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The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.

Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.

The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.

ActivSight consists of the following reusable components:

• ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
• ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
• ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
• ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.

ActivSight consists of the following disposable components:

• ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
• -ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.

The provided text describes the ActivSight Intraoperative Imaging System, its indications for use, and a comparison to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.

The document primarily focuses on regulatory approval (510(k) submission) by demonstrating substantial equivalence to a legally marketed predicate device. While "Performance Data" is mentioned, it refers to compliance with general safety and performance standards (e.g., IEC standards for electrical safety, software lifecycle) and an animal study for comparative visualization, not a clinical study to establish quantitative performance against defined acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide the available information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document focuses on demonstrating compliance with general safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62366-1, ANSI AAMI IEC 62304, IEC 60825-1, IEC 60601-2-18) and a "design validation in an animal study." However, specific quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or other clinical efficacy metrics are not provided, nor are the detailed results of such performance against these criteria.

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

• Test Set Sample Size: Not specified for any clinical performance or validation study against specific acceptance criteria. The document mentions an "animal study" for design validation, but details like the number of animals or specific data points are omitted.
• Data Provenance: The "design validation" was conducted as an "animal study." No information on a human test set or its provenance (e.g., country of origin, retrospective/prospective) is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document refers to an "animal study" for comparative visualization against a predicate's ICG mode, but this is not a human MRMC study to assess reader improvement with AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: The document describes the device (ActivSight) and its capabilities, including "real-time endoscopic fluorescence and near-infrared imaging" and enabling surgeons to "visually assess vessels, blood flow, and related tissue perfusion." The "animal study" compared ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode in terms of "comparatively visualizing blood flow and perfusion." This suggests evaluating the device's imaging capabilities (algorithm included), but it is not framed as a formal "standalone performance study" with defined metrics like sensitivity/specificity for disease detection, or an "algorithm only" evaluation completely separated from the hardware and human interpretation, as typically meant by standalone performance in AI/ML medical devices. The primary focus is on the device as a whole system providing real-time visualization.

7. Type of Ground Truth Used

• Ground Truth Type: For the "animal study," the ground truth for "comparatively visualizing blood flow and perfusion" is implied to be direct visual assessment by the comparing technologies (ActivSight's modes vs. predicate's ICG mode). The document does not specify an independent, objective ground truth established by pathology, outcomes data, or expert consensus beyond the visual comparison of the imaging techniques themselves.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. The document does not mention details about algorithm training or associated datasets.

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

• Ground Truth Establishment for Training Set: Not specified, as training set details are not provided.

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