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Intended Use: The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.

Navigus Reusable Passive Probe

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth. The document is an FDA 510(k) clearance letter for a medical device (Navigus Reusable Passive Probe), stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not the technical details of a study or performance criteria.

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The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.

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I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "NeXdrive Disposable Microdrive" and primarily addresses its substantial equivalence to a predicate device and its indications for use.

The letter does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
• Information about training sets.

Therefore, I cannot fulfill your request for this specific information from the provided text.

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Intended Use: The Navigus Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation. The device is provided sterile and for single use.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is primarily a 510(k) clearance letter from the FDA for the 'Navigus Passive Probe', indicating that the device has been found substantially equivalent to a legally marketed predicate device.

Specifically, the text is missing information regarding:

1. A table of acceptance criteria and reported device performance: This information is typically found in a summary of safety and effectiveness, which is not part of this clearance letter.
2. Sample size used for the test set and data provenance: No details about a test set or its origin are present.
3. Number and qualifications of experts: No mention of experts or ground truth establishment.
4. Adjudication method: Not discussed in the document.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information about such a study or effect sizes is provided.
6. Standalone performance: No details about the algorithm's performance without human intervention.
7. Type of ground truth used: The document does not describe the ground truth for any study.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The document only states the device's intended use and that it received 510(k) clearance. To find the information you're looking for, you would typically need to consult the 510(k) summary submitted by the manufacturer to the FDA, which often includes more detailed safety and effectiveness data.

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Intended Use: The Navigus Passive Probe (BL) is intended to be used for trajectory navigation in conjunction with the Navigus family of Image-Guided Systems. The device is provided sterile and for single use.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for a medical device (Navigus Passive Probe (BL)) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices. It confirms the device can be legally marketed but does not include the detailed study information required to answer your request.

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The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Unibody Fiducial Marker System." This type of letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics and is considered as safe and effective.

However, a 510(k) clearance does not typically include the detailed acceptance criteria or the specific study results proving those criteria were met in the way a clinical trial report or a comprehensive technical document would. The FDA letter is a regulatory approval document, not a scientific publication of study findings.

Therefore,Based on the provided document, the following information cannot be extracted:

• A table of acceptance criteria and the reported device performance: The letter states the device is "substantially equivalent" but does not define specific performance metrics or acceptance criteria, nor does it report the device's performance against them.
• Sample size used for the test set and the data provenance: No information about a test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not mention any ground truth establishment for a test set or the involvement of experts for this purpose.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information is available regarding an adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device is a physical "Fiducial Marker System," not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance is not applicable and not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a physical medical device, not an algorithm, a standalone performance study in this context is not relevant and not mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information about ground truth is provided.
• The sample size for the training set: There is no mention of a training set as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable, as there's no training set mentioned.

The document's primary purpose is to grant regulatory clearance by establishing substantial equivalence to a predicate device, not to detail specific performance studies or their methodologies.

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Intended Use: The Navigus Passive Head Restraint System is intended for use in neurosurgical procedures.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Navigus Passive Head Restraint System." This document does not contain information about acceptance criteria, study details, or device performance metrics. It primarily serves as an approval letter, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any tests.
3. Number or qualifications of experts.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Details about standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Navigus Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic provide The device is provided sterile and is for one time use only.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Navigus Fiducial Marker System. It confirms the substantial equivalence of the device to a predicate device and allows it to be marketed, but it does not contain the detailed study information (acceptance criteria, reported performance, sample sizes, ground truth, etc.) that you are requesting.

The letter focuses on regulatory approval and compliance, not the technical study results. Therefore, I cannot extract the specific information you asked for based on this document.

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Intended Use: The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.

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The provided text is a 510(k) premarket notification letter from the FDA to Image-Guided Neurologics, Inc. for their Navigus II Trajectory Guide with Verification Reticules. This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested details based on the input text. The document primarily focuses on:

• Device Name: Navigus II Trajectory Guide with Verification Reticules
• Regulation Number: 882.4560
• Regulation Name: Stereotaxic instrument
• Regulatory Class: Class II
• Product Code: HAW
• Intended Use: To provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.
• Sterilization: ETO sterilized and for one-time use.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.

To answer your request, a document detailing the device's technical specifications, validation studies, and performance data would be required.

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Intended Use: The Manual Disposable Micro-drive with Digital Display is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a medical device.

The provided text is a 510(k) clearance letter from the FDA for the "Navigus Manual Disposable Microdrive with Digital Display." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It outlines regulatory information, but does not contain details about performance studies or acceptance criteria met by the device.

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Intended Use: The NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus II MR Trajectory Guide." It primarily focuses on the regulatory clearance process and does not contain the specific technical study details or acceptance criteria you've requested.

Therefore, I cannot provide the information you've asked for based solely on this document. The letter states that the device is "substantially equivalent" to a legally marketed predicate device, but it does not include the performance data, acceptance criteria, or study details that would typically be found in a 510(k) summary or within the actual submission that was reviewed by the FDA.

To answer your questions, I would need access to the full 510(k) submission document, specifically the sections detailing the performance data, testing protocols, and clinical or non-clinical studies.

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