(126 days)
iPlan!FLOW's indications for use incorporate the indications for use of iPlan! and thus is to prepare and present patient related medical image data based on CT and/or MR including
- image preparation -
- image fusion -
- image segmentation -
display of guideline-visualizations for planning the placement of intra-cranial catheters where the result is used for the creation of treatment plans for:
Stereotactic Surgery:
The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels.
The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach.
In addition iPlan!FLOW's indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro), Angiographic and other imaging sources 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) or 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 vertebra, can be identified relative to a CT or MR based model of the anatomy.
The surgeon can interactively change a probe path simulation through the image slices in the software and graphical manipulate trajectories to optimize his approach. An intra-cranial catheter can be chosen and the path of the catheter can be planned. The user is provided with information by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of this catheter on brain structures or to a preplanned trajectory .
iPlan!Flow can visualize guidelines for better placement of intra-cranial catheters. These guidelines comprise the minimal depth of the catheter tip in the brain tissue, the minimal distance of the catheter tip from intra-cranial surfaces and the minimal distance between different catheter tips. This visualization enables the surgeon to better plan and place intra-cranial catheters.
iPlan!FLOW is designed as a planning system for pre- and intraoperative planning of stereotactic or image guided surgery treatments. It is specially designed to display anatomical images of a patient acquired with MR and/or CT as well as images derived from DTI-data acquired with Magnetic Resonance Imaging (MRI). iPlan!FLOW has a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement from the catheter supplier can be visualized and displayed to support the surgeon in improving catheter placement planning. iPlan!FLOW does not generate or create rules for the placement of intracranial catheters by any means. The Primary mode of action for iPlan!Flow is a device for creating treatment plans for stereotactic or image guided surqical treatment.
The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.
Like iPlan!® (K020631), iPlan!FLOW is a software tool running on a standard, stand-alone computer (PC or Laptop) or being accessible via the intranet connection for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems.
Unchanged to iPlan!® (K020631) iPlan!FLOW provides e.g. tools for the automatic or manual segmentation of anatomical structures which enables the user such as radiologists or neurosurgeons to quickly achieve the desired segmentation results through an unlimited number of automatic and/or manual re-segmentations. Additionally to the predicate device iPlan! functional data derived from the Diffusion Tensor acquired by Magnetic Resonance Imaging (MRI) like maps of the fractional anisotropy (FA-Maps) and maps of the apparent diffusion coefficient (ADC-Trace-Map) can be displayed and matched with the anatomical data.
In addition to the trajectory-planning capabilities of iPlan!, iPlan!FLOW can be used for the planning of intracranial catheters, with image guided surgery. Guidelines provided by the catheter supplier for the exact placements of intracranial catheters can be visualized. These guidelines comprise the minimal depth of the catheter tip in the brain tissue, the minimal distance of the catheter tip from intra-cranial surfaces and the minimal distance between different catheter tips. This visualization enables the surgeon to better plan and place intra-cranial catheters.
The created treatment plans of iPlan!FLOW can be used on its own or in conjunction with other BrainLAB medical devices such as VectorVision for performing the planned treatment.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the format typically found in clinical trial reports or validation studies. Instead, it is a 510(k) summary for a medical device (iPlan!FLOW), which focuses primarily on establishing substantial equivalence to a predicate device.
However, based on the information provided, we can infer some aspects related to validation and equivalence.
Here's a breakdown of the requested information, addressing what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The 510(k) summary states that "iPlan!FLOW has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." However, it does not specify the quantitative acceptance criteria (e.g., accuracy, precision thresholds) or detailed reported performance metrics for these criteria.
2. Sample size used for the test set and the data provenance
This information is not explicitly provided in the document. The text does not describe a specific test set, its sample size, or the provenance of the data used for validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided in the document. While it mentions that "radiologists or neurosurgeons" would use the device, it doesn't detail their involvement in establishing ground truth for a test set used in the validation.
4. Adjudication method for the test set
This information is not explicitly provided in the document. Since a detailed test set and ground truth establishment method are not described, an adjudication method is also not mentioned.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed or any effect size related to human reader improvement with AI assistance. The device is a planning system, and its validation focuses on its ability to support planning, not directly on improving human reader diagnostic accuracy in a comparative study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, iPlan!FLOW, is described as a "software tool running on a standard, stand-alone computer," which implies its functionality is standalone in terms of computation. However, its stated purpose is to "prepare and present patient related medical image data" for use by a surgeon for planning. It is an aid to a human user, not an autonomous diagnostic or therapeutic algorithm. Therefore, a standalone "algorithm only without human-in-the-loop performance" study as typically understood for AI diagnostic tools would not be directly applicable in the same way. The validation would instead focus on the accuracy of its planning tools and visualizations. The document does not describe such a study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly provided in the document. Given that the validation "proves the safety and effectiveness of the system," it likely involved comparing the device's outputs (e.g., planned trajectories, segmentations, visualizations) against established anatomical knowledge, surgical principles, or potentially phantom studies, but the specific type of ground truth is not detailed.
8. The sample size for the training set
This information is not explicitly provided in the document. The 510(k) summary does not describe the development or training of any machine learning components in a way that would require a "training set" in the context of AI development. It functions more as a sophisticated software tool for image processing and visualization.
9. How the ground truth for the training set was established
This information is not explicitly provided in the document, for the same reasons as #8.
Summary of Device Validation and Equivalence (based on the provided text):
The 510(k) summary establishes that iPlan!FLOW is substantially equivalent to its predicate device, iPlan!® (K020631). The basis for this claim is:
- Similar Indications for Use: iPlan!FLOW incorporates the indications of iPlan! for preparing and presenting patient medical image data for stereotactic surgery planning, including image preparation, fusion, and segmentation.
- Expanded Indications: iPlan!FLOW adds indications for preparing and presenting data from additional sources (X-ray, Angiographic) and supports preplanned data for other BrainLAB devices (e.g., VectorVision) for image-guided surgery. It also specifically adds capabilities for planning intracranial catheter trajectories with visualization of supplier guidelines.
- Similar Technology: Both are software tools running on standard computers for pre- or intraoperative planning.
- Added Features: iPlan!FLOW includes additional features like displaying functional data from Diffusion Tensor Imaging (DTI-MRI) (FA-Maps, ADC-Trace-Map) and specific tools for planning intracranial catheters.
- Internal Validation: "iPlan!FLOW has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." This suggests internal testing and adherence to quality systems, but specific details of these tests are not publicly disclosed in this summary.
In essence, the document presents a regulatory justification for market clearance based on substantial equivalence, rather than a detailed scientific study report with explicit acceptance criteria and performance data.
§ 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).