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Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/ CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

The Subject Device is intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

In a spinal context, Automatic Registration serves as accessory to the Spine & Trauma navigation system.

The Matrices are reusable devices delivered in non-sterile condition. The devices makes the Correlation ("Registration") of Intraoperative acquired patient data to the surgical environment possible by determining its position in relation to the patient and the navigated instruments.

The document describes K203679, a premarket notification for the "Automatic Registration" device by Brainlab AG. The device is a surgical device for image-guided surgery intended to be used in combination with compatible Brainlab navigation systems, providing image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.

Here's an analysis of the acceptance criteria and study data provided:

Acceptance Criteria and Device Performance

Note: The study for the subject device (Automatic Registration) used stricter acceptance criteria for its own evaluation (mean navigation accuracy: <= 1.5mm, 95th percentile of single navigation accuracy: <= 2.5mm) and successfully met them, demonstrating better performance than the predicate device. The table above compares its performance against the predicate's acceptance criteria to show superiority.

Study Details

1. Sample sizes used for the test set and data provenance:

   • Test set sample size:
     • Total number of navigation points: n = 228
     • Total number of scans used: m = 50
   • Data provenance: "simulated test environment"

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not specified. The document indicates a "simulated test environment" and accuracy measurements, but does not mention human experts establishing ground truth for the test.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by direct measurement in a simulated environment, not by human review and adjudication.

4. Multi Reader Multi Case (MRMC) comparative effectiveness study:

   • No MRMC comparative effectiveness study was done. The study focuses purely on the device's accuracy in a standalone/simulated setting, not on its impact on human reader performance.

5. Standalone performance:

   • Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The data presented reflects the "Automatic Registration" device's accuracy in a simulated environment.

6. Type of ground truth used:

   • The ground truth was established through direct measurement of navigation accuracy in a "simulated test environment." This implies a precisely controlled and measurable setup where the true position is known.

7. Sample size for the training set:

   • Not specified. The document only mentions the test set used for performance evaluation.

8. How the ground truth for the training set was established:

   • Not specified, as the training set details are not provided.

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