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Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The AIM Light Source (L10 and L11 LED Light Source) and SafeLight™ Cable are part of the AIM (Advanced Imaging Modality) System. The AIM System is an endoscopic real-time visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures, respectively. The AIM Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination. The SafeLight Cable transmits light from the light source to an endoscope during endoscopic procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance targets for the device's diagnostic or imaging capabilities. Instead, it focuses on the device passing various design and safety standards. The "Performance - Animal" section states "Equivalent" to a legally marketed predicate device, which implies a comparative performance but doesn't quantify specific metrics.

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

• Sample Size: The document mentions "Performance - Animal" testing. However, it does not specify the sample size (i.e., the number of animals or cases) used for this test set.
• Data Provenance: The study mentioned is an animal study. The location or specific details of the study (e.g., country of origin, retrospective or prospective) are not provided, other than it being "in accordance with 21CFR58" (which refers to Good Laboratory Practice for nonclinical laboratory studies).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The type of animal study described generally wouldn't involve human expert readers in the same way a diagnostic imaging study would. The assessment of "equivalence" likely refers to objective measurements or observations in the animal model.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Since no information is given about human experts establishing ground truth or their interpretations, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance

An MRMC comparative effectiveness study was not done. This document describes an imaging modality that assists surgeons with real-time visualization, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable in the context of the device described. The AIM Light Source and SafeLight Cable are imaging hardware designed to provide real-time visible and near-infrared fluorescence imaging to a human surgeon. It's not a standalone algorithm that provides an output without human interpretation. Its performance is about the quality of the image delivered for human assessment.

7. The Type of Ground Truth Used

For the "Performance - Animal" study, the ground truth would be established through direct observation and/or histological analysis in an animal model, validated against the known physiological processes of blood flow, tissue perfusion, biliary ducts, and lymphatic system activity when ICG is administered. The equivalence claim against a predicate device suggests that the ability to visualize these features was compared.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is an imaging hardware system, not a machine learning or AI algorithm that requires a separate training set. Its development would involve engineering and physical testing, not data-driven model training.

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

This information is not applicable/not provided for the same reason as point 8.

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