept of a "training set" with a sample size is not applicable.
9. How the ground truth for the training set was established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).