(210 days)
BrainSUITE NET from BrainLAB is a platform for the integration of devices and for the distribution of video signals and multimedia content. It is intended to be used for communication between compatible BrainLAB devices. It provides centralized access for managing video data, medical images and patient data. BrainSUITE NET can be used in the operating theater for various surgical procedures involving video processing, image recording, patient data viewing and software application control.
BrainSUITE NET enables full control of video signals from a single touchscreen interface and display of ore-, intra- and post-operative patient data. Physicians can easily manibulate how and where information is displayed, to monitors for the entire OR team or to remote rooms for consulting and real-time education.
The provided text is a 510(k) summary for the BrainSUITE NET device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed performance study with acceptance criteria, human readers, or ground truth-based evaluation as typically seen for AI/ML-driven diagnostic devices.
Therefore, much of the requested information cannot be extracted from this specific document. The BrainSUITE NET is described as a platform for integrating devices and distributing video signals and multimedia content, essentially a communication and data management system for operating rooms, not a diagnostic or therapeutic device requiring performance metrics like sensitivity or specificity.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implied by 510(k) process) | BrainSUITE NET has been verified according to BrainLAB's procedures for product design and development. The evaluation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with the predicate devices Control Digital Operating Room System (K050209) and Switch Point Infinity (K033132). |
| Conformance to Voluntary Standards | Conforms to IEC 60601-1-1:2000 (Safety Requirements for Medical Electrical Systems) and IEC 60601-1-2:2001 (Electromagnetic Compatibility). |
| Functional Capabilities (Derived from Device Description) | - Video Data Management and Documentation: Can route a wide range of video signals to displays within or outside the OR. Offers preconfigured layouts and viewing modes (e.g., Picture-in-picture, Tile View, Quad View). Allows screenshots and recording of PAL and NTSC signals on DVD. |
- Touchscreen based Centralized Access: Enables full control of video signals from a single touchscreen. Users can switch between devices via a system-wide identical interface. Supports simultaneous use with multiple touchscreens. Access schemes can be defined for security. |
| Substantial Equivalence to Predicate Devices (Regulatory threshold) | Found to be substantially equivalent to Smith & Nephew Control Digital Operating Room System (K050209) and Stryker Switch Point Infinity (K033132). FDA review confirms this. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The document does not describe a performance study with a test set of data (e.g., medical images or patient cases) in the context an AI/ML diagnostic device. The evaluation mentioned is related to product design and development, conformity to standards, and substantial equivalence to predicate devices, not performance on specific clinical data.
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)
- Not Applicable / Not Provided. As there's no mention of a test set requiring ground truth, no experts for this purpose are cited.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or human adjudication process is described for this type of device.
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
- Not Applicable / Not Provided. This is not a diagnostic device with an AI component being evaluated for its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is an integration and communication platform, not a standalone algorithm performing a specific task that would require such evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No ground truth data is mentioned for testing this device. The "evaluation" spoken of relates to system functionality, safety, and equivalence, not to diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
- Not Applicable / Not Provided. This document does not describe the development or training of an AI/ML algorithm that would use a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no mention of a training set, the method for establishing its ground truth is also not applicable.
Summary of Device Evaluation and Regulatory Clearance:
The BrainSUITE NET obtained 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices (Smith & Nephew Control Digital Operating Room System K050209 and Stryker Switch Point Infinity K033132). The evaluation focused on ensuring the device's safety and effectiveness as a system for integrating devices and managing video/patient data in the operating room, and its adherence to relevant safety and electromagnetic compatibility standards (IEC 60601-1-1 and IEC 60601-1-2). This type of clearance does not typically involve the detailed performance metrics and comparative studies associated with AI-powered diagnostic tools.
§ 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).