(142 days)
BrainLAB Spine & Trauma iCT is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 3D image data.
Spine & Trauma ICT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.
The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired CT image.
Spine & Trauma iCT is a device that allows surgical planning and navigation. It links a surgical instrument, (tracked by passive marker sensor system) to a location on a virtual computer image, which is based on patient's preoperative or intraoperative 3D information of a CT dataset
The device enables the navigation based on 3D data.
Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing registration methods as paired point matching, region matching or by an automatic registration.
The automatic registration is based on an initial CT- scanner calibration and on the spatial position of CT- scanner and patient at the beginning of the scan. The calibrated volume is scanned and the 3D dataset and registration information is sent to the navigation computer. Thus, automatic registration is available right after patient scanning during surgery. After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way typically found for performance claims in 510(k) summaries. Instead, it states that the device, Spine & Trauma iCT, 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." It concludes that the information provided to the FDA was found to be "substantially equivalent with the predicate device VV Fluoro 3D (K070106)."
This indicates a reliance on the equivalence to a predicate device and internal validation, rather than a detailed report of a new clinical study with specific performance metrics and acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." |
| Substantial Equivalence to predicate device VV Fluoro 3D (K070106) | Found to be substantially equivalent. |
2. Sample sized used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "patient's preoperative or intraoperative 3D image data" but not the source or nature of the data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method for the test set
- Not specified.
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
- An MRMC study is not mentioned. The device is an image-guided navigation system, not an AI diagnostic tool primarily focused on improving human reader performance in interpreting images. Its function is to assist in surgical procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device description focuses on its function as an "intraoperative image-guided localization system" that "links a freehand probe... to virtual computer image space." This inherently implies human interaction (a surgeon using a probe). Therefore, a purely standalone algorithm evaluation in the sense of a diagnostic AI is not applicable or described. The validation mentioned refers to the system's overall safety and effectiveness in its intended use with a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For a navigation system, ground truth typically relates to the accuracy of probe localization relative to anatomical structures, which would likely be established through physical measurements and imaging.
8. The sample size for the training set
- Not applicable/specified. This is not an AI/machine learning device that typically requires a separate training set in the conventional sense for a 510(k) submission of this type. The "automatic registration" mentioned is based on initial CT-scanner calibration rather than a trained machine learning model.
9. How the ground truth for the training set was established
- Not applicable/specified as there's no mention of a traditional machine learning "training set" for ground truth establishment.
§ 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).