(194 days)
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, Xray(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
The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment.
In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR. X-rav(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 Surgerv
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, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to: - Cranial procedures
- Spine procedures
- ENT procedures
- Hip procedures
- Knee procedures
iPlan! is a software tool running on a standard, standalone computer workstation or being accessable via the intranet connection for pre- or intraoperative planning of treatments based on stereotactic systems or image quided surgery systems.
The system provides e.g. tools for the automatic or manual segmentation of anatomical structures which helps the user such as the radiologist or the surgeon to quickly achieve the desired segmentation results through an unlimited number of automatic and/or manual re-segementations. Additionally anatomical and functional structures and segmentations of the human brain as defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren brain atlases can be correlated with the patient´s brain data.
The created treatment plans of iPlan! can be used on its own or in conjunction with other Brainl.AB medical devices such as VectorVision for performing the planned treatment.
The provided 510(k) summary for the iPlan! device focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and general description. It does not contain specific information about formal acceptance criteria, a dedicated study proving performance against those criteria, or details regarding ground truth establishment and expert adjudication for either test or training sets.
Therefore, much of the requested information cannot be extracted from this document. The sections below will indicate where information is missing.
Acceptance Criteria and Reported Device Performance
Not explicitly defined in the provided document. The 510(k) summary 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 system." However, it does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or report specific performance metrics against such criteria in a table format. The primary "performance" mentioned is the device's ability to be "substantially equivalent" to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Study Proving Device Meets Acceptance Criteria
As specific acceptance criteria are not detailed, a formal study explicitly demonstrating the device meets those criteria is not described in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices.
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not mention the sample size or provenance of any test set used for validation.
2. 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 provided. Details regarding ground truth establishment for a test set, including the number and qualifications of experts, are absent.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. The document does not describe any adjudication method.
4. 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 provided. The document does not mention an MRMC study or any results related to human reader improvement with or without AI assistance. The iPlan! device itself is a planning software, not specifically an AI-driven image interpretation tool in the modern sense. Its function is to prepare and present data, and assist in planning, rather than to make diagnostic interpretations that would be compared with human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly detailed as a standalone performance study. The device is described as a "software tool" that provides "e.g. tools for the automatic or manual segmentation." While automatic segmentation implies an algorithm's performance, no standalone performance metrics (e.g., accuracy of segmentation without human interaction) are reported. The device is designed to be used by radiologists or surgeons, implying a human-in-the-loop context.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided for any formal validation study. The document mentions the use of "Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases" for the BrainMAP module to define anatomical and functional structures. This would serve as a form of anatomical ground truth for positional information within the software, but it's not described as part of a formal validation study with patient-specific ground truth.
7. The sample size for the training set
- Not provided. The document does not typically discuss training sets for this type of software in this era (2002), as it's not described as a machine learning/AI product in the contemporary sense. It's a planning tool with segmentation and atlas-correlation capabilities.
8. How the ground truth for the training set was established
- Not provided. As no training set is mentioned in the context of machine learning, ground truth establishment for such a set is not applicable or described. Any embedded anatomical knowledge in the software would likely be derived from established anatomical atlases and medical literature, such as the Talairach/Tournoux and Schaltenbrand/Wahren atlases 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).