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Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.

The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).

The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.

For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with LITT 2.1 is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the software tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the software to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.

The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial with LITT 2.1 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device VarioGuide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further manual or robotic alignment to a defined trajectory.

In addition, the subject device offers a set of indication specific instruments to support biopsy, sEEG and LITT procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.

The Alignment Software Cranial with LITT has the following accessories:

• Automatic Registration providing an automatic registration for subsequent use.
• Automatic Registration iMRI providing an automatic image registration for intraoperatively . acquired MR images.

The provided text is a 510(k) summary for the "Alignment System Cranial," which includes "Alignment Software Cranial with LITT." It details the device's indications for use, description, and comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set:
  • Number of registrations: 6
  • Total number of samples: 37 (This likely refers to individual measurements taken over the 6 registrations)
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the study was conducted as "System accuracy testing" to evaluate the device in "a realistic clinical setup and representative worst case scenarios," suggesting it was a controlled, prospective study performed by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts or their qualifications used to establish ground truth for this system accuracy testing. This type of testing typically relies on metrology standards and physical measurements rather than clinical expert consensus for ground truth.

4. Adjudication method for the test set

The document does not specify an adjudication method. For system accuracy testing based on physical measurements, an adjudication process involving human experts is generally not applicable in the same way it would be for image-reading or diagnostic AI.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance data presented is for the system accuracy of the device concerning its ability to align instruments, not for a diagnostic AI algorithm that human readers would interact with. The document explicitly states: "No clinical testing was needed for the Subject Device since optical tracking technology in the scope of image guided surgery for the included indications for use is well established in the market."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The performance study was for the system's accuracy (hardware + software components), which is a key aspect of its standalone functionality in terms of guiding instruments. While it's not an "algorithm only" study in the sense of a pure AI diagnostic tool, it measures the precision of the device's output without direct human interpretation in the loop of the measurement itself. The "Automatic Registration" features (including one for iMRI) are mentioned as accessories, implying an algorithmic component, but specific performance criteria for these AI/ML-based features are not detailed beyond the general system accuracy. The document mentions that "There have been no changes to the AI/ML algorithm" for surface matching for patient registration, implying its prior validation.

7. The type of ground truth used

The ground truth for the system accuracy testing ("positional and angular navigation accuracy") would have been established through precise physical measurements using calibrated instruments and metrological standards (e.g., a coordinate measuring machine or similar setup to establish a true target position against which the device's reported position is compared). It is not based on expert consensus, pathology, or outcomes data, as this is a measurement of mechanical and software precision.

8. The sample size for the training set

The document does not provide information on the sample size for the training set for any embedded AI/ML components (e.g., the AI/ML based model for landmark delivery in surface matching). The focus of this 510(k) summary is on the system accuracy for the LITT indication, and asserts "no changes to the AI/ML algorithm" for patient registration.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for any training set was established for embedded AI/ML components. It only mentions that an existing AI/ML algorithm for surface matching landmarks has not changed.

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