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The PlaniSight Linasys™ device is intended for liver surgery preoperative planning. The medical image data utilized is derived from various sources, including CT and MRI scanners. The software provides tools for 3-D visualization and volume measurement of structures in the liver following manual or semi-automatic segmentation of the liver organ, intrahepatic vessels, and physician-identified lesions. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections that divide the liver and calculate margins around lesions. Data can be exported in a format suitable for image-guided surgery with the SurgiSight Linasys device. Typical users of the software are trained professionals, including physicians, nurses, and technicians.

The PlaniSight Linasys 100 Liver Surgical Planning Software (LSPS) is a self-contained, PC-based and noninvasive software application that imports medical images (CT or MRI scans) in a DICOM format. Like the predicate devices, Linasys™ LSPS is used to analyze data for preoperative planning in liver surgery. It can also output the image and model data for the use of other device, such as SurgiSight Linasys™ Image Guided Liver Surgical System (IGLSS).

Linasys™ LSPS contains dedicated functions to prepare the image data and define fiducial points for use with the SurgiSight Linasys™ IGLSS system. The LSPS device also includes dedicated functions for segmentation and modeling of organ, tumor, intrahepatic vasculature, and surgical resection planes. Quantitative measurements of functional and residual liver volume allow surgeons analyze the case and make optimal liver surgical plans.

Linasys 100 LSPS consists of five (5) functions:

1. Viewing image volumes & models
2. Image volume conversion
3. Anatomic fiducial point definition
4. Segmentation & modeling
5. Surgical analysis & planning

The provided 510(k) summary for the PlaniSight Linasys Liver Surgical Planning Software does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or details of a comprehensive study proving the device meets acceptance criteria in the manner typically expected for AI/ML-based diagnostic devices.

The summary states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys™ LSPS. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated indication for use." However, it does not provide the quantitative results or the methodology of these studies.

Therefore, many of the requested details cannot be extracted from this document. Below is a breakdown of what can be inferred or is directly stated, and what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document mentions "medical image data utilized is derived from various sources, including CT and MRI scanners," but does not detail the nature of this data for testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and 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, and the effect size of human readers improving with AI vs. without AI assistance

• Not specified. The document primarily focuses on the device's standalone functions for pre-operative planning, quantitative measurements, and visualization tools, rather than its impact on human reader performance in a comparative study.

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

• The document implies standalone testing of its functionalities ("Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys™ LSPS"). However, specific metrics for standalone performance (e.g., segmentation accuracy, volume measurement error against a reference standard) are not provided. The software's functions are described as direct tools for analysis, suggesting a standalone evaluation of their output.

7. The Type of Ground Truth Used

• Not specified. Given the nature of the device (liver surgical planning, segmentation, volume measurement), common ground truth types would typically involve manual expert segmentation, intraoperative measurements, or pathology reports for tumor characterization, but none are mentioned.

8. The Sample Size for the Training Set

• Not applicable/Not specified. The document describes the software as performing "manual or semi-automatic segmentation" and providing "tools," suggesting it's primarily a tool-based system rather than a deep learning/AI model that undergoes explicit "training" in the modern sense. Older software with "semi-automatic" features often relied on traditional image processing algorithms configured or calibrated, rather than trained on large datasets.

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

• Not applicable/Not specified (refer to point 8).

Summary of Missing Information:

The 510(k) summary for PlaniSight Linasys™ Liver Surgical Planning Software provides a general statement of verification and validation but lacks specific quantitative details about acceptance criteria, study design parameters (sample sizes, data provenance, ground truth establishment, expert involvement), and detailed performance results that would illustrate how the device meets any specific criteria. This level of detail is more commonly found in 510(k)s for newer AI/ML-based devices. For a 2008 submission, the regulatory requirements for performance data were often less prescriptive regarding quantitative metrics for software tools. The focus seems to have been on demonstrating the functionality and safety of the software as a medical device rather than proving a specific clinical efficacy or improvement over human performance.

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