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The PerculVav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PerculNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting.

The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.

The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:

• · Image fusion for diagnostic clinical examinations and procedures
• · Soft tissue biopsies
• · Soft tissue ablation
• Bone ablation
• · Bone biopsies
• · Nerve blocks and pain management
• · Drainage placements

The Philips PercuNav Image Fusion and Interventional Navigation System provides image-guided diagnostic and intervention that enables fusion of diagnostic images and guidance of tracked instruments to physiciandefined targets. The target can be indicated either pre-procedurally or intra-procedurally, either using images or relative to an indicated position on the patient. The system transforms two-dimensional patient images into dynamic representations that can be fused with live ultrasound or other previously acquired images. Those two-dimensional patient images, or scan sets, are derived from Ultrasound, CT, PET, PET/CT, and MRI. The resulting dynamic representation supports diagnostic review and instrument navigation.

The purpose of this Traditional 510(K) Pre-market Notification is to introduce a new semi-automated visualization tool entitled "Tumor Contouring" to the current PercuNav software system. The Tumor Contouring visualization tool is designed to aid the end user in the planning and targeting of lesions, structures, and other regions of interests prior to an interventional procedure, soft tissue ablation, etc. The Tumor Contouring tool allows the end user to generate and modify a 3D contour around a region or soft tissue structure of interest and then this contour, once accepted by the user, can be visualized and dynamically reformatted and fused in various imaging combinations for later procedures.

The provided text includes a 510(k) summary for the Philips PercuNav Image Fusion and Interventional Navigation System with a new "Tumor Contouring" visualization tool. However, it does not contain explicit acceptance criteria thresholds or detailed study results for the device's performance, as would typically be found in a clinical study report.

The document focuses on demonstrating substantial equivalence to predicate devices through technological comparison and non-clinical testing (software verification, risk analysis, product specifications, design reviews). It explicitly states: "The subject Philips PercuNav System did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s)."

Therefore, based on the provided text:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No specific sample size for a "test set" (in the context of clinical or performance data) or data provenance is mentioned. The testing described is primarily internal software verification.

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. The document does not describe a study involving expert-established ground truth for performance evaluation of the Tumor Contouring tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No such adjudication method is mentioned as part of the described testing.

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:

No MRMC comparative effectiveness study was done or reported in this document.

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

The "Tumor Contouring" tool is described as "semi-automated," generating a preliminary border that the user must modify and review. This indicates it is not a standalone algorithm without human-in-the-loop performance. The document does not describe a standalone performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The document focuses on software verification against specifications and user needs rather than clinical ground truth for the Tumor Contouring feature. The closest mention of "ground truth" would be the implicit correctness against internal software design specifications.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as the device's submission did not involve clinical data or machine learning model training in the context of this summary.

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

Not applicable, as no training set is described.

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