(122 days)
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including - image preparation - - image fusion - image segmentation - where the result is used for the creation of treatment plans for Stereotactic Surgery: - Surgery Planning - BrainMAP - Functional Planning In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including - image preparation - - image fusion - image segmentation - where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for: Image Guided Surgery BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or verfebra, can be identified relative to a CT, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: - Cranial procedures - -Spine procedures - -ENT procedures Additional Indications For Use: iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.
iPlan! FiberTracking is developed to enhance functionality of iPlan! Cranial software with the import and planning of diffusion tensor images (DTI). Additional to the basic functions of iPlan! (viewing, drawing, image fusion and planning) this application provides functions for the import and display MRI anisotropic data, image processing of the DTI data and the display of the calculated fiber tracts.
The provided 510(k) summary for iPlan! FiberTracking does not contain explicit acceptance criteria or a detailed study proving the device meets said criteria.
The document states:
"iPlan! has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with the predicate device iPlan! (K020631)."
This statement indicates that a validation process was undertaken, but it does not specify the acceptance criteria used for the validation or details of the study itself. Without this information, I cannot complete the requested tables and descriptions.
Therefore, the following information cannot be extracted from the provided text:
- Table of Acceptance Criteria and Reported Device Performance: This would require specific performance metrics and thresholds, which are not present.
- Sample size used for the test set and data provenance: No information on the dataset used for testing.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not specified.
- Adjudication method for the test set: Not mentioned.
- 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: This is a software component of a planning system; such a study is not typically described in this context for this type of device, and no such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not specified.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 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).