Search Results

The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Explorer™ Liver system is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver system consists of six (6) components which are listed below:

• An image-guided surgery software platform installed on a personal computer (PC) (1)
• A three lens active-based optical position sensor that can accurately localize the tracked devices (2) listed below
  • A tracked adapter multi tool (used for localization of rigid surgical instruments and to (a) define 3-D surgical space)
  • A tracked laser range scanner (b)
  • A tracked Localization Probe (c)
• An LCD display monitor. (3)

The provided text is a 510(k) summary for the Explorer™ Liver system. It describes the device, its indications for use, and states that performance data from validation and verification studies demonstrate the device's safety and accuracy. However, this document does not contain explicit acceptance criteria or the details of a study that proves the device meets those criteria.

The "Performance Data" section (VII) is very brief and only states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Explorer™ Liver system. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use." It does not provide any specific metrics, thresholds, sample sizes, or methodologies for these studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone study details, types of ground truth, or training set information based solely on the provided text.

The document is a high-level summary for regulatory submission, not a detailed technical report of the studies themselves. To answer your questions, one would need access to the actual validation and verification study reports mentioned.

Ask a specific question about this device

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.

Ask a specific question about this device

The Linasys device is indicated for open liver surgical procedures where imageguidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Linasys (Liver Navigation System) is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Linasys system consists of six (6) components which are listed below:

(1) An image-guided surgery software platform installed on a personal computer (PC)
(2) A three lens active-based optical position sensor that can accurately localize the tracked devices listed below
(3) A tracked localization probe
(4) A tracked fixed reference emitter used to define 3-D surgical space
(5) A tracked laser range scanner
(6) An LCD display monitor.

The provided 510(k) summary for the Linasys Image-Guided Liver Surgery System does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

It broadly states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys Image-Guided Liver Surgery System. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use."

Without specific performance metrics from a study, it's not possible to create the requested table or answer most of the detailed questions.

However, based on the limited information provided, here's what can be inferred or stated about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically include quantifiable metrics for accuracy, precision, reliability, and safety.
• Reported Device Performance: Not explicitly stated in terms of specific numerical outcomes or metrics. The summary only gives a general statement of capability.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set:

• Not mentioned.

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, an MRMC comparative effectiveness study is not mentioned. The Linasys is described as an image-guided surgery system for assisting physicians, not an AI diagnostic tool for "human readers." Therefore, this type of study would not be directly applicable as described.

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

• The document implies the device is an assistance tool for physicians during surgery ("to aid physicians," "used as a guide by the physician"). It is not described as a standalone algorithm performing tasks without human interaction. Therefore, a standalone performance study in the context of an "algorithm only" would be unlikely or not explicitly mentioned here. The "performance characteristics" studies likely refer to the system's accuracy in mapping positions, not an AI's standalone diagnostic capability.

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

• Not mentioned. For a navigation system, ground truth would likely involve highly precise measurements of physical locations and their correlation with imaging data.

8. The sample size for the training set:

• Not mentioned.

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

• Not mentioned.

Summary of what is known from the provided text:

• Device Name: Linasys Image-Guided Liver Surgery System
• Intended Use: To aid physicians during open liver procedures by mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images, guiding localization of tumors and other structures.
• Performance Claim: "Validation and verification studies were conducted to evaluate the performance characteristics... The results... demonstrate that the device is capable of safely and accurately performing the stated intended use."
• Predicate Devices: Several other FDA-cleared frame stereotaxic systems (Medtronic Navigation StealthStation, BrainLAB VectorVision2, J&J ACUSTAR I). This implies the Linasys system's performance metrics, though not detailed, would likely be compared to or fall within the established performance ranges of these predicate devices.

To provide the requested details, additional information from the actual validation and verification study reports would be necessary. This 510(k) summary is a high-level overview.

Ask a specific question about this device