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510(k) Data Aggregation
(28 days)
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the following stereotactic frames:
- 1 the Leksell Type G comprising of head frame and CT Localizer,
- 2 the CRW HRAIM with the BRWLF localizer.
- 3 the CRW UCHRA with the Luminant and BRWLF localizers
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This document is a 510(k) clearance letter for the neuromate Gen III device, a stereotaxic instrument. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily covers:
- The FDA's determination of substantial equivalence.
- Regulatory information regarding the device's classification, general controls, and compliance requirements.
- Instructions for reporting adverse events and seeking regulatory guidance.
- The device's Indications for Use, which describes its purpose (stereotactic spatial positioning and orientation of an instrument holder or tool guide for neurosurgical instruments) and the stereotactic frames it has been validated with.
Therefore, I cannot provide the requested information based on this document. The document confirms market clearance but does not detail the specific performance studies or acceptance criteria that led to that clearance.
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(90 days)
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).
A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
The provided text is a 510(k) Pre-market Notification for the neuromate Gen III device. It details the device's technical characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not include information about AI/ML models, multi-reader multi-case (MRMC) comparative effectiveness studies, or the types of clinical studies typically associated with proving the performance of AI-powered diagnostic devices.
The "study" referenced in the document is a performance validation of the mechanical accuracy of the stereotactic system, rather than an AI model.
Therefore, for your request, I will explain why many of the requested fields cannot be filled based on this document and address the parts that can be inferred.
This device (neuromate Gen III) is a stereotactic instrument, not an AI or imaging diagnostic device. The "validation" studies described relate to the mechanical accuracy and software performance of the medical device itself, not to the performance of an AI model in interpreting medical images or assisting human readers.
Acceptance Criteria and Device Performance (Based on "Performance Validation" of the Mechanical System)
The document describes "Performance Validation" of the neuromate Gen III system, focusing on its accuracy in the context of stereotactic surgery. This is about the mechanical accuracy of the robot.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy of the system for stereotactic positioning. | "The accuracy of the system complies with its claimed performances." |
| Equivalence in performance to the predicate system (K132755). | "is equivalent to those of the predicate system." |
| Specific Accuracy Claim (from Table comparison with predicate) | In Frame-based mode: |
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