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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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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.

Explanation for Missing Information:

For the following points, the information is not present in the provided document because the device is a mechanical stereotactic system and not an AI-based diagnostic device where such information would typically be collected.

2. Sample size used for the test set and the data provenance: Not applicable. The "performance validation" here refers to testing the mechanical and functional accuracy of the device, not an AI model on a dataset of patient scans. The document mentions validation "with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer)," implying a physical setup for testing accuracy rather than a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device's accuracy is established through engineering measurements and metrology, not expert review of images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device does not involve AI assistance for human readers in image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm being evaluated for standalone performance. The device is a surgical robot guided by a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance validation of this device would be precise mechanical measurements and engineering specifications for positioning accuracy, not medical diagnoses or pathology reports.

8. The sample size for the training set: Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a stereotactic surgical instrument, which is a mechanical robot used in neurosurgery. While it discusses software verification and validation (for the control software, including the new neuro|inspire planning software), it does not involve a study of an AI model's performance on medical imaging data or its impact on human readers. Therefore, the majority of the acceptance criteria and study details relevant to AI/ML devices cannot be found or inferred from this document. The "Performance Validation" mentioned pertains to the physical and computational accuracy of the robot's positioning capabilities.

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Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

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 and utilizes ultrasonic registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

This Renishaw Mayfield 510(k) summary does not contain information about acceptance criteria and a study demonstrating the device meets those criteria. Instead, it describes a device (Neuromate Frameless Gen II) as a technical update of a previously cleared predicate device (Frameless Neuromate). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific acceptance criteria with a dedicated study.

Specifically, the document states:

• No clinical data are submitted (Section 8). This indicates that there was no human-based study to assess the device's performance against clinical endpoints or acceptance criteria.
• Bench and performance testing showed that neuromate performed as designed and intended (Section 7). This refers to engineering-level testing to verify the device's functionality and compliance with standards (IEC 60601-1, IEC 60601-1-2, FDA software guidance, and IEC 62304), but it does not detail specific acceptance criteria or an associated study.
• The primary justification for market clearance is that the device "is equivalent in design and performance to the predicate device" (Section 9). The "Substantial Equivalence Summary" (Section 10) compares the new device to the predicate across various characteristics, noting similarities and minor differences.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them based on the provided text, as this type of information is not present in the document.

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