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.

Device Description

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:

Viewing image volumes & models
Image volume conversion
Anatomic fiducial point definition
Segmentation & modeling
Surgical analysis & planning

AI/ML Overview

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

Acceptance Criteria (If stated in document)	Reported Device Performance (If stated in document)
Not explicitly defined, but generally implies: "safely and accurately performing the stated indication for use."	"The results of these studies demonstrate that the device is capable of safely and accurately performing the stated indication for use."

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.

Summary

{0}------------------------------------------------

PlaniSight Linasys 510K Summary

SEP 2 2 2008

Image /page/0/Picture/3 description: The image shows the logo for PTI Surgical Vision and Precision. The logo features a compass-like design on the left side. To the right of the compass is the text "PTI" in a bold, sans-serif font, with the words "SURGICAL VISION AND PRECISION" underneath in a smaller font.

PLANISIGHT LINASYS™ LIVER SURGICAL PLANNING SOFTWARE 510(k) SUMMARY [as required by 21 CFR 807.92(c)]

]. Submitted by:

Pathfinder Therapeutics, Inc. 2969 Armory Drive, Suite #100A Nashville, TN 37204

Establishment Registration Number: 3006587863

ll. Contact Person:

James Stefansic, PhD, MBA Chief Technology Officer Telephone: (615) 783-0094 Fax: (615) 783-0554 E-mail: jds@2pti.com

lll. Date Summary Prepared:

July 31, 2008

IV. Name of the Device:

Proprietary Name: PlaniSight Linasys™ Common / Usual Name: Liver Surgical Planning Software (LSPS) Classification Name: Radiological Image Processing System (per 21 CFR 892.2050) [Class II, Product Code LLZ]

and the contraction of the contribution

and the commend of the comments of

{1}------------------------------------------------

V. · Substantial Equivalence:

The characteristics and indications for use of the PlaniSight Linasys™ device are the same or similar to those found in the predicate device is substantially equivalent to the following FDA cleared Radiological Image Processing Systems:

IQQA Liver Software (EDDA Technology, K061696) 1.
1. MeVis Liver Analyzer / Liver Viewer Software (MeVis-Center for Medical Diagnostic Systems and Visualization, K051528)

VI. Device Description:

Linasys 100 LSPS consists of five (5) functions:

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

VII. Performance Data:

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.

VIII. Indications For Use:

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 semiautomatic 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2008

James D. Stefansic, Ph.D., MBA Chief Technology Officer Pathfinder Therapeutics, Inc. 2969 Armory Drive Suite 100A NASHVILLE TN 37204

Re: K082228

Trade/Device Name: PlaniSight Linasys™ Liver Surgical Planning Software (LSPS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 5, 2008 Received: August 7, 2008

Dear Dr. Stefansic:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

forque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): Kos zzz z

Device Name: PlaniSight Linasys™ Liver Surgical Planning Software (LSPS)

Indications For Use:

Prescription Use X CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Part 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices KO 8222 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).