(129 days)
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 is a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement e.g. from catheter suppliers can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. iPlan Flow does not generate or create rules for the placement of intracranial catheters by any means. iPlan Flow uses MR-DTI and T2weighted MR images to suggest likely volumes of fluid distribution.
The Primary mode of action for iPlan Flow is a device for creating treatment plans for stereotactic or image guided surgical treatment, especially for the creation of plans for the placement of intra-cranial catheters.
The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.
Like iPlan!FLOW (K041330), iPlan Flow is a software tool running on a standard, standalone 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!FLOW (K041330) iPlan Flow provides e.q. tools for the automatic or manual segmentation of anatomical structures which enables the user such as radiologists or neurosurgeons to quickly achieve the desired seamentation results through an unlimited number of automatic and/or manual re-segmentations. Like the predicate device iPlan!FLOW (K041330) iPlan Flow can be used for the planning of intracranial catheters, with image guided surgery. Guidelines provided e.g. by the catheter suppliers for the exact placements of intracranial catheters can be visualized. These quidelines 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. In addition to the predicate device the depth guideline can be calculated from the flow rate and the catheter diameter and warnings will be displayed if the trajectory of a planned catheter is likely to cross an intra-cranial surface. iPlan Flow is able to calculate a likely fluid distribution from the planned catheter positions to support the physician in his decision about appropriate catheter positions.
These features enable 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 is a 510(k) summary for the iPlan Flow device. It states that "The validation proves the safety and effectiveness of the system," and that the device was found "substantially equivalent" to its predicate device, iPlan!FLOW (K041330). However, the document does not describe any specific acceptance criteria for performance metrics or any detailed study demonstrating that the device meets such criteria.
Therefore, many sections of your request cannot be fulfilled based on the given document.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the device was "verified and validated according to BrainLAB's procedures for product design and development" and was found "substantially equivalent" to the predicate device. However, it does not specify any quantitative acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) or report specific performance metrics for the iPlan Flow device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, its sample size, or data provenance.
3. 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)
- Cannot be provided. The document does not describe any specific test set or the establishment of ground truth for such a set. It mentions that the software enables users like "radiologists or neurosurgeons to quickly achieve the desired segmentation results through an unlimited number of automatic and/or manual re-segmentations," but this refers to the use of the device, not the process of establishing ground truth for a validation study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information about a test set or adjudication methods is present.
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
- Cannot be provided. The document does not describe an MRMC study or any results related to human reader improvement with or without AI assistance. The device is a "planning system" and an "aid" for surgeons in planning, not directly an AI for improving human reader diagnostic performance in a typical MRMC study context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. While iPlan Flow is a software tool, the document doesn't detail a standalone performance study in the way this question implies (e.g., algorithmic accuracy without human interaction on a test dataset). Its functionality is inherently tied to assisting human planning.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. The document does not describe the specific ground truth used for any validation studies.
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set or its sample size.
9. How the ground truth for the training set was established
- Cannot be provided. The document does not mention a training set or how its ground truth was established.
Summary based on the provided text:
The 510(k) summary for iPlan Flow (K053164) focuses on demonstrating substantial equivalence to its predicate device, iPlan!FLOW (K041330). It states that the device was "verified and validated according to BrainLAB's procedures for product design and development" and that "The validation proves the safety and effectiveness of the system." However, it does not provide the detailed study results, acceptance criteria, sample sizes, ground truth establishment methods, or expert qualifications that would be required to answer your specific questions about performance metrics and validation studies. Such detailed information is typically found in the full 510(k) submission, which is more extensive than the summary provided.
§ 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).