(224 days)
The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Neuro (Release 2) option and the EasyTaxis option are used for support in neurosurgical procedures such as:
- Frameless stereotactic procedures .
- Intra-operative resection of brain tumors .
- Biopsies .
- Endoscopic procedures .
The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation.
The EasyTaxis option is used to assist the surgeon in the positioning of instruments and in guiding an instrument to its targeted position during a surgical procedure when used with the EasyGuide Standard Workstation.
The EasyGuide Neuro (Release 1) Image Guided Surgery Workstation was cleared for marketing via 510(k) 961834. Since then the product structure for EasyGuide has been reconfigured into a basic version known as EasyGuide Standard and options to this version. EasyGuide Standard has also been called EasyGuide Neuro Basic. The EasyGuide Standard Workstation is the same as the EasyGuide Neuro Image Guided Surgery Workstation which was cleared for marketing as noted above. A Neuro (Release 2) option and an EasyTaxis option, which are the subjects of this premarket notification, are options for the Philips EasyGuide Standard Workstation. The Neuro (Release 2) option and the EasyTaxis option extend the functionality and application areas of the EasyGuide Standard Workstation.
The provided document is a 510(k) summary for the Philips EasyGuide Neuro (Release 2) and EasyTaxis options, which are enhancements to an existing Image Guided Surgery System. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria, sample sizes, and ground truth methodologies.
Therefore, the document does not contain the specific information requested regarding acceptance criteria, device performance from a study, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies.
The document primarily states that the device complies with electrical safety standards (UL-2601), electromagnetic compatibility standards (IEC-601-1-2), and digital imaging communication standards (ACR/NEMA DICOM Version 3). These are not performance metrics in the way you might expect for diagnostic or AI-driven devices but rather safety and interoperability compliance.
Here's a summary of what is available in the document, framed against your request, and why other information is absent:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Compliance Statements):
- Compliance with UL-2601 (electrical safety)
- Compliance with IEC-601-1-2 (electromagnetic compatibility)
- Compliance with ACR/NEMA DICOM Version 3 (digital imaging communication)
- Compliance with Title 21 CFR Part 1040.10 (position digitizer laser)
- Reported Device Performance: No quantitative performance metrics are provided in the context of clinical accuracy or efficacy studies. The "performance" described is its adherence to the aforementioned safety and communication standards. This is typical for a 510(k) focused on substantial equivalence for a surgical navigation system, where the efficacy is largely tied to predicate devices and the system's ability to accurately track instruments.
- Acceptance Criteria (Compliance Statements):
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document describes a substantial equivalence submission, which doesn't typically require such detailed clinical study data for device clearance unless significant new claims or technologies are involved that differ substantially from predicates.
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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):
- Not applicable / Not provided. No test set or related ground truth establishment is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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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 / Not provided. This device is a surgical navigation system, not an AI diagnostic tool involving "human readers" in the typical sense.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. The device is inherently-human-in-the-loop as it assists surgeons.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
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The sample size for the training set:
- Not applicable / Not provided.
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How the ground truth for the training set was established:
- Not applicable / Not provided.
In conclusion, this 510(k) document establishes substantial equivalence based on safety, interoperability, and functional similarity to predicate devices, rather than detailed performance studies with acceptance criteria based on clinical outcomes or accuracy metrics for a new, novel technology.
§ 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).