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The Sonowand Invite System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner.

The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images

The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.

The 510(k) cleared SonoWand Invite System is a neuronavigation system with intraoperative imaging capabilities. An ultrasound scanner is physically integrated with a neuronavigation system in a single rack of equipment.

SonoWand Invite can be used as a conventional neuronavigation system based on preoperative MR or CT-images, or as a stand-alone ultrasound scanner for real-time 2D imaging or as a combined system where 3D ultrasound data can be transferred to the navigation system for direct navigation.

SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. It also makes it possible for the surgeon to acquire ultrasound images during operation, which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen. The secondary control is by a footswitch.

The new accessories, General purpose localizers with adapters, shall be used to attach surgical tools manufactured by other vendors. SonoWand Invite will then display position and orientation of the tools in the medical images on the screen in the same way as the previous 510(k) cleared Navigator tool.

The localizers with adapters are designed to fit surgical tools normally used in the operating room.

There are no changes to the Intended use, function or technological aspects including software of the SonoWand Invite. The additional accessories are being added to increase usability of the SonoWand Invite system.

The provided text describes a 510(k) submission for new accessories (general purpose localizers and adapters) for the SonoWand Invite System. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study data.

Therefore, the information you've requested regarding acceptance criteria, specifics of a study proving those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is largely not present in this 510(k) summary.

The summary states that the new accessories have been tested to comply with standards and requirements, and that "Results of the tests performed show the General purpose localizers and adapters are as safe and effective as the accessories of the predicate device." However, it does not detail the specific performance metrics or the study design with the granularity you've requested.

Here's what can be extracted and inferred from the provided text, while also explicitly stating what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., accuracy thresholds, precision ranges) are reported in a quantifiable manner, nor are specific performance values provided for the new device or the predicate. The "performance" described is qualitative, stating equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "The Localizers have been tested..." and "The Adapters were tested...", but does not provide the number of localizers, adapters, or test scenarios.
• Data Provenance: Not specified. The submitter is from Norway, but the location where the tests were conducted or the origin of any data (if human subjects were involved, which is not indicated) is not mentioned. The testing is internal to the manufacturer's validation activities for demonstrating substantial equivalence.
• Retrospective/Prospective: Not applicable, as this is a device accessory validation (likely bench testing/engineering validation), not a clinical study involving patients being followed over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not provided. The testing described appears to be technical/engineering validation, not a study where expert interpretations are compared to establish ground truth for image analysis or diagnostic performance.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. This type of information is typically relevant for clinical studies involving multiple readers and often conflicting interpretations, which is not the case described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of new accessories through technical validation, not on comparing reader performance with and without AI assistance.

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

• This is not applicable in the context of these accessories. The SonoWand Invite System itself has software, and the document states: "The devices subject to this submission do not contain software module in the cleared SonoWand Invite System that supports the function of the subject devices has been tested to and complies with requirements." This implies the existing system's software was evaluated, but not these passive localizers/adapters as standalone algorithms.

7. The Type of Ground Truth Used

• For the tests mentioned (cleaning/sterilization, SonoWand Invite System test, fit/calibration/accuracy), the ground truth would be established by engineering specifications, regulatory standards, and measurement references. For example, calibration accuracy would be measured against known precise standards, and fit would be verified against design specifications. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. These accessories are passive mechanical components (localizers and adapters) that enable the tracking of surgical tools. There is no AI model or algorithm being "trained" with data for these specific components. The SonoWand Invite System itself is a neuronavigation system, but the submission is for its accessories.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for these accessories, there is no ground truth establishment for such a set.

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