(124 days)
Brainlab Elements Guide XT provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Boston Scientific deep brain stimulation (DBS) devices.
Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse generators but does not directly interact with the surgeon. The subject device Brainlab Elements Guide XT consists of multiple software components including the Guide XT 3.0 application that provides the core functionality for stimulation field model creation and visualization in the context of the patient anatomy.
The provided text does not contain detailed acceptance criteria and performance data for the Brainlab Elements Guide XT device. It broadly states that "the device was demonstrated to be as safe and effective as the predicate device" based on "verification and non-clinical tests."
However, I can extract the information that is present and indicate where specific details are missing based on your request.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It only mentions general testing and verification without quantifiable results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "Additionally, the performance test for the VTA (Volume of Tissue Activated) simulation was conducted supporting the use of a proprietary heuristic methodology for the prediction of threshold current (Ith) maps in the vicinity of implanted leads stimulated by the Deep Brain Stimulation (DBS) system from Boston Scientific Neuromodulation (BSN)."
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "performance test for the VTA simulation," suggesting it's likely a retrospective analysis of existing data or a simulated environment, but not explicitly stated as retrospective or prospective human subject data. "Clinical data was leveraged from the existing literature sources to validate the indications and intended use of the device," but this refers to the validation of the indications, not the direct performance test of the device itself. The device "was not used for any clinical tests for the purposes of this 510(k) submission."
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)
This information is not provided. The document describes a "proprietary heuristic methodology" for VTA simulation, but it does not mention expert involvement in establishing ground truth for the performance test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
The document explicitly states: "The Subject Device was not used for any clinical tests for the purposes of this 510(k) submission." Therefore, an MRMC comparative effectiveness study was not conducted with human readers using the device. The device is a "planning software" to "assist medical professionals in planning," so human-in-the-loop performance would be relevant, but it was not tested in this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance test was done for the VTA simulation. The document states: "Additionally, the performance test for the VTA (Volume of Tissue Activated) simulation was conducted supporting the use of a proprietary heuristic methodology for the prediction of threshold current (Ith) maps in the vicinity of implanted leads stimulated by the Deep Brain Stimulation (DBS) system from Boston Scientific Neuromodulation (BSN)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions that the VTA simulation performance test "supporting the use of a proprietary heuristic methodology." This implies the ground truth might have been established through a computational model or prior validated data from Boston Scientific, rather than directly from expert consensus, pathology, or outcomes data from independent cases for this specific performance test. The document does not definitively state the type of ground truth used for this VTA simulation performance evaluation.
8. The sample size for the training set
The document does not mention a training set or its sample size. The VTA simulation uses a "proprietary heuristic methodology," which might imply a model without explicit training data or a model trained externally, but no details are provided here.
9. How the ground truth for the training set was established
Since no training set is mentioned, this information is not provided.
§ 882.5855 Brain stimulation programming planning software.
(a)
Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis must be performed.
(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface components.
(iv) A warning regarding use of the data with respect to not replacing clinical judgment.